Clinical Research Regulation For Peru and Thailand

Last content review/update: April 24, 2024

Overview

In accordance with the provisions delineated in Decree021-2017, the INS-CTManual, and Res252-2022 (which amends the INS-CTManual), Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) is responsible for reviewing and approving clinical trial applications using registered or unregistered investigational drug products. As per Decree021-2017, the scope of the INS’s assessment includes Phases I through IV clinical trials for pharmaceuticals including medicines, herbal medicines and other complementary products, dietetic products and sweeteners, biological products, and compounded (galenic) products. As specified in Decree021-2017, Res655-2019 (which amends Decree021-2017), the INS-CTManual, Res252-2022, and PER-61, the INS’s review and approval of a clinical trial application is dependent upon obtaining proof of approval from an accredited ethics committee (EC). Therefore, the INS and EC reviews may not be conducted in parallel.

Per the INS-CTManual and Res252-2022, EC approval of the research protocol and the informed consent form (ICF) must be submitted as part of the clinical trial application dossier in order for the INS to conduct its review. PER-83 further specifies that the sponsor or the contract research organization (CRO) must provide a copy of the research protocol and ICF that is stamped and signed by the EC in its entirety as evidence that the approved version is being presented. Refer to the INS-CTManual and Res252-2022 for additional submission information. Per Res0423-2019, the application for clinical trial authorization and corresponding instructions are in PER-24 and PER-10, respectively.

In addition, per Decree021-2017, the sponsor must also ensure authorization by the research institution where the clinical trial will be carried out.

Decree021-2017 states that the investigational product (IP) must meet at least one (1) of the following conditions to be authorized for use in clinical trials in Peru:

Must be approved for use in humans by drug regulatory authorities of countries with high health surveillance

Is produced in Peru, is used in preclinical research, and complies with Ministry of Health of Peru (Ministerio de Salud del Perú (MINSA))’s political and/or research priorities

Will serve to establish pharmaceutical therapeutic equivalence

Is considered a priority for the country’s public health or is within the scope of MINSA policies and/or research priorities
At the request of the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)), requires a clinical trial to support its efficacy and safety for the health registry

Per Decree016-2011, the following are considered to be countries with high health surveillance: France, Holland, United Kingdom, United States, Canada, Japan, Switzerland, Germany, Spain, Australia, Denmark, Italy, Norway, Belgium, and Sweden.

Clinical Trial Review Process

In accordance with Decree021-2017, Res184-2023, Decree028-2023 (which amends Decree021-2017), the INS-CTManual, and Res252-2022, the INS’s Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) (formerly known as the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT))), is responsible for conducting the review and approval of clinical trial applications. As per Decree021-2017 and Res252-2022, the INS also requests that the ANM assess the safety and quality of the IP to be used in a clinical trial and issue a binding technical opinion as part of the INS’s application review and approval process. Following a review of the research protocol, the ANM technical opinion, and other required documentation included in the application package, the INS will approve the clinical trial. (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)) (PER-109)).

Decree021-2017, the INS-CTManual, and Res252-2022 also note that the Clinical Trials Subdirectorate will be able to convene a technical commission of experts when controversial situations arise during the authorization process.

In addition, per Decree021-2017, the INS-CTManual, and Res252-2022, if the clinical trial is related to an IP for the prevention, diagnosis, or treatment of tuberculosis or HIV/AIDS infection, the specific technical opinion of the MINSA’s General Directorate of Strategic Interventions in Public Health (Dirección General de Intervenciones Estratégicas en Salud Pública (DGIESP)) will be requested to ensure the study does not interfere with its strategic interventions regarding these diseases.

Decree021-2017 and the INS-CTManual state that the INS’s DIIS grants clinical trial authorization for the total period of time scheduled for its completion as indicated in the PER-89 registration form submission. Further, per Decree021-2017, once the INS has completed the authorization process, the agency will post the approval status of a clinical trial via PER-89. The following application requirements, which align with the World Health Organization’s Trial Registration Data Set (PER-86), will also be provided in the approval status record: study title, sponsor and investigators, IP, condition under study, study design, and number of participants. See PER-111 for additional information on REPEC’s trial data record requirements. Refer to the INS-CTManual and Res252-2022 for details on the DIIS application review process, and PER-6 for a flowchart delineating the clinical trial authorization process.

See the Submission Process, Submission Content, and Timeline of Review sections for detailed submission and review requirements.

Per Decree021-2017, any modifications of the conditions under which a clinical trial was authorized, and amendments to the research protocol and/or informed consent, require prior authorization from the INS’s DIIS. The following are grounds for modification of clinical trial authorization conditions:

Expansion of the number of research sites
Expansion or modification of the list of supplies to be imported
Change of sponsor or CRO
Change of principal investigator (PI)
Extension of time for conducting the clinical trial
Closure of a research site for a clinical trial
Suspension of clinical trial
Cancellation of clinical trial

Decree028-2023 and Res184-2023 further modify Decree021-2017 to distinguish between amendments and minor changes to the protocol and/or ICF. The updated definition of amendment specifies that an amendment refers to a substantial change(s) that modifies the original version of the protocol and/or ICF and requires INS and EC reauthorization. A minor change(s) is defined as one proposed by the sponsor that complies with Decree028-2023 and the DIIS issued standards delineated in Res184-2023, and the responsibility for executing the protocol remains with the sponsor. Per Decree028-2023, a minor change(s) only requires the approval of the INS registered and accredited EC that originally approved the current version, and the sponsor must communicate the change(s) in writing to the INS’s DIIS prior to its implementation.

Res184-2023 states that changes or modifications must meet certain criteria to be considered minor changes. For changes that are not considered minor, it is necessary to initiate the corresponding amendment procedure delineated in Decree021-2017. Moreover, any new safety information derived from the Investigator’s Brochure is not considered a minor change. See the Scope of Review section and Res184-2023 for detailed descriptions of minor changes to the protocol and/or ICF that do not require DIIS approval.

See also the Submission Process section for additional information on trial extension documentation and review requirements.

Chapter VII (7.1) and Annex 4 (Flowcharts No. 01-04)

Preface, Articles 1-2, and Annex 1

Annex B

Preface, Article 1 (Articles 2 (10) and 40), Article 2 (Articles 2 (48), 6, and 85-A), and Article 3 (Final Complementary Provision)

Preamble, Article 3, and Annex 3

Preamble, Requirements for Initiating the Procedure (3, 10, and 13), and Annexes 1-3 and 9

Title II (Articles 10 and 21)

Title I (Articles 2 and 6-8), Title II (Article 10), Title IV (Articles 40, 52, 59, and 63), Title V (Chapter I and Articles 70 and 75), Title VI (Article 94), Title X (Articles 119-121), Supplementary Provisions - Final (Fourth and Eighth), and Annexes 1-5

Last content review/update: March 21, 2024

Overview

In accordance with the DrugAct and ClinImprtOrdr, the Thai Food and Drug Administration (Thai FDA) is responsible for overseeing the import or ordering of drugs for clinical research purposes, and also uses this authority to indirectly regulate drug clinical trials in humans. Per ClinSampleProd and DrugProdReqs, the Thai FDA is also responsible for approving requests for permission to produce drug samples for the registration of drug formulas for human research studies. As per G-ResEthics, the scope of the Thai FDA’s assessment includes Phases I through IV clinical trials for new drugs (also referred to as “modern drugs”), traditional drugs (drugs intended for use in the practice of traditional medicine or to cure animal disease), unregistered drugs, registered drugs being studied in new doses or for indications not previously approved, and locally produced drugs that require efficacy testing.

As indicated in ClinImprtOrdr, ClinSampleProd, and ECRegProc, the Thai FDA’s approvals of a drug import license and of a request for permission to produce sample drugs for human research studies are dependent upon obtaining proof of ethics committee (EC) approval to conduct the clinical trial by a Thai FDA approved EC. ClinSampleProd and ClinImprtOrdr further specify that for both types of approval requests, the application is either submitted to the Thai FDA after the research project and all of the research site(s) have been approved by an EC, or in parallel, pending review by the relevant EC.

Clinical Trial Review Process

As set forth in ClinImprtOrdr, ClinSampleProd, and G-CT-DIPApp, the Thai FDA coordinates the review of applications submitted to obtain drug import licenses for clinical research purposes (N.Y.M.1) and applications submitted to request permission to produce drug samples for human research studies (P.Y.8). Per ClinImprtOrdr and ClinSampleProd, an applicant should submit the application along with supporting documents to the Medicines Regulation Division.

Per G-CT-DIPApp, upon receipt of a drug import license application (N.Y.M.1) package, the Thai FDA’s One Stop Service & Consultation Center (OSSC) (THA-35) sends the application package to an officer in the Thai FDA’s International Affairs and Investigational Drug Section. After administrative processing and troubleshooting, the officer will send the application package to the assigned reviewer to proceed. The reviewer then receives the application package and performs a technical assessment. If the reviewer determines the package is technically correct, then it will be forwarded to the Thai FDA for approval. ClinImprtOrdr specifies that the Secretary-General is responsible for authorizing all drugs to be imported into the country. (See Submission Process and Timeline of Review sections for details on the administrative and technical processing and review timelines.)

According to the DrugAct, the Thai FDA’s approval of a drug import license application for clinical research purposes also serves as an import license that allows the sponsor to import investigational drugs into Thailand. The license will remain valid until December 31^st of the year of issue. The license holder who would like to renew the license must file an application for renewal prior to the license expiration date. (See the Manufacturing & Import section for detailed license renewal instructions).

Per G-CT-DIPApp, after the import license is granted, the applicant must inform or request permission from the Thai FDA prior to initiating the following:

Changes to clinical trial drug supplies
Changes to an approved protocol (protocol amendment) or changes related to or affecting participant safety

In cases where the sponsor is required to immediately make one (1) or more amendments because the clinical trial or the use of investigational products in the trial endangers the health of a clinical trial participant or other person, the applicant may immediately make the amendment without prior review by the Thai FDA. A corresponding notification clearly identifying the change and the rationale for immediate implementation of the change must be filed within 15 working days after the amendment implementation date. A corresponding notification letter referring to the related approved import license along with supplemental documents to be provided in the Form for Requesting Corrections/Additional Clarifications are also required (see ClinImprtOrdr (Appendix 12) and THA-18 (Appendix 12)).

Per G-CT-DIPApp, after the import license is granted, the applicant must also notify the Thai FDA of changes to the protocol that do not affect the safety of the trial participants.

No information is currently available on the review process for P.Y.8 application submissions.

Per ClinImprtOrdr and ClinSampleProd, the Ministry of Public Health (MOPH) may also establish an academic committee or subcommittee for certain drugs requiring special supervision (e.g., the Academic Subcommittee on AIDS Vaccine Trials).

As delineated in ClinImprtOrdr and ClinSampleProd, the Thai FDA has procedures to monitor the research project before, during, and after the trial ends or is terminated. ClinImprtOrdr and ClinSampleProd specify that the authorized Thai FDA officer will contact the licensee to schedule an inspection appointment and provide a letter notifying the licensee at least seven (7) days in advance, except in those cases where the Thai FDA has a special request to carry out an inspection immediately and does not notify the licensee in advance. Refer to ClinImprtOrdr and ClinSampleProd for detailed licensee information on preparing for the inspection. See also THA-18 (Appendix 11) and THA-76 (Appendix 7) for the self-examination form containing the Thai officer’s inspection summary).

Refer to the Submission Process section for submission requirements.

Appendices 1-4, 7-9, and 12

Appendices 2-4, 11-13, and 17

7

2-3 and 15

Section 4, Chapter I (10), Chapter II (12 and 17-18), and Chapter V (46)

Preface, Summary of Changes in this Edition, 1-3, and Appendices 1-4, 7-9, and 12

Preface, 1-3, and Appendices 1-5, 11-13, and 17

5 and 9-10

Appendix 12

Regulatory Fees

Last content review/update: April 24, 2024

National Institute of Health (INS)

Per Decree021-2017, the sponsor or the contract research organization (CRO) is responsible for paying a fee, as applicable, to the National Institute of Health (Instituto Nacional de Salud (INS)) to submit a clinical trial application for authorization. Additionally, per Decree021-2017, INS payment is required to modify the trial as follows: to increase the number of research sites participating in a study; to change the sponsor or the CRO under contract; to change the principal investigator; to request a time extension for the trial; to request authorization to change the trial name; or to request authorization to amend a report. Per Res0423-2019, the forms required to modify the trial may be obtained from PER-26, PER-27, PER-28, PER-43, and PER-31.

According to PER-77, the INS is revising the clinical trial application fees but in the meantime is charging the fees outlined in PER-97 and PER-112, which state that the processing fee for a clinical trial authorization is 1,775.00 Peruvian Soles. An email may be sent to consultaensayos@ins.gob.pe for any additional fee-related questions.

Pursuant to Res655-2019, which amends Decree021-2017, in the case of multicenter clinical trials, the sponsor or the CRO must submit a clinical trial application along with proof of payment information for the processing fee rather than requiring each of the participating research sites in Peru to submit their payment separately, as originally required.

Payment Instructions

As indicated in PER-112, the clinical trial application fee can be paid as follows:

Via transfer to the beneficiary account number (Código de Cuenta Interbancario (CCI)): INS 018-00000000028241304 Banco de la Nación
CURRENT ACCOUNT. 0000-282413 in the name of the INS of the Banco de la Nación
In person in the form of cash or by cashier's check

For any additional questions, send an email to Ms. Ana Rojas of the Economics Office of the National Institute of Health at arojas@ins.gob.pe.

See PER-71 for payment receipt requirements to request authorization of a clinical trial via the Virtual Submission Platform (Mesa de Partes Virtual (MPV)) (PER-106). See PER-72 for a list of trial procedures and associated payment receipt requirements, if applicable. Refer to the Submission Process section for additional information on application submission requirements.

Clinical Trial Authorization Renewal, Extension for a Clinical Trial, Addition of New Research Sites

Annex B

Preamble, Articles 1 and 3, and Annexes (4-6, 8, and 10)

Title V

Last content review/update: March 21, 2024

Thai Food and Drug Administration

In accordance with ClinDrugFees, the applicant is required to pay a fee to the Thai Food and Drug Administration (Thai FDA) to submit an application to request permission to import or order drugs for research purposes in Thailand. The ClinDrugFees states that the Thai FDA requires an administrative processing fee of 1,000 Baht to review and verify the correctness of certain application requests related to authorization, including:

Applications to request permission to import or order drugs into the Kingdom for research purposes without registering a drug formula (N.Y.M.1 form) (See ClinImprtOrdr (Appendix 2) and THA-18 (Appendix 2) for N.Y.M.1 form)
Applications for drug samples produced for research studies (P.Y.8 form) (See ClinSampleProd (Appendix 1) and THA-76 (Appendix 1) for P.Y.8 form)

In addition, per ClinDrugFees and THA-78, the Thai FDA charges the following fees for the technical evaluation of documents of any application request related to authorization:

Application for permission to import or order drugs for research purposes in the country (N.Y.M.1) or to request permission to register and produce sample drugs for human research studies (P.Y.8): 4,000 Baht
Application to expand the scope of a license to produce drug samples and register new drugs for human research studies (for drugs in bioequivalence studies): 1,000 Baht
New research drug application to expand the scope of a license to produce drug samples and register a new drug for human research studies (for drugs other than those in bioequivalence studies): 4,000 Baht
Application to amend and request specific changes related to the application requests listed in the preceding bullets: 500 Baht
Requesting a certificate of pharmaceutical product (Certificate of Pharmaceutical Product/Certificate of Free Sale): 500 Baht
Request for review of accuracy and translation of Good Manufacturing Practice (GMP) assessment report from Thai version to English version: 1,500 Baht

In addition, per ClinImprtOrdr and ClinSampleProd, in the case of the applicant designating a power of attorney to submit a paper application in person or via PDF file, the Stamp Duty fee is 30 Baht per attorney designation.

Payment Instructions

According to the Thai FDA’s One Stop Service & Consultation Center (OSSC) (THA-35) and THA-66, the OSSC’s finance section provides payment services in cases where expenses need to be paid for various submissions, and accepts multiple payment methods including the cash payment counter, cashier’s check, credit cards, and mobile banking applications for the processing of application fees. However, per THA-79, in order to submit an electronic payment using the Thai FDA’s Skynet E-Submission System (THA-54), the applicant must first submit documentation and supporting evidence to request access as required by the OSSC. Once the OSSC approves e-submission system access, the applicant can submit a payment electronically to request a drug importation waiver via THA-54. See Submission Process section for detailed submission instructions and documentation requirements to access THA-54. Refer to THA-57 for the Skynet e-submission user manual and THA-87 for a guide to request a drug importation waiver via THA-54.

Appendix 1

Appendix 2

Items 2, 11, 33, 34, and 49

1.14 and Appendices 1 and 7

1.16 and Appendices 2 and 11

Preamble and Tables 1 (Item 4.5 and Note) and 2 (Item 10)

Ethics Committee

Last content review/update: April 24, 2024

Overview

As set forth in Decree021-2017, Res655-2019 (which amends Decree021-2017), the INS-CTManual, and Res252-2022 (which amends the INS-CTManual), and PER-71, Peru requires clinical trial approval from an institutional ethics committee (EC) (El Comité Institucional de Ética en Investigación (CIEI)) that is accredited by the National Institute of Health (Instituto Nacional de Salud (INS))’s National Registry of Accredited Institutional Ethics Committees (PER-61). There are no stated requirements regarding which EC the sponsor should choose to conduct the clinical protocol review. In addition, as noted in Decree021-2017, those research institutions that do not have their own EC may select an INS-accredited EC, preferably located in the same region.

Ethics Committees for Human Subjects Health Research Other than Clinical Trials

Res233-2020, which regulates human subjects research other than clinical trials of drugs or devices, states that health institutions or entities may establish one (1) or more ECs in order to fulfill their requirements to conduct health research with human beings. Per Res233-2020, ECs that conduct health research with humans are established by statute, resolution, or other document that establishes, as a minimum, among others, the committee’s mission, its members, and their respective positions. An EC may be constituted within a public, private, or mixed health institution that provides health services and is registered with the National Registry of Institutions that Provide Health Services (Registro Nacional de Instituciones Prestadoras de Servicios de Salud (RENIPRESS)). An EC may also be an entity within the Ministry of Health of Peru (Ministerio de Salud del Perú (MINSA)), one (1) of the Peruvian universities, or a non-profit legal organization. If the entities or institutions do not have an EC, they may select another INS-registered EC to evaluate their investigations. This arrangement may occur following a written agreement between the authorities of the entities or institutions involved and the respective EC. See the Oversight of Ethics Committees section for information on registering a health service provider institution in RENIPRESS.

Institutional Research Ethics Committee of the National Institute of Health (CIEI-INS)

As described in PER-94, Peru’s Institutional Research Ethics Committee of the National Institute of Health (El Comité Institucional de Ética en Investigación del Instituto Nacional de Salud (CIEI-INS)) is an advisory committee that aims to protect the rights, life, health, privacy, dignity, and well-being of research participant(s) while adhering to the ethical principles accepted by national and international regulations, and the agreements signed by Peru on research ethics. According to PER-77, the CIEI-INS is not accredited to approve clinical trials. It approves research with human participants conducted with the involvement of the INS except for clinical trials with drugs or devices. (See PER-102 for a list of accredited ECs.)

Ethics Committee Composition

As delineated in Decree021-2017, institutional ECs must be multidisciplinary, with the participation of civil society, and be composed of at least five (5) regular members, who must ensure independence in their decision-making process.

Decree021-2017 lists the following membership requirements:

Persons with scientific expertise in the health field, including those with expertise in behavioral or social sciences
Persons with expertise in ethical matters
Persons with expertise in legal matters
Community representatives, whose primary function is to share their views on the communities where research participants are likely to come
At least one (1) full member must be from the community and not belong to the health field, or to the research institution

In addition, Decree021-2017 specifies that all members must have at least one (1) certificate of basic training in research ethics and one (1) of its members must have training in bioethics. Per Decree021-2017, the EC may consider the assistance of expert consultants on different topics, and the committee must also make the list of all members publicly accessible.

Ethics Committees for Human Subjects Health Research Other than Clinical Trials

As indicated in Res233-2020, ECs are multidisciplinary, reflecting the country’s social and cultural diversity, and must be comprised of at least five (5) members.

Res233-2020 lists the following membership requirements:

Persons with knowledge in research methodology and knowledge in the health field as well as in behavioral or social sciences
Persons with knowledge of legal and ethical matters
Community representatives; people outside the entities and institutions that comprise the ECs should also be included

In addition, Res233-2020 states that researchers must possess the relevant qualifications to carry out the investigation proposal, including basic training in ethics of research with human beings with the corresponding diplomas, certifications, titles, among others. Res233-2020 further indicates that the authorities, managers, or the main persons in charge of the entities and institutions that constitute the ECs cannot be members or preside over the members; the list of all members must be publicly accessible.

Terms of Reference, Review Procedures, and Meeting Schedule

Pursuant to Decree021-2017, for their operations, ECs must have stated rules and prepare a procedures manual that is approved by the research institution. Per Decree021-2017, the manual must provide rules and procedures for the following:

Composition and requirements that must be met by its members
Minimum EC infrastructure requirements (e.g., specific areas that allow for work performance under conditions that guarantee confidentiality; adequate computer equipment; and administrative personnel to allow an EC to function properly)
Meeting frequency
Specific quorum requirements
Administrative requirements for the presentation of files
Monitoring authorized research protocols
Preparing and approving meeting minutes
Filing related documentation
Obtaining specialist(s) advice on diseases or methodologies outside the EC’s expertise
Ensuring alternate committee members have been selected
Replacing a member with a conflict of interest
Renewal procedures

See Title IV, Chapter 7 of Decree021-2017 for detailed EC requirements.

Decree021-2017 and PER-21 further note that minimum infrastructure requirements for the operation of institutional ECs must include ensuring specific work environments that permit their work to be conducted under conditions that guarantee confidentiality, and computer equipment with sufficient capacity to handle all the information generated by the EC.

Ethics Committees Human Subjects Health Research Other than Clinical Trials

As delineated in Res233-2020, ECs must have regulations and a procedures manual approved by the entity or institution that created them, specifying procedures, internal regulations, and other operational requirements.

Res233-2020 specifies that the procedures manual must include the following:

Conditions and terms for the appointment of members
Committee structure
Member responsibilities
Submitting research projects for review
Assessing the types of review
Classifying adopted decisions and processes to communicate these decisions
Developing the mechanism for determining whether a research project requires ethical review or should be exempt
Procedures for monitoring and surveillance of investigations, from the moment approved until terminated (including presenting amendments, deviations, adverse events, etc.)
Specifying required procedures and criteria for submitting expedited reviews
Reviewing projects based on ethical criteria (i.e., scientific validity and social value of the research, favorable benefit/risk balance ratio, equitable research participant selection, adequate informed consent process, respect for people, community participation and commitment)
Independent deliberation by members (i.e., EC members, researchers, sponsors, or other agents related to the research project under review should not be present)
Adopting research projects by consensus or by vote, and always with the participation of at least one (1) community representative and/or a member external to the entity or institution that constituted the EC
Requesting external assistance from independent consultants when necessary, taking into account the specialty or complexity of research under review

See Chapter 7 of Res233-2020 for detailed EC requirements.

Res233-2020 further notes that the entities and institutions that constitute the ECs must provide all of the economic, human, logistical, infrastructure, or the availability of other resources necessary for its operation.

7.4 and Annexes 1 and 4 (Flowchart 03)

I, VII (7.1 and 7.2), and VIII (8.2 and 8.3)

Annex B

Requirements for Initiating the Procedure (3) and Annex 3

Title IV (Article 40 and Chapter VII), Title V (Article 67), and Supplementary Provisions—Final (Eighth)

Last content review/update: March 21, 2024

New Info (Not Yet in Profile)

Version 5.1 of the CREC’s Standard Operating Procedures for the Operations of the CREC and Office Staff took effect on July 24, 2024 and replaces THA-37. (Google Translation of SOPs)

Overview

As per ClinImprtOrdr, ClinSampleProd, and ECRegProc, clinical trials require ethics committee (EC) approval for each trial site from an EC recognized by the Thai Food and Drug Administration (Thai FDA). ECRegProc indicates that an EC may function as a committee under a government agency (e.g., the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH)); as a committee affiliated with a private hospital/institution licensed to comply with the HospitalAct; or, as a committee operating as a part of a non-profit partnership between a government agency and a private organization(s) (e.g., the Central Research Ethics Committee (CREC)). ECRegProc states that the Thai FDA posts a list of the approved/renewed ECs on its website (see THA-90), and as noted in THA-3, this usually occurs every two (2) years. According to THA-4, the ECMOPH and the CREC are both government ECs whose approvals are still active. As discussed in THA-63, the ECMOPH and the CREC are also collaborating on a multi-institutional clinical research project to reduce redundancy during the review process and to develop joint human research ethics guidelines. (See THA-18 and THA-76 for the forms included in the appendices in ClinSampleProd and ClinImprtOrdr.) (Note: The ECMOPH website is not accessible to users residing outside of Thailand.)

Per THA-1, the ECMOPH and the CREC represent the two (2) central ECs recognized by the Thai FDA to review and approve clinical research protocols involving humans. THA-1 further explains that both the ECMOPH and the CREC are categorized as central ECs because they can accept all clinical research studies for review, regardless of the trial sites involved.

Ethical Review Committee for Research in Human Subjects, Ministry of Public Health

Per THA-39, the ECMOPH is responsible for controlling, supervising, and monitoring research in accordance with international ethical principles; developing research policies; suspending unethical research programs; creating a national database of clinical research; establishing a regional/international committee network system; developing personnel capacity to support clinical research in Thailand; and other related or assigned academic projects. See THA-13 for additional details about the ECMOPH, and THA-13 and THA-39 for requirements specifically related to studies approved by the ECMOPH.

Central Research Ethics Committee

Per THA-1, the CREC was formed in 2014 through the cooperative efforts of 26 public and private institutions in Thailand, including the Thai FDA. THA-44 explains that the focus of the CREC is on reviewing multi-center clinical research projects to improve the efficiency of the EC review and to reduce the duplicative review of multi-institutional studies. See THA-44 for additional information on the CREC, and the Submission Process and Submission Content sections for detailed CREC submission requirements.

Ethics Committee Composition

As per G-ResEthics, institutional ECs should consist of at least five (5) members, both male and female, with the following qualifications:

At least one (1) member with knowledge and experience in research fields regularly reviewed (e.g., medicine, public health, social science, etc.)
At least one (1) member who is a lawyer or has legal expertise
At least one (1) member who is unaffiliated with the institution, and, if possible, that member should be selected from the community where the institution is based
At least two (2) members who have patient care, counseling, and treatment knowledge and experience
At least one-third of the total EC should be knowledgeable or trained in human research ethics

ECRegProc, by comparison, also requires institutional ECs to have at least five (5) members who are experts on science, medicine, and ethics. In addition, the committee must include members representing the following qualifications:

At least three (3) members who are medical professionals
At least one (1) member must be an expert in a non-scientific category
At least one (1) member from outside of the institution where the trial is taking place

The International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (THA-28) similarly indicates that ECs should be composed of medical personnel, scientists, and non-scientists, and also notes that while these committees may have differences in legal status, composition, and function, the duties of an EC should be consistent with THA-28. Per an in-country subject matter expert, Thailand is implementing THA-28.

Because each EC has its own requirements, it is recommended that the individual ECs be contacted to confirm their specific requirements.

No information is available on ECMOPH and CREC composition requirements.

Terms of Reference, Review Procedures, and Meeting Schedule

As delineated in G-ResEthics and ECRegProc, ECs must conduct clinical protocol reviews according to THA-28 using written standard operating procedures (SOPs) that are periodically updated, and develop a process for conducting reviews. The SOPs should include information on EC composition, meeting schedules, timeframes for protocol reviews, quorum requirements, decision-making procedures, channels of communicating the decision(s), complaint processes, reviewing fees (if any), protection of protocol confidentiality, and prevention of possible conflicts of interests. The G-ResEthics also states that each EC must establish the composition, member terms of service, and criteria for selecting the committee members, as appropriate. The members must also be appointed officially as evidenced by a written document.

Additionally, per ECRegProc, ECs must meet the following requirements:

Have the legal qualifications or comply with the government regulations related to providing research or research-related services
Have a clearly defined structure with proof of appropriately appointed members, including the secretary and secretariat
Have voting rights and the right to issue independent research opinions without investigator/sponsor involvement, and with no direct or indirect interest or conflict of interest with the investigator or clinical research study
Have members who are trained in conducting research and clinical trials in human participants, and who participate in ethics training or other related training at least once every two (2) years while serving on the committee
Have experience in reviewing human research involving experimental drugs for at least 10 studies

For detailed EC requirements and information on other administrative processes, see G-ResEthics and ECRegProc.

Also, refer to THA-47 for a list of CREC forms needed to prepare for initial protocol submission, and THA-37 for a complete list of CREC SOPs.

No information is available on the ECMOPH’s terms of reference, review procedures, and meeting schedule.

Which EC? And CREC

Important Modifications in the New List

Important Updates in the New List and Saving Time…and Cost!

Appendices 3-4, 7, and 9

Appendices 1-5, 11, and 13

1.27 and 3.3

Chapter 6

Preface, 1, 3, and Appendices 3-4, 7, and 9

1, 3, and Appendices 1-5, 11, and 13

4-6 and 9-10

Scope of Review

Last content review/update: April 24, 2024

Overview

According to Decree021-2017 and the G-EC-CTRev, the primary scope of information assessed by institutional ethics committees (ECs) (Comités Institucional de Ética en Investigación (CIEIs)) relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. The EC scope also aligns with the principles delineated in the PeruConstitution and Decree011-2011, which assert that the defense of the human person and respect for their dignity are the supreme goal of society and the state.

As per Decree021-2017, Decree011-2011, and the G-EC-CTRev, ECs must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable. Per Decree021-2017, when a clinical trial is proposed for subordinate groups (e.g., students, health workers, employees, military members, police, prisoners, etc.), one (1) or more members of the population under study, or another person within this community capable of guarding the conditions and human rights that correspond to the group in question, should participate in the EC review. (See the Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; and Mentally Impaired sections for additional information about these populations).

Decree021-2017 and the G-EC-CTRev also state that the National Institute of Health (Instituto Nacional de Salud (INS))-registered and accredited ECs are responsible for ensuring an independent, timely, and competent review of all ethical aspects of the clinical trial protocol. They must act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants; confirming the suitability of the investigator(s), facilities, and methods; and verifying the adequacy of confidentiality and privacy safeguards.

Res686-2020, in turn, states that in the ethical review of clinical studies of vaccines in humans, ECs must comply with the ethical criteria delineated in Res233-2020. Additionally, in all deliberations, ECs must ensure the following ethical criteria are present: social value and scientific validity of the research; favorable benefit/risk balance and risk minimization; fair selection of research subjects; informed consent process; respect for people; and community participation and commitment. Therefore, per Res686-2020, an EC decision regarding the approval or disapproval of a vaccine clinical study protocol must have a solid and justified ethical basis in the Council for International Organizations of Medical Sciences (CIOMS) criteria (PER-78).

Ethics Committees for Human Subjects Health Research Other than Clinical Trials

Res233-2020, which regulates human subjects research other than clinical trials of drugs or devices, similarly states that the focus of ECs that conduct human health research is to ensure the protection of the rights, safety, and well-being of the research participants. In addition, the INS must ensure the governance of all health research involving human beings is conducted ethically; the scientific validity and social value of the research is considered by the research studies; the equitable selection of research participants; the adequacy of the informed consent process; respect for the participants; and the participation and commitment of the communities. Res233-2020 further specifies that human studies include, but are not limited to, epidemiological research, genetic research, social science research, research on medical records, and research on stored samples, among others.

Per Res233-2020, the ECs are also responsible for conducting rigorous, timely, and competent ethical reviews of research projects based on the CIOMS' International Guidelines for Health-Related Research Involving Humans (PER-78). Furthermore, the ECs should monitor the progress of an approved research project until it has concluded.

Additionally, per Res233-2020, the research entities or institutions that constitute ECs conducting human health research must have policies of scientific integrity in accordance with international standards on the matter and the National Code of Scientific Integrity (PER-79), which includes appropriate investigation and sanction procedures.

Role in Clinical Trial Approval Process

As per Decree021-2017, Res655-2019 (which amends Decree021-2017), the INS-CTManual, Res252-2022 (which amends the INS-CTManual), and the G-EC-CTRev, an INS-accredited EC must provide written confirmation of review and approval of the clinical trial protocol and the informed consent form (ICF) prior to the sponsor or the contract research organization (CRO) submitting the clinical trial application to the INS. Therefore, the INS and EC reviews may not be conducted in parallel.

According to Decree021-2017, each institutional EC determines its own review and approval timeline and continuing review requirements based on its internal regulations and standard operating procedures.

Per Decree028-2023 (which amends Decree021-2017), a minor change(s) to the protocol and/or ICF only requires the approval of the INS registered and accredited EC that originally approved the current version, and the sponsor must communicate the change(s) in writing to the INS’s DIIS prior to its implementation. Decree028-2023 and Res184-2023 (which amends Decree021-2017) also note that a minor change does not generate a new version of the protocol or ICF; however, if a subsequent amendment is made to the protocol, it must also contain the minor change(s) made. (See Timeline of Review section for timeline information on submitting minor changes to the INS’s DIIS.)

Res184-2023 specifically lists the following as minor changes to the protocol and/or ICF:

Typographical error corrections - A material unintentional error in a word, term, or expression that results from the writing, transcription, or translation of a specific expression that does not alter the meaning, objective, or intent of the word, term, or expression.
Modification of the conditions of clinical trial authorization or amendments - Updates made to the approved protocol and/or ICF, as a result of procedures for clinical trial modifications or amendments, linked to the change of protocol title, and/or name of the principal investigator, sponsor, and/or CRO; and/or study completion date, provided that the change is previously authorized by Director's Resolution or Official Letter issued by the INS's DIIS, as a result of the corresponding administrative procedure.
Clarifications and/or modifications of an administrative or operational aspect - Changes made to the approved protocol and/or ICF for strictly administrative or operational reasons. In addition, a clarification refers to a clarification of the protocol and/or ICF information or content which does not alter the meaning, objective, or intention of the document.

See Res184-2023 for detailed descriptions of minor changes to the protocol and/or ICF.

Per Decree021-2017, ECs must also conduct regular monitoring, with a frequency based on the degree of risk to participants, but no less than once a year. Further, they must suspend or cancel the trial when participants are exposed to uncontrolled risk and inform the research institution, the sponsor and/or the CRO, and the INS’s Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) (formerly known as the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT))) of the suspension or cancellation.

(See the Submission Process and Timeline of Review sections for detailed submission process and timeline details.)

Preamble, VII, Ethical Criterion 1, Ethical Criterion 5, and Annex 3

Annexes 1 and 3

Chapter 1 (Articles 1 and 2) and Chapter 2 (Article 7)

Preface, Articles 1-2, and Annex 1

I, VII (7.1-7.3), and VIII (8.2 and 8.3)

Annex B

4 and 5.2

Preface, Article 1 (Articles 2 (10) and 40), and Article 2 (Articles 2 (48), 6, and 85-A)

Requirements for Initiating the Procedure (3) and Annex 3

Preamble, Introduction, II (1 and 3), and V (1)

Title I (Article 4), Title II (Article 9), Title III (Article 24), Title IV (Articles 58-60 and 64-67), and Title V (Article 70)

Last content review/update: March 21, 2024

Overview

As delineated in G-ResEthics, ECRegProc, and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (THA-28), the primary scope of information assessed by Thai Food and Drug Administration (Thai FDA) recognized ethics committees (ECs) relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. According to THA-10, clinical research and trials (i.e., research studies and experiments on humans) are subject to the medical ethics standards delineated in the Regulations of the Medical Council on Maintaining the Ethics of the Medical Profession (B.E. 2549) (MCEthics), the Declaration of Rights and Code of Conduct for Patients (THA-11), and the Researcher’s Code of Ethics (THA-14).

MCEthics explains that ECs are established to review the ethical aspects of research studies and human trials to protect the rights, safety, and well-being of participants in research studies and human trials. THA-14 further states that researchers should treat all research participants, whether animate or inanimate, with appropriate respect and consideration and should take full responsibility for the impact and consequences of their research. Researchers should also have respect for the dignity and rights of their human participants. THA-11 indicates that every patient has the fundamental right to receive professional medical and health care from health professionals without discrimination as provided for in the Constitution of the Kingdom of Thailand (B.E. 2560). Per G-ResEthics, ECRegProc, and THA-28, ECs must also pay special attention to reviewing informed consent and protecting the welfare of certain classes of participants deemed to be vulnerable. Per an in-country subject matter expert, Thailand is implementing THA-28. (See the Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses, and Neonates; Prisoners; and Mentally Impaired sections for additional information about these populations).

In addition, per G-ResEthics, ECRegProc, and THA-28, ECs are also responsible for ensuring an independent, timely, and competent review of all ethical aspects of the clinical trial protocol. ECs must act in the interests of the potential research participants and the communities involved, evaluating the possible risks and expected benefits to participants; confirming the suitability of the investigator(s), facilities, and methods; and verifying the adequacy of confidentiality and privacy safeguards. G-ResEthics further states that ECs should review the ethical aspects of the protocol in compliance with current international ethical guidelines while taking into account local or national laws, religions, traditions, and cultures. Per G-ResEthics, the appointed EC is also responsible for ensuring that research conducted within the institution adheres to ethical principles including those established in the Declaration of Helsinki (THA-45), the Council for International Organizations of Medical Science (CIOMS)’ International Ethical Guidelines for Biomedical Research Involving Human Subjects (THA-7), and the World Health Organization (WHO)’s Operational Guidelines for Ethics Committees that Review Biomedical Research (THA-64). See G-ResEthics, ECRegProc, and THA-28 for detailed ethical review guidelines. MCEthics further states that the medical practitioner who conducts or participates in the research study on humans must only undertake such study or experiment after it is approved by the EC responsible for the study. The medical practitioner must also conform to G-ResEthics and THA-14 when conducting the research study.

Role in Clinical Trial Approval Process

Pursuant to ClinImprtOrdr and ECRegProc, Thai FDA-recognized ECs are responsible for reviewing and approving protocols for clinical research related to drugs to be imported into Thailand. Per ClinSampleProd and DrugProdReqs, the Thai FDA is also responsible for approving requests for permission to produce drug samples for the registration of drug formulas for human research studies. As stated in ClinImprtOrdr, ClinSampleProd, and ECRegProc, the Thai FDA’s approvals of a drug import license and of a request for permission to produce sample drugs for human research studies are dependent upon obtaining approval by a Thai FDA approved EC. ClinImprtOrdr and ClinSampleProd further specify that for both types of approval requests, the application is either submitted to the Thai FDA after the research project and all the research sites have been approved by an EC, or in parallel, pending review by at least one (1) EC involved in the study. THA-5 further notes that if an approval is obtained from the EC of the research institute or university conducting the trial, an approval from the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH) is usually optional (unless it is further required by the internal rules and regulations of that research facility).

In the instance of a multicenter clinical trial, G-ResEthics indicates that protocols submitted to each institution’s EC should contain the same content substance and details, and should specify the quality control techniques to ensure that research practices are the same in each institution. Although each institutional EC may independently approve or disapprove an application, G-ResEthics advises the committees from each participating institution to consult with one another to reach a clearly agreed upon decision.

There is no stated expiration date for an EC approval in G-ResEthics, in the ECMOPH guidelines (THA-13), or on the Central Research Ethics Committee (CREC) website (THA-36). Per ECRegProc, ECs must provide continuous supervision and monitoring, and conduct inspections to ensure that clinical trial operations are carried out in compliance with all approved research projects and research sites without any deviations or changes from those approved by the committee, unless otherwise specified according to THA-28. ECs must also supervise and monitor research projects to ensure that participants’ rights, safety, and well-being are protected (e.g., in the case of an adverse event, etc.).

Ethical Review Committee for Research in Human Subjects, Ministry of Public Health

According to THA-13, an application submitted to the ECMOPH is initially reviewed by at least two (2) advisors, followed by a final review by the ECMOPH at its regular meeting. At this meeting, the advisors present a summary of the proposal to the committee along with their recommendations. The committee discusses the proposal and sends a list of comments to the principal investigator (PI) for clarification. Once the PI provides the requested information, the committee makes a final decision, and this is reported to the ECMOPH Chairman and the Permanent Secretary for Public Health respectively. A letter of notification signed by the Permanent Secretary for Public Health is then forwarded to the PI and the responsible organization. As earlier stated, this review and approval process is specific to the ECMOPH. However, it can be used to obtain a better understanding of the EC process within Thailand.

Central Research Ethics Committee

As indicated in THA-44 and THA-24, a research project is eligible to apply for CREC review when it meets one (1) of the following criteria:

It is a pharmaceutical-sponsored multi-center clinical trial
It is an investigator-initiated multi-site study granted by a research funding organization (e.g., the National Research Council of Thailand (NRCT), the Thai Health Promotion Foundation, the Health Systems Research Institute (HSRI), etc.)
It is assigned by the Thai Health Board of Directors for review
It is a single center, multi-site study of researchers at partner institutions with co-researchers from each site (THA-24)

Per THA-44, when a research proposal is submitted to the CREC for review, the committee will cooperate with all the participating ECs to confirm the researchers are qualified, the institution has adequate facilities, and the proposed research is compliant with institutional regulations, applicable laws, local contexts, and standards of professional conduct and practice. The CREC will also consider the concerns and attitudes of the various communities participating in the project. Once the review process is completed, the decision will be documented in a formal letter. The issued decision letter will be sent to the PI, the contract research organization, and all of the participating ECs. Refer to THA-44 and THA-24 for additional CREC requirements.

Clinical Trials

2

Instruction for the Submission of a Study/Research Proposal to be Reviewed by the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (p.63)

4-5

1.27 and 3.3

1.1, and Chapters 2, 4, and 6

Preface, Summary of Changes in this Edition, 1, 3, and Appendices 3-4, and 9

1, 3, and Appendices 1-5 and 13

Chapter 1 (Article 5) and Chapter 9 (Articles 50-51)

5-6

Appendix 12

Ethics Committee Fees

Last content review/update: April 24, 2024

Fees are determined by each accredited institutional ethics committee.

Last content review/update: March 21, 2024

As explained in G-ResEthics, Thai Food and Drug Administration (Thai FDA)-recognized ethics committees (ECs) should review their research budgets to ensure that fee information is addressed. In general, the sponsor will pay the investigator based on the number of research participants. The Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH) and the Central Research Ethics Committee (CREC) are both ECs recognized by the Thai FDA to review and approve clinical trial protocols.

G-ResEthics further states that research conducted in public hospitals or public health care facilities involves expenditures such as laboratory tests and lump sum fees determined by the institution. The disclosure of these payments and other budget items enables the EC to evaluate any conflict of interest and helps the investigator to decide whether to conduct the trial.

Ethical Review Committee for Research in Human Subjects, Ministry of Public Health

No information is currently available on ECMOPH fees.

Central Research Ethics Committee

As set forth in CRECFees, the CREC requires investigators to pay a nonrefundable fee to submit a clinical trial research protocol for ethical review and approval.

CRECFees and THA-50 specify the following fees for the ethical review of research projects funded by private capital (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

New research project: 50,000 Baht

· Request for certification renewal of old research project: 20,000 Baht

Amendments to the research project (research outline amendments/adding a research location): 10,000 Baht
Report requesting amendments to the research outline: Amendment certified by the local EC of the joint research institute in the CREC-certified research project, followed by a report submitted for CREC consideration (site-specific amendment): No fees charged
Reporting adverse events, reporting non-compliance, notifying the CREC of a research project closure, and various other reports: No fees charged
Edit the Certificate of Approval (COA) document: 1,000 Baht
Edit certification/acknowledgement: 500 Baht
Edit document with certified seal: 500 Baht

For research projects funded by government agencies, royal colleges, medical professional associations, or personal capital, CRECFees and THA-50 delineates the following fees:

New research project: 25,000 Baht
Request for certification renewal of old research project: 10,000 Baht
Amendments to the research project (research outline amendments/adding a research location): 5,000 Baht
Report requesting amendments to the research outline: Amendment certified by the local EC of the joint research institute in the CREC-certified research project, followed by a report submitted for CREC consideration (site-specific amendment): No fees charged
Reporting adverse events, reporting non-compliance, notifying the CREC of a research project closure, and various other reports: No fees charged
Edit the Certificate of Approval (COA) document: 500 Baht
Edit the certification/acknowledgement: 250 Baht
Edit document with certified seal: 250 Baht

Payment Instructions

THA-42 explains that investigators should submit ethics application fee payments to the following bank:

Bank Name: Krungthai Bank
Bank Address: 2/1 SOI Phahonyothin, Phahonyothin Road 40, Sena Nikhom, Jatujak, Bangkok 10900
Swift Code: KRTHTHBK
Branch: Phahonyothin 39
Account Type: Savings Account
Account Name: Foundation for Human Research Promotion in Thailand
Account number: 981-2-84782-0

Per CRECFees and THA-25, the investigators must submit proof of payment with the application submission. CRECFees indicates that the investigators and research sponsor are responsible for paying the fees and preparing the documentation to submit to the research institute. In the case of an investigator having transferred fees for a project that has been cancelled, the investigator may request a refund. The Foundation will deduct 20% of the transferred fee. The investigator should contact the bank for any service fee applied.

THA-50 and THA-25 indicate that any questions regarding the payment submission process may be directed to the following contact:

Miss Netdao Kanseecha
Financial Officer
Phone: 061-089-9966
Email: natdown@crecthailand.org

Per THA-25, if the CREC has no evidence of payment, the application submission will be considered incomplete. See THA-50 for additional information on fee rate based on funding source and fee receipts.

Type of Funding Source, Fee Rate, and Notes

7.1.5

Oversight of Ethics Committees

Last content review/update: April 24, 2024

Overview

As set forth in Decree021-2017, the INS-CTManual, and PER-61, the National Institute of Health (Instituto Nacional de Salud (INS))’s Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) (formerly known as the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT))) is responsible for registering and accrediting institutional ethics committees (ECs) (Comités Institucional de Ética en Investigación (CIEIs)) listed in the INS’s Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) (PER-89) (also referred to as REPECv2) to review and approve clinical trials. The DIIS must evaluate and verify EC compliance with the registration and accreditation standards established in the INS-CTManual. Per Decree021-2017, the INS-CTManual, PER-71, and PER-61, Peru requires clinical trial approval from an EC that is accredited by the INS’s National Registry of Accredited Institutional Ethics Committees (PER-61). (See PER-102 for a list of accredited ECs.)

Ethics Committees for Human Subjects Health Research Other than Clinical Trials

As delineated in Res233-2020, the INS is also responsible for providing advice, guidance, and technical assistance to all ECs and their entities or institutions that review health research with human beings; organizing training and education activities for EC members and researchers; promoting integration and cooperation networks among participating ECs; promoting relations between the ECs and different entities linked to the research ethics field; providing access to international resources to strengthen research ethics; establishing flexible review procedures and mechanisms appropriate for an expedited and rigorous ethical review of human health research in disaster situations and disease outbreaks; and assigning the INS’s DIIS to disseminate information and supervising ECs at the national level per the ethical research guidelines delineated in Res233-2020.

Registration, Auditing, and Accreditation

Per Decree021-2017, each research institution may establish an EC and register it with the INS via PER-89. (Refer to PER-102 for instructions on registering in the REPEC system.)

Per Decree021-2017, Res233-2020, the INS-CTManual, and the G-ECRegProcs, INS-registered ECs are only required to obtain accreditation if they are conducting a review of a clinical trial protocol involving pharmaceutical products. In addition to completing the accreditation/renewal application form (see PER-85 for FOR-OGITT-025), the applicant should complete the affidavit form (see PER-21 for FOR-OGITT-026) to demonstrate compliance with the accreditation standards delineated in the INS-CTManual. Both forms must be electronically submitted via PER-89. See PER-81 for instructional videos on registering on the REPEC platform.

PER-61 explains that once the registration form is electronically submitted, the user will receive a temporary EC registration number. Both the affidavit form and the registration forms should be printed and signed, and then attached along with the other accreditation documents required to be sent to the DIIS via the Document Processing Office located in the INS headquarters (refer to PER-61 and PER-98 for detailed requirements and instructions).

Decree021-2017 and the INS-CTManual state that accreditation is temporary and must be renewed every three (3) years. Per Decree021-2017, Res655-2019 (which amends Decree021-2017), and the INS-CTManual, the following accreditation requirements must be completed:

EC accreditation application sent to INS (PER-85), per Res0423-2019
Copy of the resolution/decision issued by the highest authority of the research institution authorizing EC operation
Copy of institutionally approved EC regulations and its Manual of Procedures submitted in electronic form (editable PDF)
Affidavit of compliance with INS-CTManual accreditation standards (PER-21), per Res0423-2019
Curriculum vitaes signed by each EC member submitted in electronic form (editable PDF)

Per the INS-CTManual, it is recommended that applications for EC accreditation renewals be submitted 30 calendar days before the end of term. Additionally, the INS-CTManual provides detailed information on the inspections that the INS-accredited ECs may be subject to before, during, and after EC registration.

Refer to the INS-CTManual and PER-61 for detailed submission instructions, and PER-85, PER-21, PER-22, and PER-35 for the EC accreditation application and EC affidavit of compliance forms.

Ethics Committees for Human Subjects Health Research Other than Clinical Trials

Res233-2020, which regulates human subjects research other than clinical trials of drugs or devices, requires ECs to be registered with the INS via the National Registry of Research Ethics Committees (Registro Nacional de Comités de Ética en Investigación), per the G-ECRegProcs. The G-ECRegProcs establishes standardized procedures for the INS’s DIIS to conduct EC registration evaluation in compliance with Res233-2020. As specified in the G-ECRegProcs, the DIIS’s Clinical Trials Subdirectorate (Subdirección de Ensayos Clínicos) (formerly known as the Executive Office of Investigation (Oficina Ejecutiva de Investigación (OEI)) is responsible for receiving, evaluating, and responding to EC registration requests. Depending on the implementation period, registration can be immediate, in which registration occurs at the time of the request, or progressive, in which implementation is carried out over a maximum period of two (2) years after initial EC registration. During the implementation of progressive requirements, the DIIS can provide advice and guidance to the EC upon request.

Per the G-ECRegProcs, in the case of immediate registration approval, once the registration application file is initially reviewed for completeness, it is forwarded to the application evaluator who verifies whether the file minimally complies with all the immediate requirements within 30 days. If the registration file meets the immediate requirements and the information provided complies with the INS-CTManual and the G-ECRegProcs provisions, the evaluator prepares a favorable response report and a draft record of registration, addressed to the Clinical Trials Subdirectorate. Once the favorable response report has been received, the Clinical Trials Subdirectorate evaluates and endorses it, sending the report and draft record of registration to the DIIS. The DIIS issues the EC certificate of registration and incorporates registration into the National Registry of Research Ethics Committees (Registro Nacional de Comités de Ética en Investigación) database. In addition, per the G-ECRegProcs, an EC registration may be suspended if the EC has not completed implementation of the progressive registration requirements within the two-year term. Refer to G-ECRegProcs for additional information on the DIIS’s registration review and approval process.

Chapter VII (7.3-7.4 and 7.9) and Annex 4 (Flowcharts No. 02-03 and 17)

I, VII (7.4) and VIII (8.1 and 8.2)

Annex B

Preamble, Article 1, and Annexes (2-3)

Title IV (Articles 54, 58, and 63), Title V (Article 67), Title VII (Article 102), and Supplementary Provisions—Final (Eighth)

Last content review/update: March 21, 2024

Overview

As indicated in ECRegProc, ClinImprtOrdr, and ClinSampleProd, institutional ethics committees (ECs) and other types of ECs, including the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH) and the Central Research Ethics Committee (CREC), must be authorized by the Thai Food and Drug Administration (Thai FDA) to conduct ethical reviews of drug clinical trial protocols. ClinImprtOrdr and ECRegProc specify that authorized ECs are responsible for reviewing and approving protocols for clinical research involving drugs to be imported into Thailand. (See also THA-18 and THA-76 for the forms included in the appendices relating to EC authorization in ClinImprtOrdr and ClinSampleProd.)

As per ECRegProc, an acceptance letter issued to the ECs by the Thai FDA is valid for two (2) years and may be obtained by applying to the agency using the Jor Thor Form EC-1 (THA-23). Each EC is also required to submit an annual report (THA-21) to the Thai FDA, and to apply for an acceptance extension no later than 60 days before the expiration date.

ECRegProc states that the Thai FDA posts a list of the approved/renewed ECs on its website (see THA-90) and as noted in THA-3, this usually occurs every two (2) years. These ECs are approved in addition to the centralized ECMOPH and the CREC.

Registration, Auditing, and Accreditation

Pursuant to EC-QualAccredReq, in addition to the ECRegProc approval and renewal of approval documentation requirements, the Thai FDA requires ECs to submit proof of accreditation based on an evaluation by a quality accreditation agency in compliance with international accreditation standards. The following organizations are approved by the Thai FDA to provide quality accreditation reviews:

National Ethics Committee Accreditation System of Thailand (NECAST)
The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER)/The Forum for Ethical Review Committees in Asian and Western Pacific Region (FERCAP)
The Association for the Accreditation of Human Research Protection Programs (AAHRPP)
Other Thai FDA-approved quality accreditation agencies

Per EC-QualAccredReq, EC submissions will be reviewed and completed within one (1) business day.

Important Modifications in the New List

Appendices 3-4 and 9

Appendices 2-5 and 13

Preface, 1, 3, and Appendices 3-4 and 9

1 and Appendices 1-5, and 13

Preface, 4-6, 9, and 11

Submission Process

Last content review/update: April 24, 2024

Overview

In accordance with Decree021-2017, Res655-2019 (which amends Decree021-2017), the INS-CTManual, and Res252-2022 (which amends the INS-CTManual), the sponsor or the contract research organization (CRO) is responsible for submitting a clinical trial application to the National Institute of Health (Instituto Nacional de Salud (INS)) to obtain approval to conduct a clinical trial in Peru. Per Decree021-2017, Res655-2019, the INS-CTManual, Res252-2022, and the G-EC-CTRev, the INS-accredited ethics committee (EC) must first approve the research protocol and informed consent form (ICF), and the sponsor or the CRO must submit this information as part of the application dossier in order for the INS to conduct its review. Therefore, the INS and EC reviews may not be conducted in parallel. Decree021-2017 also states that sponsors not based in Peru are required to appoint a legal representative in the country who coordinates all communication with the INS’s Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) (formerly known as the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT))) for the trial’s duration, unless such responsibility is delegated to a CRO.

Regulatory Submission

REPEC Pre-Submission Registrations

As delineated in Decree021-2017, Res655-2019, Res252-2022, the INS-CTManual, PER-60, and PER-59, prior to submitting an application for clinical trial authorization, the sponsor and the CRO must register with the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) (PER-89) (also referred to as REPECv2). The INS-CTManual also notes that the sponsor registration application (PER-36) must be submitted in Spanish or accompanied by a proper translation if issued in a language other than Spanish. See the INS-CTManual, PER-60, and PER-59 for detailed sponsor and CRO registration instructions and PER-36 and PER-37 for the sponsor and the CRO registration forms. Refer to Res393-2021 for additional information on the updated sponsor registration form (PER-36). See also PER-81 for instructional videos on registering with PER-89.

Additionally, as specified in PER-89, the REPECv2 platform should be used to obtain information or request feedback on procedures and operations related to a newly submitted clinical trial, to track the status of the authorization process, to identify critical events that require immediate attention via an alert system (e.g., expiring or expired authorizations and necessary notifications per Decree021-2017), and to obtain updated information on clinical trials being conducted in Peru. Also, as explained in PER-114, DIIS has initiated the process of migrating information from the older platform (REPECv1) (PER-91) to PER-89 to receive and manage clinical trial information on a single platform, therefore all new requests for clinical trial procedures should be entered through PER-89. However, per PER-88, any requests for procedures related to an already active clinical trial must still be requested using the older REPEC platform via PER-91. PER-114 further notes that requests for clinical trials that are in progress and have been entered through REPECv1 will not be migrated to REPECv2 until the procedure is concluded.

Submissions

Pursuant to Res252-2022, all application related documents must be electronically submitted through the Virtual Submission Platform (Mesa de Partes Virtual (MPV)) (PER-106). According to PER-103, all notifications relating to procedures submitted via PER-106 will only be responded to in the PER-106 notification mailbox; notifications will not be communicated via email or other forms of communication.

Per PER-104, users must also be registered on PER-106 prior to submitting any application related documents. Registration is done through PER-106 or via the MPV link on the INS webpage. Although, as indicated in PER-106, non-citizens cannot register directly with PER-106, and require an in-country representative to provide proof of citizenship to register using either a national identity document or an immigration card. Refer to the G-MPVManual and the G-VirtSubPlatfrm for detailed user instructions and procedures, and PER-107, PER-110, and PER-105 for additional information on the MPV system.

As explained in Decree021-2017, the INS-CTManual, Res252-2022, and PER-71, once the sponsor or the CRO is registered in the REPEC and MPV systems, a request for clinical trial authorization must be submitted electronically via PER-89. (See PER-24 for the clinical trial application form and PER-10 for instructions on completing the form.) Per Res252-2022, the completed electronic request form should then be submitted via PER-106 along with the required documentation as set forth in Decree021-2017 and Res655-2019.

Decree021-2017 and Res655-2019 further indicate that the clinical trial application and accompanying material (including the updated Investigator’s Brochure (IB)) must be provided in Spanish. Any document not in Spanish must be submitted with a corresponding translation. Decree021-2017 also states that if the protocol title is written in English, a single title in Spanish must be assigned for all purposes. In addition, the research protocol and the ICF must also be in Spanish and in the original language, if different from Spanish, and include a copy of the approval by an INS-accredited EC. Per Decree021-2017, research and complementary investigational product (IP) media labeling must also be printed in indelible ink in Spanish or English. The INS-CTManual also notes that notification reports for IPs should contain a translated summary in English and Spanish.

For amended protocols or ICF submissions, Res655-2019 states that any changes should be electronically submitted (editable PDF) with track changes in Spanish and in the original language. The final protocol and ICF should include all of the incorporated amendments in an editable PDF file and comply with all of the previously discussed protocol submission requirements. See also Res655-2019, PER-32, PER-33, PER-34, and PER-35, for additional details on submitting protocol amendments and the related forms. See PER-105 and G-MPVManual for information on submitting documents electronically via PER-106 or via the MPV link on the INS webpage.

PER-92 indicates that for questions or problems with PER-89, contact:

Jenny Parillo, Engineer
Phone: (511) 748 0000 Extension: 2616 or 984108368 (Cell)
Email: jparillo@ins.gob.pe

(Note: Application submission instructions in earlier sources including Res655-2019, the INS-CTManual, and PER-71, do not reflect this new electronic submission option.)

For reference, the following are applications and forms that may be used to submit various procedures via PER-106:

PER-24 for the clinical trial application for authorization
PER-26 for the application to extend the number of research sites
PER-28 for the application to change the principal investigator (PI)
PER-29 for the application to change the sponsor/CRO
PER-31 for the application to cancel a clinical trial
PER-35 for the affidavit to be signed by the principal investigator (PI) and sponsor on the research site’s preparedness for the clinical trial
PER-43 for the application to close a clinical trial research site
PER-44 for the affidavit of compliance with minimum research site requirements
PER-50 for the research team curriculum vitae form
PER-85 for the EC accreditation/accreditation renewal form
PER-87 for the form and requirements to request INS approval to supervise a clinical trial virtually

Refer to the INS-CTManual, Res252-2022, and PER-71 for additional submission information. See PER-6 for a flowchart delineating the clinical trial authorization process. See also the Submission Content section for detailed documentation requirements.

Ethics Review Submission

Because the submission process at individual institutional ECs will vary, applicants should review and follow their institution’s specific requirements.

Annex 3

Chapter VII (7.1-7.2 and 7.8.2-7.8.3) and Annexes 1, 3, and 4 (Flowcharts No. 04, No. 13, and No. 14)

Annexes A and B

Requirements for Initiating the Procedure (3), 1.1-1.4, 2.3, 4.1-4.4, 7.1-7.2, and Annexes 1-3

Title I (Articles 6-7), Title III (Article 34), Title IV (Articles 39-40, 59, and 63), Title V (Articles 67, 75, 80, and 88), Title VI (Article 91), Supplementary Provisions—Final (Eighth), and Annex 1

Last content review/update: March 21, 2024

New Info (Not Yet in Profile)

As of November 20, 2024, CREC’s online submission system is suspended. All research project documents should be submitted via email to official@crecthailand.org. See the announcement on CREC’s website.

Overview

In accordance with ClinImprtOrdr and G-CT-DIPApp, the sponsor or the contract research organization (CRO) is responsible for submitting a drug import license application for clinical research purposes to the Thai Food and Drug Administration (Thai FDA). Per ClinSampleProd and DrugProdReqs, the Thai FDA is also responsible for approving requests for permission to produce drug samples for the registration of drug formulas for human research studies.

As set forth in ClinImprtOrdr, ClinSampleProd, and ECRegProc, the Thai FDA’s approvals of a drug import license and of a request for permission to produce drug samples for human research studies are dependent upon obtaining proof of ethics committee (EC) approval from the Thai FDA to conduct the clinical trial. ClinImprtOrdr and ClinSampleProd further specify that for both types of approval requests, the application is either submitted to the Thai FDA after the research project and all the research sites have been approved by an EC, or in parallel, pending review by at least one (1) EC involved in the study. (Note: Per ClinImprtOrdr, the sponsor is also referred to as the applicant or importer.)

Regulatory Submission

OSSC Pre-Submission Permission

According to THA-77 and THA-75, prior to submitting a drug import license application (N.Y.M.1 form), an applicant must first request permission from the Thai FDA’s One Stop Service & Consultation Center (OSSC) (THA-35) to use the OSSC’s online consultation system (E-Consult) (THA-77). Per THA-65, requesting E-Consult permission is a two-part process that initially requires applicants who are Thai citizens to create a user account and register via Digital ID (THA-89) which enables Thai citizens to access all government agency electronic services using a single user account/password. The user account can then be used to submit applications and supporting documentation to the Thai FDA’s Medicines Regulation Division via the Skynet E-Submission System (THA-54).

Per THA-65 and THA-77, once registered in THA-89, Thai applicants (i.e., the general public, entrepreneurs, or researchers) are subsequently required to provide documentation to E-Consult (THA-77) to confirm that they, or representatives authorized to act on their behalf, are authorized to use the FDA’s Skynet E-Submission System (THA-54). Although non-citizens cannot register directly with THA-89, they can request permission to authorize a juristic person who receives power of attorney (i.e., agency representatives, registration agents, or researchers who submit applications on behalf of an agency). Documentation should be submitted to E-Consult (THA-77) either in person or via email (econsultcenter@fda.moph.go.th) specifying in the subject line: “Request to open the right to use the information system.”

Per THA-77, for Thai applicants, this documentation includes:

Form for Requesting Permission to Use the Health Product Consultation Information System (E-Consult) (THA-80)
Copy of identity card

Per THA-77, for juristic applicants with power of attorney, this documentation includes:

Form Requesting Power of Attorney Permission to Use the Health Product Consultation Information System (E-Consult) (THA-81)
Copy of juristic person certificate (if any)
Power of attorney form
Copy of identity card of grantor (the national identity card issued to Thai citizens)
Copy of identity card of attorney-in-fact (refers to a passport)

THA-66 indicates that when an applicant completes the process of submitting an in-person request within one (1) day at the service center, a service provider can then forward the request for review and may receive a response within one (1) day. For requests that take more than one (1) day to be reviewed, the service center will forward the application to the Product Division for consideration. See also THA-51 for additional information on services provided by the OSSC’s E-Consult Service.

Import and Export Division Pre-Submission Permission

Per THA-79, the Thai FDA’s Import and Export Inspection Division also requires applicants to request permission to access the Skynet E-Submission System (THA-54) prior to being permitted to submit a drug import waiver application for clinical trial purposes. Applicants requesting access may submit documentation via email to bie.thaifda@gmail.com to open temporary rights first. After reviewing the emailed documentation for correctness/completeness, the officer will reply to the email and request original copies of the documents. A request for permission can also be mailed to the OSSC (THA-35), 4th floor. Also, per THA-87, Thai applicants may register and submit authorization documentation via THA-54 once they have obtained access.

THA-79 states that for Thai applicants, the required authorization documentation includes:

Copy of the registration certificate of the company or partnership, or a copy of the commercial registration (which has been issued no more than six (6) months and has a grantor to sign)
Copy of grantor’s identity card (which has not expired on the date of document submission along with a signature to certify the copy)
Copy of the identity card of the attorney-in-fact (which has not expired on the date of document submission along with a signature to certify the copy)

THA-79 further notes that the applicant has the right to use the Skynet E-Submission System (THA-54) for import/export purposes for no more than one (1) year. The following forms are also provided on the Import and Export Inspection Division webpage (THA-85) to complete these requests: Form Requesting Access to the FDA E-Submission System for Permission to Import Drugs for Other Purposes (THA-83), Form Requesting Power of Attorney Access to the FDA E-Submission System for Permission to Import Drugs for Other Purposes (THA-82), and Application Form for Medicine Importation (THA-84). See also THA-85 for additional related forms that may be useful.

Submissions

N.Y.M.1

As delineated in ClinImprtOrdr, the Thai FDA accepts paper and electronic clinical trial application submission packages for requests to import or order drugs for clinical research. However, paper applications are only to be submitted at the discretion of an agency officer when it is determined that the application process cannot be completed electronically via the Skynet E-Submission System (THA-54) for Medicines Regulation Division review and approval (see Submission Content section for content details).

As per ClinImprtOrdr, for paper submissions, sponsors must submit two (2) original sets with real signatures of the completed N.Y.M.1 form (ClinImprtOrdr (Appendix 2) and THA-18 (Appendix 2)) with the required attachments to the Thai FDA. For paper submissions, the applicant must also submit an MS Word template file for importing the data electronically, so that the file can be connected to the information in the drug importation and clinical research sections in the information system. A copy of all the submitted documents should also be provided in PDF format. G-CT-DIPApp also states that two (2) sets of the application package must be submitted to the Thai FDA. Per ClinImprtOrdr, if the Thai FDA reviewer determines that submitted documents require correction or additional documentation needs to be submitted, the applicant must make corrections/clarifications based on the evaluation results within the specified time by submitting a correction/clarification request form (see ClinImprtOrdr (Appendix 12) and THA-18 (Appendix 12)).

Additionally, per ClinImprtOrdr, the non-local applicant must authorize a qualified person through a power of attorney to submit an application and respond to requests to provide clarification, amend, and/or receive documents related to the submission. The attorney-in-fact should be someone who has knowledge in pharmacy or a related medical field as well as an understanding of requests, permissions, etc. relating to the application submission and associated documentation. The scope and responsibilities of the attorney-in-fact must be specified in the authorization to include filing application submission clarifications and corrections. The authorization documentation should be submitted with the paper application. ClinImprtOrdr further notes that one (1) set of power of attorney submission documentation may only be used for one (1) application submission request.

ClinImprtOrdr also states that the application submission should include documentary evidence for quality control and drug production separated by drug. The identification of the manufacturer of each drug included in the submission must match the one specified in the Microsoft Excel files for the Logistics System (See ClinImprtOrdr (Appendix 7) and THA-18 (Appendix 7) for the manufacturer’s form).

As indicated in ClinImprtOrdr and G-CT-DIPApp, Thai and English are the preferred languages for use in preparing an application package for requests to import or order drugs for clinical research. The following requirements are specified (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

Research project name and summary of research project in Thai
Drug packaging documents for already registered drugs presented in Thai or English (Note: if drug formula documentation from abroad is in a foreign language other than English, then it should be translated into Thai or English and certified that the text matches the Thai/English language version)
Protocol synopsis in Thai
Detailed study protocol specification (completed version of study protocol) in Thai or English
Patient information sheet in Thai or translated to an appropriate language and certified the text matches the Thai version
Drug labels for every package size in Thai or English
EC approval document in Thai
Certificate of Free Sale in English and translated by a trusted certification authority and any other language in which it has been originally issued
Progress report in Thai

Additionally, as explained in THA-79, once the applicant has obtained permission from the Import and Export Inspection Division to access the Skynet E-Submission System (THA-54), a drug import waiver application (N.Y.M.1) may be submitted electronically. Per THA-87, following official review of the submitted documentation, a response will sent within one (1) business day. THA-87 and THA-79 indicate that once the request is approved, a License Per Invoice (LPI) number will be used in making a goods declaration with the Thai Customs Department. See THA-48, THA-86, and THA-88 for additional information and instructions on submitting an LPI to Customs). Refer to THA-57 and THA-87 for detailed instructions on submitting a drug importation waiver request via the Skynet E-Submission System (THA-54).

P.Y.8

As indicated in ClinSampleProd, the Thai FDA also accepts paper and electronic clinical trial application submission packages for requests for permission to produce sample drugs for human research studies. However, if the electronic system is not available, the application must be submitted in paper form, along with the appropriate supporting documentation (see Submission Content section for content details). In the case of filing via the Skynet E-Submission System (THA-54), information will be filled in the system in a P.Y.8. form, and the research project information will be created automatically. If the Thai FDA reviewer determines that submitted documents require correction or additional documentation needs to be submitted, the applicant must make corrections/clarifications based on the evaluation results within the specified time by submitting a correction/clarification request form (see ClinSampleProd (Appendix 8) and THA-76 (Appendix 8)). The paper documentation should be submitted to the New Drugs and Drug Research Promotion Group within the Medicines Regulation Division or submitted electronically via THA-54. When submitting a paper application, the applicant must also submit a template file for importing the data via THA-54 to serve as a starting point for operators in the electronic process and for use in overseeing the trial. A copy of all the submitted documents should also be provided in PDF format.

Additionally, per ClinSampleProd, the non-local applicant must authorize a qualified person through a power of attorney to submit an application and respond to requests to provide clarification, amend, and/or receive documents related to the submission. The attorney-in-fact should be someone who has knowledge in pharmacy or a related medical field as well as an understanding of requests, permissions, etc. relating to the application submission and associated documentation. The scope and responsibilities of the attorney-in-fact must be specified in the authorization to include filing application submission clarifications and corrections. The authorization documentation should be submitted with the paper application, or via the Skynet E-Submission System (THA-54), if the application is being submitted electronically. ClinSampleProd further notes that one (1) set of power of attorney submission documentation may only be used for one (1) application submission request.

As indicated in ClinSampleProd, Thai and English are the preferred languages for use in preparing an application package to request permission to produce investigational drugs for clinical research. The following requirements are specified:

Research project name in Thai and English
Summary of research project in Thai
Drug labels for every package size in Thai or English
Patient Information Sheet in Thai
EC approval document in Thai
Complete research project details in Thai or English

OSSC Contact Information for Application Submissions

Per THA-74, THA-65, and THA-77, the following is contact information for submitting an application to the OSSC (THA-35) in person or via email, and for requesting permission to access the Skynet E-Submission System (THA-54):

One Stop Service Center (OSSC)
Building 6, 5^th Floor
Food and Drug Administration Building
Ministry of Public Health
88/24 Tiwanon Road
Talat Khwan Subdistrict
Mueang District, Nonthaburi Province 11000

Email (E-Consult): econsultcenter@fda.moph.go.th
Phone: 02 590 7614 (Consultation E-service for general inquiries, reporting usage problems, and issues related to requesting permissions)

See also THA-52 for the Medicines Regulation Division staff list.

Ethics Review Submission

Per G-ResEthics, each institutional EC should establish its own requirements for protocol submission along with the required documents including the application, number of research protocol copies to be submitted, the patient information sheet, the informed consent form, and the case report form. Each EC should also communicate these requirements to personnel or staff within the institution.

According to THA-4, if a trial site is not affiliated with a Thai FDA-recognized EC, the investigator(s) usually needs to apply to two (2) ECs for approval—the unaffiliated local EC and a central EC approved by the Thai FDA. THA-1 further explains that both the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH) and the Central Research Ethics Committee (CREC) are categorized as central ECs because they can accept all clinical research studies for review, regardless of the trial sites involved.

Ethical Review Committee for Research in Human Subjects, Ministry of Public Health

According to THA-13, the ECMOPH requires one (1) original and 20 copies of the protocol submitted in Thai, and one (1) copy submitted in English for review purposes.

Per THA-41, investigators can electronically submit applications to the ECMOPH to obtain approval for new research projects or to request other services via the ECMOPH e-submission login page (THA-40).

Central Research Ethics Committee

THA-36 and THA-29 indicate that investigators applying for a new research project should submit an application to the CREC for review via its Online Submission System (THA-43).

THA-29 further explains that in some cases, hard copies may be requested by the CREC officer, with the number of additional hard copies requested subject to the reviewer’s requirements. Per THA-29, one (1) set of hard copy documents, consisting of a project folder and a CD with project information should be submitted. Documents should be placed in a folder indicating the correct number of files in order to avoid processing delays.

THA-29 also states that if a local EC requires a hard copy for the local assessment, the CREC will prepare an introduction letter and local issue assessment form. These documents will be sent to every local EC by email; the researcher/coordinator will be copied on this email. The researcher/coordinator will attach the local CREC introductory letter and assessment form to the hard copy submission package for the local EC.

See also THA-34 for detailed application package documentation submission requirements, and THA-37 for a comprehensive list of all the CREC Standard Operating Procedures (SOPs).

Per THA-34 and THA-38, in the case where the research project is in English, a brief research outline should be provided in Thai as well. In addition, an explanation about the research participants and letter of intent to consent should be provided, if the master version of the informed consent documents are written in English.

Which EC?

Saving time...and cost!

Guidelines for the preparation of a research proposal submitted to the Ethical Review Committee for Research on Human Subjects, Ministry of Public Health (p. 67)

Chapters 1-2

Requirements before using the E-consult system, Applying for service, Requesting Permissions, and Form

1 and 3

4-5

Appendices 1-4 and 7-9

Appendices 1-13, 15, and 17

Online Submission – For Researchers/Research Coordinators

1. Introduce the Ethics Request System (E-Submission)

6.1

3, 11-13, and 15

1-2 and Appendices 1-4 and 7-9

Preface; Summary of Changes in this Edition; 1-3; and Appendices 1-13, 15, and 17

5 and Form EC-1

Appendix 12

Submission Content

Last content review/update: April 24, 2024

Regulatory Authority Requirements

As specified in Decree021-2017, Res655-2019 (which amends Decree021-2017), the INS-CTManual, Res252-2022 (which amends the INS-CTManual), PER-71, and PER-83, a clinical trial application submission must include the following documents (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Application for clinical trial authorization and proof of payment (PER-24) (per Annex B in Res655-2019)
Approval(s) issued by legal representative of institution(s) where research will be conducted (per Annex 1 in INS-CTManual and Annex 2 in Res252-2022)
Copy of the approved research protocol and informed consent form (ICF) stamped and signed by the ethics committee (EC) in its entirety (per Annex 3 in INS-CTManual and Annex 3 in Res252-2022)
Research protocol in Spanish, and in the original language if different from Spanish, submitted in electronic form as an editable PDF (per Annex B in Res655-2019)
ICF in electronic form as an editable PDF (per Annex B in Res655-2019)
Updated Investigator’s Brochure (IB) in Spanish, and in the original language if different from Spanish, submitted in electronic form as an editable PDF (per Annex B in Res655-2019)
Affidavit stating no conflict of financial interest signed by the sponsor or the contract research organization (CRO) and the principal investigator (PI) (PER-34)
Affidavit signed by the PI and sponsor on preparation of research institution for trial (PER-35)
In the case of foreign sponsor: copy of proof of delegation of functions to the sponsor representative, duly authenticated by Peru’s Ministry of Foreign Affairs
Affidavit on compensation for participants signed by the sponsor or the CRO and PI (covers budget and expenses for any trial-related injuries) (PER-51)
Copy of current insurance policy purchased by the sponsor
List of clinical trial supplies (PER-42)
Information related to the investigational product (IP) quality (electronic form) (per Annex B in Res655-2019)
Updated curriculum vitaes (CVs) of all research team members with attached copies (PER-50) (per Annex B in Res655-2019)
Copy of documents demonstrating training in Good Clinical Practices and Research Ethics in human beings for the entire research team within the past three (3) years (PER-50) (per Annex B in Res655-2019)
Detailed national budget total for trial form (PER-25)
Copy of current record of authorized research institution(s) for clinical trials
Payment receipt for research site registration; in the case of multicenter trials, proof of payment for processing fee (per Annex B in Res655-2019)

Refer to Decree021-2017, Res655-2019, the INS-CTManual, Res252-2022, and PER-71 for detailed submission information; PER-24 for the recently amended clinical trial application form per Res0423-2019; and PER-10 for detailed instructions on completing the form.

See also the Submission Process section for additional submission requirements, and PER-6 for a flowchart delineating the clinical trial authorization process.

Trial Extensions

Decree021-2017, Res655-2019, PER-72, PER-27, and PER-93 indicate that the sponsor or the CRO must submit the following documents for clinical trial application extensions: (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Application for extension of time to conduct the clinical trial, explaining the reasons for such request and stating the number and date of the proof of payment of processing fees (using FOR-OGITT-037 (PER-27)) per PER-72
Copy of the document approving the time extension granted by the legal representative of the research institution(s) where the trial will be conducted
Copy of the document containing the time extension approval by an National Institute of Health (Instituto Nacional de Salud (INS))-accredited EC

Report justifying the reasons for submitting the request
Current insurance policy

Ethics Committee Requirements

Specific institutional EC requirements are not provided in Peru’s regulatory sources. However, according to PER-77, ECs generally require PIs to submit the following documentation for ethics approval:

Letter from the PI to the EC Chairman
Basic Format Application
Research protocol
ICF
PI and co-investigator(s) CV(s)
Declaration of the PI and research site director/research institution head
Declaration of financial details and potential conflicts of interest of the PI
Sponsor’s insurance policy
PI’s training in good clinical practices and human research ethics

Clinical Protocol

As delineated in Decree021-2017, the clinical protocol should contain the following elements:

General information
Protocol summary
Background and justification (including IP description) (See Investigational Products topic for detailed coverage of this subject)
Objectives, valuation criteria, or specific results and hypotheses
Test design
Participant selection/withdrawal
Participant treatment
Study evaluation and procedures
Adverse events (See Safety Reporting section for additional information)
Statistical considerations
Data collection and monitoring
Data management and record maintenance
Ethical aspects
Publications results
Bibliography
Appendices

For complete protocol requirements, refer to Annex 1 of Decree021-2017.

Clinical Trial Authorization and Extension for a Clinical Trial (English website); Clinical Trial Time Extension (Spanish website)

Chapter IX (Forms), Chapter X (Annex 1, Annex 3, and Annex 4 (Flowchart No. 04))

Annexes A and B

Preamble, Article 1, and Annex 3

Requirements for Initiating the Procedure and Annexes 1-9

Title V (Article 67) and Annexes 1-2 and 4-5

Last content review/update: March 21, 2024

Regulatory Authority Requirements

N.Y.M.1

As per ClinImprtOrdr and G-CT-DIPApp, sponsors must submit the following documents to the Thai Food and Drug Administration (Thai FDA) to request a drug import waiver request (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

Cover letter
Application for Permission to Import or Order Drugs for Research Purposes in the Kingdom (N.Y.M.1 form) (see ClinImprtOrdr (Appendix 2) and THA-18 (Appendix 2))
Checklists and Attached Documents for N.Y.M.1 form (see appendices in ClinImprtOrdr and THA-18)
Drug labels for every package size in Thai or English
Package inserts (for registered drugs)
Prescriptions (for registered drugs)
Investigator’s Brochure (IB) (for unregistered drugs)
Informed Consent Form in Thai
Patient Information Sheet in Thai
Research project summary in Thai
Completed version of study protocol in Thai or English
Chemistry, manufacturing, and control (CMC) information
Ethics Committee (EC) approval from a Thai FDA-recognized institutionally-based EC and/or an independent EC. If waiting for approval from the relevant EC, instead submit the latest protocol version under consideration.
Estimates of the amount of study drug, comparators, or other goods to be imported
Certificate of Analysis
Certificate of Free Sale in English and other language used
Drug registration authorization document
Summary of product characteristics
Literature review
Description (name and content) and pictures of lab/materials to be imported
Power of attorney
Investigational medicinal product (IMP) information

Per ClinImprtOrdr, when an applicant authorizes a qualified person through a power of attorney to submit an application package, the following documents must also be included with the submission:

Copy of identity card of the grantor and the attorney-in-fact with signatures to certify that they are true copies
Stamp duty in the amount of 30 Baht per one (1) power of attorney designation

As delineated in G-CT-DIPApp, applicants are also required to submit the following documents to the Thai FDA regarding EC approval:

Protocol title
List of principal investigator(s) (PIs)
Proposed study site
List of documents reviewed and approved by the EC, including the document version
Period of approval and/or date of expired approval

As noted in ClinImprtOrdr, the Ministry of Public Health (MOPH) may also establish an academic committee or subcommittee for certain drugs requiring special supervision (e.g., the Academic Subcommittee on AIDS Vaccine Trials to review AIDS vaccines, etc.). Therefore, when submitting an application to request permission to import or order a specialized drug for clinical research requiring this type of oversight, an additional approval letter from the relevant committee is also required. Additional information on obtaining the approval for the committee is not available.

P.Y.8

Per ClinSampleProd, applicants must submit the following documents to the Thai FDA to request permission to produce drug samples for the registration of drug formulas for human research studies:

Application for Permission to Produce Drug Samples for Drug Formula Registration (P.Y.8. Form) (see ClinSampleProd (Appendix 1) and THA-76 (Appendix 1))
Research project summary in Thai
Certification of compliance with the terms and conditions related to the production of drug samples for use in human research studies
Certificate of Compliance for Principal Investigators
Evidence of insurance or compensation
Power of attorney (for paper submissions)
A copy of the license to produce modern drugs (for paper submissions)
Drug labels for every package size in Thai or English
Copy of Good Manufacturing Practice (GMP) Certificate
Drug leaflet (for bioequivalence study drugs)
IB (for research drugs)
Patient Information Sheet in Thai
EC approval from a Thai FDA-recognized institutionally-based EC and/or an independent EC, except in the case of waiting for approval from the relevant EC
Drug quality control and pharmaceutical production documentation
Documents approved by relevant technical committees (if any)
Complete research proposal in Thai or English
Document self-verification form (see ClinSampleProd (Appendix 7) and THA-76 (Appendix 7))

Per ClinSampleProd, when an applicant authorizes a qualified person through a power of attorney to submit an application package, the following documents must also be included with the submission:

Copy of identity card of the grantor and the attorney-in-fact with signatures to certify that they are true copies
Stamp duty in the amount of 30 Baht per one (1) power of attorney designation

As noted in ClinSampleProd, the MOPH may also establish an academic committee or subcommittee for certain drugs requiring special supervision (e.g., the Academic Subcommittee on AIDS Vaccine Trials to review AIDS vaccines, etc.). Therefore, when submitting an application to request permission to import or order a specialized drug for clinical research requiring this type of oversight, an additional approval letter from the relevant committee is also required. Additional information on obtaining the approval for the committee is not available.

Ethics Committee Requirements

Per G-ResEthics, each institutional EC should establish its own requirements for protocol submission along with the required documents including the application, number of research protocol copies to be submitted, the patient information sheet, the informed consent form, and the case report form. Each EC should also communicate to personnel or staff within the institution.

Ethical Review Committee for Research in Human Subjects, Ministry of Public Health

Per THA-13, the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH) requires investigators (applicants) to submit the following documentation for ethics approval:

One (1) original set and 20 copies of the protocol in Thai and one (1) copy in English for review
Ethical considerations
Combined information sheet and informed consent certificate for research participants
Budget details and funding source
Curriculum Vitae (CV) for each research team member
Letter of approval from implementing institution
Results of ethical review by EC of implementing institution, if available
Data collection/questionnaire tools
Letter signed by PI’s supervisor
For an international project, Thai and foreign PIs required for each side
Material transfer agreement for transfer of blood or biomedical samples
References

Refer to THA-13 for detailed ECMOPH submission requirements respectively.

Central Research Ethics Committee

According to THA-34 and THA-38, investigators applying for an initial research project review by the Central Research Ethics Committee (CREC) should submit the following:

Books/memorandum for research presentation signed by investigator (Word and PDF files required)
Ethics Consideration Proposal Form for Biomedical Research Projects (CREC form AP 04-S04) signed by investigator (Word and PDF files required)
Complete research proposal
Brief research proposal in Thai
Documents clarifying information about research participants and letter of intent to consent (in the case of a master informed consent form (ICF) version, single document in English is used for all institutions; alternatively, each institution may also use their own documents) (See also THA-46 for ICF template and checklist links)
Case report form
IB (including Investigator’s Guide; a certificate that the drug has been approved by the Thai FDA; invoice in the case of a drug that has been registered with the Thai FDA; and a drug leaflet)
Other documents (including questionnaire or interview form; notebook; documents for invitation to participate in the research, such as brochures, posters, public relations scripts; other documents applicable to volunteers/research participants; documents requiring issuance of a certificate)
Research injury compensation insurance documents
Material transfer agreement (MTA) (must be uploaded according to each institution’s form)
(Draft) Research project budget
Letter of approval from the junior supervisor (separate documents by institution) (including a list of researchers at all data collection institutes in Thailand)
Investigator CVs and evidence of good clinical practice (GCP) training or research ethics training
Conflict of Interest Form completed by PIs/co-investigators (CREC form AP 06-S04) (separate documents by institution)
Research Outline Completeness Check Form (CREC form AO 01-S04)
PI for clinical trial phase I/II research projects (CREC form AP02-S04)
Proof of fee payment

Refer to THA-34 and THA-38 for detailed CREC submission requirements.

Clinical Protocol

As delineated in ClinImprtOrdr, ClinSampleProd, G-ResEthics, and G-CT-DIPApp, the clinical protocol should include the following elements (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Protocol summary/synopsis
General information (e.g., sponsor and investigator(s) name(s) and address(es))
Background information (e.g., investigational product name and description)
Trial objectives and purpose
Trial design
Number of trial participants
Participant selection/withdrawal criteria
Participant treatment
Safety and efficacy assessments
Quality control/quality assurance
Adverse event reporting requirements (See the Safety Reporting section for additional information)
Statistics and methods to track trial data
Sponsor specifications for direct access to source data/documents
Ethical considerations
Data management and recordkeeping
Financing and insurance details
Publication policy
Supplements
Information about each research facility in Thailand
Number of institutions participating in the research in Thailand
Other countries where the research project is being conducted
IMPs to be used

For complete protocol requirements, refer to ClinImprtOrdr and Annex 6 of G-ResEthics, which is directly based upon the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (THA-28) and the ICH guideline Structure and Content of Clinical Study Reports (E3) (THA-27). Per an in-country subject matter expert, Thailand is implementing THA-28. Both of these ICH guidelines are also referenced in G-ResEthics.

G-CT-DIPApp also provides protocol synopsis requirements for submission to the Thai FDA. Please refer to G-CT-DIPApp for detailed information.

In the instance of a multicenter clinical trial, G-ResEthics indicates that protocols submitted to each institutional EC should contain the same content and should specify the quality control techniques to ensure that the research practices are the same in each institution.

Also, see THA-13 for ECMOPH and THA-29 for CREC protocol submission requirements. (See also THA-18 and THA-76 for the forms included in the appendices in ClinSampleProd and ClinImprtOrdr.)

Guidelines for the preparation of a research proposal submitted to the Ethical Review Committee for Research on Human Subjects, Ministry of Public Health (p.67); Ethical Criteria

Appendices 1-2 and 7

Appendix 2-11 and 13

6

Annex 6

3, 12-13, and 15

Preface, 1, 4, and Appendices 1-2, and 7

Summary of Changes in this Edition, 1, 3, and Appendices 1-11, and 13

Timeline of Review

Last content review/update: April 24, 2024

Overview

Based on Decree021-2017, Res655-2019 (which amends Decree021-2017), the INS-CTManual, and Res252-2022 (which amends the INS-CTManual), the National Institute of Health (Instituto Nacional de Salud (INS))’s review and approval of an application to conduct a clinical trial is dependent upon obtaining ethics committee (EC) approval from an INS-accredited EC. Therefore, the INS and EC reviews may not be conducted in parallel.

Regulatory Authority Approval

As per Law27444 and Decree004-2019 (which amends Law27444), the INS is required to complete its review and approval of a clinical trial application in a maximum of 30 working days. Per Decree021-2017, this timeline includes the 30-day requirement for the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)) to issue a binding technical opinion on the safety and quality of the investigational product (IP). (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)) (PER-109)).

As explained in the INS-CTManual and Res252-2022, the person in charge of the Documentary Processing Area (Área de Trámite Documentario (ATO)) receives the application file and reviews the file with a health professional assigned from the DIIS’s Clinical Trials Subdirectorate (Subdirección de Ensayos Clínicos) (formerly known as the Executive Office of Investigation (Oficina Ejecutiva de Investigación (OEI))) to ensure completeness. The applicant has a maximum of two (2) business days to make any corrections that have been identified. If the corrections have not been made in the required timeline, the file is returned to the applicant, who is reimbursed for any processing fees. If the file is deemed complete and any required corrections have been addressed, the file is assigned a registration number in SIGNANET, the INS’s integrated administrative management system. Res252-2022 further explains that the authorization request procedure is formally initiated when the sponsor is provided with the file registration number. At this stage, an identification number is also assigned to the clinical trial in the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) (PER-89) (also referred to as REPECv2).

Per Res252-2022, the file is then forwarded to the Clinical Trial Processing Area (Área de evaluación de Ensayos Clínicos (AEC)). Upon receipt of the application file, the AEC reviewer receives the file and sends the list of clinical trial supplies (PER-42) along with the required documentation in Annex 5 of Decree021-2017 to the Research Product Safety Surveillance Area (Área de Vigilancia de la Seguridad del Producto en Investigación (AVISPI)). AVISPI, in turn, sends this documentation to the ANM to request a binding technical opinion on the IP safety and quality. Concurrent with the request for the ANM’s review, the AEC reviewer evaluates the file, including the ANM binding technical opinion once received, and prepares a draft evaluation report which is reviewed by the Functional Clinical Trials Team (Equipo Funcional de Ensayos Clínicos (EFEC)) coordinator. If agreed to, the EFEC coordinator forwards the file to the Clinical Trials Subdirectorate’s Legal Advice Functional Team (Equipo Funcional de Asesoría Jurídica (EFAJ)) who prepares a report for the Clinical Trials Subdirectorate Executive Director’s review.

The Clinical Trials Subdirectorate Executive Director reviews the evaluation documents and legal report generated by the EFEC and the EFAJ. If the evaluation is agreed to, then the Executive Director signs the report, approves the project, and sends it to the INS’s DIIS, who also reviews and approves the file and signs off on the project. Otherwise, the file is returned to the EFEC to be handled as a non-compliant project. The process is finalized when the sponsor or the CRO is notified of the approval. The DIIS secretary registers the decision in SIGANET and all documentation is registered in PER-89. Per Decree021-2017, the sponsor has the right to appeal when the INS does not grant authorization.

Per Decree021-2017, any modifications of the conditions under which a clinical trial was authorized, and amendments to the research protocol and/or informed consent, require prior authorization from the INS’s DIIS.

Decree028-2023 (which amends Decree021-2017) further specifies that a minor change(s) to the protocol and/or informed consent form (ICF), only requires the approval of the INS registered and accredited EC that originally approved the current version, and the sponsor must communicate the change(s) in writing to the INS’s Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) (formerly known as the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT))) within 10 business days prior to its implementation. Per Decree028-2023 and Res184-2023 (which amends Decree021-2017), a minor change does not generate a new version of the protocol or ICF; however, if a subsequent amendment is made to the protocol, it must also contain the minor change(s) made. (See Scope of Assessment and Scope of Review sections for additional information on submitting minor changes to the INS’s DIIS.)

Per Decree021-2017, Res655-2019, PER-72, and PER-93, the sponsor or the CRO should also request a trial extension within 30 calendar days prior to the trial’s expiration. The authorized trial extension will be valid for a maximum of 12 months from the date of issue.

Ethics Committee Approval

The EC review and approval process timeline varies by institution.

Chapter VII (7.1-7.2) and Annexes 1, 3, and 4 (Flowcharts No. 01 and 04)

Article 35

Annex 1

Annexes A and B

Article 2 (Article 85-A)

Preamble, Requirements for Initiating the Procedure (3, 10, and 13), 2.1-2.3, 3.1-3.4, 4.1-4.4, 5.1-5.7, 6.1-6.2, 7.1-7.6, and Annexes 1-3 and 9

Article 39

Title I (Articles 6 and 8), Title IV (Articles 40, 59, and 63), Title V (Articles 67, 69-71, 75, and 80), Supplementary Provisions—Final (Eighth), and Annex 5

Last content review/update: March 21, 2024

Overview

ClinImprtOrdr specifies that a drug import license application for clinical research purposes is submitted to the Thai Food and Drug Administration (Thai FDA) after the research project and all the research sites have been approved by the ethics committee (EC), or in parallel, pending review by at least one (1) EC involved in the study. Per ClinSampleProd and DrugProdReqs, the application to produce drug samples for the registration of drug formulas for human research studies must also be submitted to the Thai FDA either after the research project and all the research sites have been approved by an EC, or in parallel, pending review by at least one (1) EC involved in the study.

Regulatory Authority Approval

As specified in THA-78, the Thai FDA has 60 working days to evaluate an application to import or order drugs in the country for clinical research (N.Y.M.1); 60 working days to evaluate an application to produce drug samples to request modern drug registration for human research studies (P.Y.8); 20 working days to review an application to amend a N.Y.M.1 or P.Y.8 submission; one (1) working day to review an application for a certificate of pharmaceutical product (Certificate of Pharmaceutical Product/Certificate of Free Sale); and 30 working days to evaluate the accuracy and translation of a Good Manufacturing Practice (GMP) assessment report from a Thai version to an English version.

Per G-CT-DIPApp, upon receipt of an application package, the Thai FDA’s One Stop Service & Consultation Center (OSSC) (THA-35) sends the application package to an officer in the Thai FDA’s International Affairs and Investigational Drug Section. The officer then screens the package for completeness and informs the eligible sponsor of the results within five (5) working days from the date the application was received. If deemed complete, the officer sends the package to the assigned technical reviewer to proceed. If the officer finds the package to be incomplete, a “Screening Result Notification form” will be sent to the applicant or the applicant’s attorney for correction. If the applicant or the applicant’s attorney fails to fully correct the package within five (5) working days, then the Thai FDA will send a rejection letter and return all the documents to the applicant. However, the applicant may later correct or amend the application package and resubmit it to the OSSC. Once the correction is completed, the officer will send the application package to the assigned reviewer to proceed.

Per G-CT-DIPApp, the reviewer then receives the application package and performs a technical assessment. If the reviewer determines the package is technically correct, then it will be forwarded to the Thai FDA’s Secretary-General for approval. If the reviewer finds the application package technically incorrect, then it will be forwarded to the Thai FDA’s Secretary-General for rejection. If the reviewer finds the technical information to be incomplete, then the applicant or the applicant’s attorney will be asked to clarify and/or submit additional documents/information. If the documentation or amended information is not submitted within five (5) working days, the Thai FDA will issue a rejection letter and return the package to the applicant. However, the applicant may resubmit a corrected package to THA-35 (timeline not specified in G-CT-DIPApp). If the applicant can completely correct the application package, the officer will forward the package to the assigned reviewer for re-assessment.

In addition, ClinImprtOrdr and ClinSampleProd further specify that once the Thai FDA receives the EC approval documentation, the agency will complete its review within 15 days. See also THA-18 (Appendix 13) and THA-76 (Appendix 9) for the form to submit results of EC review to the Thai FDA. Refer to the Submission Process and Submission Content sections for detailed submission requirements.

Ethics Committee Approval

The review and approval process by a Thai FDA recognized EC will vary by institution. However, according to THA-13, which provides the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH) requirements, and THA-5, which provides more general EC requirements, the EC review and approval process can take between two (2) and three (3) months.

Per G-ResEthics, each EC should establish its own requirements for protocol submission and timeline of review.

Clinical Trials

Instruction for the Submission of a Study/Research Proposal to be Reviewed by the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (p. 63)

Appendices 1-3, 7, and 9

Appendices 2-4, 11, and 13

Items 2, 11, 33, 34, and 49

Annex 6

2-3 and 15

1-3, and Appendices 1-3, 7, and 9

1, 3, and Appendices 1-4, 11, and 13

Appendix 12

Initiation, Agreements & Registration

Last content review/update: April 24, 2024

Overview

In accordance with Decree021-2017, Res655-2019 (which amends Decree021-2017), the INS-CTManual, and Res252-2022 (which amends the INS-CTManual), a clinical trial can only commence after the sponsor or the contract research organization (CRO) receives authorization from Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) and approval from an INS-accredited institutional ethics committee (EC) (El Comité Institucional de Ética en Investigación (CIEI)). No waiting period is required following the applicant’s receipt of these approvals.

According to Decree021-2017, Decree016-2011, the INS-CTManual, and Res252-2022, the sponsor or the CRO must also obtain approval from the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)) to manufacture or import investigational products (IPs) and to obtain an import license for the shipment of IPs to be used in the trial. (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)) (PER-109)). (See the Manufacturing & Import section for additional information).

Additionally, per Decree021-2017 and Res252-2022, the sponsor must ensure authorization by the research institution where the clinical trial will be carried out. Decree021-2017 further states that the sponsor must inform the INS’s Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) (formerly known as the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT))) when the first research participant is enrolled in Peru as well as the enrollment termination date in the country.

The INS-CTManual further specifies that the trials should be conducted in compliance with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (PER-53).

Res686-2020, in turn, states that clinical studies of vaccines in humans must be conducted in accordance with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (PER-53) and current national clinical trial regulations (Decree021-2017). Refer to Res686-2020 for detailed information and requirements associated with clinical vaccine studies.

Clinical Trial Agreement

According to Decree021-2017, the INS-CTManual, Res252-2022, and PER-71, the sponsor and principal investigator (PI) must sign an affidavit of compliance with the minimum requirements of the research site where the clinical trial will be executed (see PER-35). Further, per Res252-2022 and PER-71, both the sponsor and the PI must sign an affidavit establishing that there is no conflict of financial interest in executing the trial (PER-34).

In addition, per Decree021-2017, the INS’s DIIS refers to the requirements laid down in PER-53 for topics not addressed in Decree021-2017. Accordingly, PER-53 states that prior to entering into an agreement with the investigator(s) and the institution(s) to conduct a study, the sponsor or the CRO should provide the investigator(s) with the protocol and an investigator’s brochure (IB), and ensure that they agree to comply with good clinical practices and ethical standards. The sponsor and the investigator/institution should sign the protocol, or an alternative document, to confirm this agreement.

Clinical Trial Registration

As per Decree021-2017, the INS-CTManual, Res252-2022, and PER-71, the sponsor or the CRO must register the clinical trial application electronically using the INS’s Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) (PER-89) (also referred to as REPECv2), at which time, a registration code is assigned to the application.

As specified in PER-89, the REPEC platform should be used to register all requests for procedures related to newly submitted clinical trials, to track the status of the authorization process, to identify critical events that require immediate attention via an alert system (e.g., expiring or expired authorizations and necessary notifications per Decree021-2017, and to obtain updated information on clinical trials being conducted in Peru). However, per PER-88, any requests for procedures related to already active clinical trials must still be submitted using the older REPEC platform via PER-91. See PER-81 for instructional videos on registering with the new REPEC platform. Refer to the Oversight of Ethics Committees section for instructions on EC registration/accreditation and the Submission Process section for instructions on sponsor/CRO registration.

4.5 and 5.6.2-5.6.3

Chapter VII (7.1-7.3), and Annexes 1, 3, and 4 (Flowcharts No. 01, 02, and 04)

Annex B

4 and 5.2

Requirements for Initiating the Procedure (2-3, 5-6, 10, and 13), 1.1-1.4, 4.1-4.4, and Annexes 3, 5, and 9

Title II (Chapters I and V)

Title I (Articles 6-8), Title IV (Articles 39-40, 45, 54, 59, and 63), Title V (Articles 67 and 70-71), Title VI (Article 94), Supplementary Provisions—Final (First and Eighth), and Annexes 1-5

Last content review/update: March 21, 2024

Overview

In accordance with ClinSampleProd, ClinImprtOrdr, and ECRegProc, a clinical trial can only commence after a sponsor receives approval of a drug import application for clinical research purposes or of a request to produce drug samples for human research studies from the Thai Food and Drug Administration (Thai FDA), as well as approval to conduct the clinical trial from a Thai FDA recognized ethics committee (EC). No waiting period is required following the sponsor’s receipt of these approvals. (See also THA-18 and THA-76 for the forms included in the appendices in ClinImprtOrdr and ClinSampleProd.)

Additionally, the clinical trial should be conducted in compliance with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28). Per an in-country subject matter expert, Thailand is now implementing THA-28.

Clinical Trial Agreement

G-ResEthics and THA-28 require the sponsor to sign a letter of agreement with the participating institution(s) before the trial begins. THA-28 also notes that any agreements between the sponsor and the investigator(s)/institution(s) and any other parties involved with the trial should be in writing either as part of the protocol or in a separate agreement.

Per THA-14, researchers should also abide by research obligations and agreements specified by and entered into with fellow researchers, funding agencies, and their affiliates.

Clinical Trial Registration

The ClinImprtOrdr application document checklist (Appendix 3) includes clinical trial registry information as one (1) of the items to be included in the application submission package, specifying that sponsors may register with either the Thai Clinical Trials Registry (TCTR) (THA-31) or a foreign registry. Sponsors may register in more than one (1) location.

2

Appendices 1-3, 7, and 9

Appendices 2-4, 11, and 13

1.25, 2.8, 4.1, 5.1, and 5.5

Annex 5 (6)

Preface, 1-3, and Appendices 1-4, 7, and 9

Preface, 1-3, and Appendices 1-4, 11, and 13

4-5 and 9-10

Safety Reporting

Last content review/update: April 24, 2024

Safety Reporting Definitions

According to Decree021-2017, Decree021-2017-Correct, the G-SafeRpt, and the G-CTSafety, the following definitions provide a basis for a common understanding of Peru’s safety reporting requirements (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Adverse Event (or Adverse Experience) (AE) – Any event or situation harmful to the health of the research participant to whom an investigational product (IP) has been administered, which does not necessarily have a causal relationship with its administration
Adverse Reaction (AR) – Any AE in which there is a clearly defined causal relationship with an IP or there is at least a reasonable possibility of causation, which occurs regardless of any dose administered to that participant
Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR) – Any AE/AR that results in death, is life threatening, requires or extends hospitalization, results in persistent or significant disability/incapacity, or causes a congenital anomaly/birth defect
Unexpected Adverse Reaction – An AR where the nature or severity is inconsistent with the applicable IP information, i.e., it is not described in the investigator’s brochure (IB) and/or the technical data sheet
Suspected Unexpected and Serious Adverse Reaction (SUSAR) – Any serious AE/AR in which there is at least a reasonable possibility of a causal relationship with the IP and the nature and severity of the event/reaction is not described in the IB and/or technical data sheet

Safety Reporting Requirements

Investigator Responsibilities

According to Decree021-2017, the INS-CTManual, and the G-SafeRpt, the principal investigator (PI) and the sponsor or the contract research organization (CRO) are responsible for monitoring the safety of the IP. As specified in Decree021-2017 and the G-SafeRpt, the PI is also responsible for notifying the sponsor or the CRO or the ethics committee (EC) of any SAEs/SARs and SUSARs within a period not exceeding one (1) calendar day from the date the event occurs, or, the PI becomes aware of the incident.

Decree021-2017 notes that the PI must also follow up with a detailed written report. Per the G-SafeRpt, the PI must record the SAEs/SARs and notify the sponsor according to the procedure described in the study protocol.

Furthermore, per Decree021-2017, the PI must inform the sponsor or the CRO and the EC of the following:

Any SAE/SAR that has occurred to a participant following the trial’s completion
Any non-serious AEs/ARs identified as determinants of safety assessments in the protocol within the periods specified

In addition, the G-SafeRpt states that if the PI becomes aware of SAEs/SARs occurring after the end of the trial, they should notify the sponsor or the CRO and the EC.

Lastly, per Decree021-2017, the PI must provide the sponsor or the CRO, the EC, and the Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) (formerly known as the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT))) within Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) with any additional safety information requested.

Res233-2020, which regulates human subjects research other than clinical trials of drugs or devices, indicates that investigators should immediately report to the EC and the corresponding authorities any AE or unanticipated risk to research participants related to the research. Furthermore, in cases where protocol or informed consent process changes are necessary to prevent harm to the participants, the investigators must submit report deviations within 24 hours.

Sponsor Responsibilities

According to Decree021-2017, the INS-CTManual, the G-SafeRpt, and PER-72, the sponsor or the CRO should report IP-related AEs/ARs, SAEs/SARs, and SUSARs and provide these reports to the INS’s DIIS. Decree021-2017 also notes that the sponsor or the CRO should also maintain detailed records of all AEs/ARs communicated by the PIs.

Per Decree021-2017, Decree021-2017-Correct, the INS-CTManual, PER-72, and PER-38, the sponsor or the CRO and the PI are required to submit all expected and unexpected SAEs/SARs (related or not per PER-72) and SUSAR reports electronically through the Serious Adverse Events Virtual Reporting System (Sistema de Reporte de Eventos Adversos Serios (REAS-NET)) (PER-69) to the DIIS within seven (7) calendar days from the occurrence of the incident, or as soon as the sponsor is aware of the incident. The G-SafeRpt specifies that the sponsor or the CRO is responsible for evaluating, categorizing, and reporting all SAEs/SARs and SUSARs that occur within the country through REAS-NET (PER-69). The notification should be completed using the online form, FOR-OGITT-046 (PER-38).

Per the INS-CTManual, the electronic form (PER-38) submitted via REAS-NET (PER-69) should be printed and signed by the sponsor or the CRO. The INS-CTManual and the G-SafeRpt state that the submitted information above must be updated with any additional relevant information in a follow-up tracking report within eight (8) calendar days. The G-SafeRpt also notes that if the causality assessment of the SAE conducted by the investigator differs from the causality assessment made by the sponsor, the investigator’s assessment cannot be modified. The INS-CTManual further states that both the follow-up report and the final report completed in REAS-NET (PER-69) should be submitted electronically and in print formats to the DIIS.

In addition, per Decree021-2017, Decree021-2017-Correct, and PER-72, the sponsor or the CRO must notify the DIIS, the ECs, and the PIs within a maximum period of seven (7) calendar days of any findings that could adversely affect the safety of research participants, have an impact on the conduct of the study, or alter the benefit/risk balance. This report should be prepared independently and separately from other required AE/AR submission deadlines outlined in this section. Decree021-2017, Decree021-2017-Correct, PER-4, and PER-12 further state that the sponsor or the CRO is also required to notify the DIIS of critical or very serious and major or serious deviations to the clinical trial protocol within a maximum period of seven (7) calendar days from the time of becoming aware of the incident.

The G-SafeRpt further explains that if the sponsor or the CRO is aware of safety findings that are not covered within the scope of an SAE/SAR or SUSAR, these findings require another measure or action such as a security emergency measure, an amendment to the protocol or informed consent, or the suspension or cancellation of the clinical trial. The sponsor should communicate this information to the DIIS through a detailed report that includes the measures and actions taken at the local and international levels, if already established. The ECs and PI should also be notified within seven (7) calendar days. The information must be written in Spanish and English, be contained in an electronic medium (CD), and be presented in the DIIS’s Document Processing Office. The sponsor is subsequently required to initiate administrative procedures that correspond to the measure or action taken, and in accordance with the requirements established by the clinical trial regulations. Refer to the G-SafeRpt for examples of administrative procedures.

As delineated in Decree021-2017, the G-SafeRpt, and PER-72, the sponsor is also required to submit, electronically on a quarterly or semi-annual basis, SAE/SAR and SUSAR reports occurring internationally, to the DIIS and the Council for International Organizations of Medical Sciences (CIOMS) whether they have occurred in the authorized trial, in other trials with the same IP, or in a context of different use. The G-SafeRpt specifies that the information should be presented on magnetic media. Refer to Annex 1 in the G-SafeRpt for data requirements. PER-72 further indicates that the sponsor should send the SUSAR reports for events that have occurred abroad as soon as possible to the investigator using CIOMS Form I (PER-18). The investigator, in turn, will send the reports to the EC. Further, per Decree021-2017, the DIIS must notify the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)) of any SAEs/SADRs and SUSARs caused by an IP being used in an authorized trial in Peru within a maximum period of 15 working days after receiving notification about the incident. The INS-CTManual also indicates authorized ANM personnel will have access to SAEs/SADRs and SUSARs that have occurred in Peru via REAS-NET (PER-69). (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)) (PER-109)). See also the G-CTSafety for information on actions taken by the INS’s DIIS in response to SAEs/SARs, SUSARs, and safety reports.

Other Safety Reports

As delineated in the INS-CTManual and the G-SafeRpt, the sponsor or the CRO must also submit an annual IP safety report (DSUR) to the DIIS. Decree021-2017 further specifies that the DSUR should be sent to the DIIS and the ANM. Per the INS-CTManual, the translation of the annual report summary must be presented in English and Spanish. The G-SafeRpt explains that the DSUR should be prepared after the first authorization of the clinical trial in any country. This is referred to as the Development International Birth Day (DIBD). The report should comply with the ICH Harmonised Tripartite Guideline: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A) (PER-52). The sponsor must complete form FOR-OGITT-048 (PER-45) online in Spanish as well as submit a copy of the DSUR to the DIIS on CD.

In addition, per the G-SafeRpt, the sponsor or the CRO must describe in the protocol the SAEs that will not be reported promptly because they are expected to occur in the study population with a frequency independent from their exposure to the IP. The sponsor or the CRO is also required to describe in the protocol the procedures for monitoring SAEs produced by the IP. Moreover, depending on the trial design, the pathology, and the IP, the sponsor or the CRO will describe in the protocol the notification procedures for non-serious AEs. Decree021-2017 also notes that the sponsor or the CRO should continuously evaluate IP safety and implement an IP security monitoring system.

According to the INS-CTManual and the G-SafeRpt, in cases of prenatal exposure due to a pregnant woman’s participation in a clinical trial, the PI, the sponsor or the CRO is required to submit form FOR-OGITT-047 (PER-39) to notify the DIIS of the SAE/SAR or SUSAR. Per the G-SafeRpt, the sponsor submits the form and the procedures for monitoring and controlling the pregnancy and newborn on magnetic media. The notification of a pregnancy must be made within seven (7) calendar days. The INS-CTManual also indicates prenatal monitoring reports must also be prepared during pregnancy, childbirth, and for six (6) months postpartum following the occurrence. See the Pregnant Women, Fetuses & Neonates section for additional information on this population.

See Decree021-2017, the INS-CTManual, the G-SafeRpt, and PER-38 for detailed sponsor/CRO reporting requirements.

Form Completion & Delivery Requirements

As per Decree021-2017, the INS-CTManual, the G-SafeRpt, and PER-72, all AEs/ARs, SAEs/SARs, and SUSARs must be reported electronically by the sponsor or the CRO using REAS-NET (PER-69). PER-12 specifies that notifications of very serious and major or serious protocol deviations should be submitted using FOR-OGITT-053 (PER-40) via the INS’s Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) (PER-89) (also referred to as REPECv2). PER-114 further notes that reports of SAEs (REAs) and deviations can be submitted via PER-89, regardless of the year of trial authorization. However, REAs and deviations that have been submitted via the older REPECv1 platform (PER-91) will remain on this platform for consultation, if required.

(Refer to PER-38 for the DIIS SAE/SAR form, FOR-OGITT-046. All SAEs/SARs and SUSARs must also be reported on the CIOMS Form I (PER-18). The INS-CTManual further notes that the sponsor or the CRO should also submit a printed copy of the CIOMS report in Spanish or English to the INS’s DIIS.

Pursuant to the G-SafeRpt, to report post-study AEs, the sponsor or the CRO should send an email to consultaensayos@ins.gob.be to coordinate with the person in charge of computer systems and grant the person access to REAS-NET (PER-69) to complete and submit the online form FOR-OGITT-046 (PER-38). SAEs/SAR notifications following a trial’s completion should remain in the research site archives.

Serious Adverse Events Report

V-VII and Annex 1

Chapter VI (6.4), VII (7.8.1-7.8.3), and Annex 4 (Flowcharts No. 12-14)

I, VII (7.1), and VIII (8.4)

Title I (Article 2), Title IV (Articles 40 and 52), and Title IX (Articles 108-111)

Last content review/update: March 21, 2024

Safety Reporting Definitions

In accordance with ClinImprtOrdr, ClinSampleProd, G-AEReptReqs, and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (THA-28), the following definitions provide a basis for a common understanding of Thailand’s safety reporting requirements:

Adverse Event (AE) – Any untoward or unfavorable medical occurrence in a research participant to whom a drug product was administered, and which does not necessarily bear a causal relationship to the treatment
Adverse Drug Reaction (ADR) – All dangerous and adverse reactions resulting from any dose of an investigational drug, for which it is at least reasonably likely that the adverse reaction is attributable to the drug being studied, that is, a relationship cannot be ruled out
Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (SADR) – Any untoward medical occurrence that at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
Suspected Unexpected Serious Adverse Reaction (SUSAR) – An unexpected SAE/SADR given the nature of the research procedures and the population being studied
Unexpected Adverse Event/Adverse Drug Reaction – A reaction where the nature or severity is inconsistent with the applicable product information

Per an in-country subject matter expert, Thailand is implementing THA-28. THA-28 also notes that the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A) (THA-26) should be referenced for additional safety terms not defined in this list.

Safety Reporting Requirements

Investigator Responsibilities

As stated in G-AEReptReqs, the principal investigator (PI) is responsible for reporting all SAEs/SADRs to the sponsor and the ethics committee (EC) no later than 24 hours after the PI becomes aware of the event. The PI must also report all AEs/ADRs to the sponsor and the EC no later than seven (7) calendar days following first knowledge.

For safety reporting requirements specific to the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH) and the Central Research Ethics Committee (CREC), please see THA-13 and THA-37 respectively.

Sponsor Responsibilities

As delineated in THA-28, sponsors who are permitted to import or order drugs for research in Thailand and those who are licensed to produce drug samples for human research studies, must comply with the Thai Food and Drug Administration (Thai FDA)’s safety monitoring and reporting requirements. ClinImprtOrdr and ClinSampleProd state that the following information is viewed as urgent and is required to be reported:

SAEs/SADRs that never occurred before because the research team used safety reporting information from other countries to substantiate investigational product (IP) use
Other safety and security information useful to evaluating IP risk-benefit assessment, IP changes to the method of administration, or changes required to the overall research process
Unexpected SAE/SADR incidents that never occurred before, with an increased incidence or severity and considered to be of clinical importance
Significant harm to the participant, such as the ineffectiveness of an IP used to treat a life-threatening disease
Significant new information about experimental animal safety studies, such as carcinogenicity

Per ClinImprtOrdr and ClinSampleProd, an ADR report must be filed in the following specified timelines:

Unexpected SAEs/SADRs that are fatal or life-threatening must be reported to the Thai FDA within seven (7) days from the first knowledge of the incident’s occurrence. Any additional relevant information should be sent within eight (8) days of the initial report
Unexpected SAEs/SADRs that are not fatal or life-threatening must be reported to the Thai FDA within 15 days from the date of SAE/SADR notification. A report must also be submitted periodically with any additional information.
AEs/ADRs that occur following the research participant’s participation in the study or after the study has been completed must be reported within 15 days from first knowledge of the event

According to G-AEReptReqs and G-ResEthics, the sponsor is also required to report all SUSARs to the EC as soon as possible, but no later than seven (7) calendar days for all fatal or life-threatening events, and no later than 15 calendar days for any non-fatal or non-life-threatening events. The sponsor must include the main points of concern. In addition, the sponsor must report to the EC any other non-local adverse reactions that may increase risks to participants within 15 days. Additionally, the sponsor must report any non-local SAEs/SADRs including SUSARs at least every six (6) months to the EC.

G-ResEthics and THA-28 state that the sponsor is responsible for expediting the reporting of all SUSARs to the investigator(s)/institution(s) participating in the trial, the EC(s), and to the Thai FDA. These reports should comply with G-AEReptReqs and the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A) (THA-26). See G-AEReptReqs for detailed reporting requirements for the investigator and sponsor.

Other Safety Reports

THA-28 indicates that the sponsor should submit to the Thai FDA all safety updates and periodic reports as required by applicable regulatory requirements. The sponsor is also responsible for the ongoing safety evaluation of investigational drug(s) and should promptly notify all concerned parties of findings that could adversely impact the safety of research participants, the conduct of the trial, or alter the EC’s approval or favorable opinion to continue the trial.

Per ClinImprtOrdr and ClinSampleProd, annual and end of study safety reports must be provided to the New Drugs and Drug Research Promotion Group within the Thai FDA’s Medicines Regulation Division. The annual report must be submitted as a document within three (3) months of the one (1) year anniversary of the study, and the final safety report must be submitted as a document within six (6) months after the study has concluded. In addition, a list of all SAE/SADR incidents involving research participant(s) should be included in the annual report. A detailed summary table with the number of SAEs/SADRs organized by terminology (symptoms and diagnosis) should be provided. See Appendix 21 in ClinImprtOrdr (Appendix 21 in THA-18) and Appendix 17 in ClinSampleProd (Appendix 17 in THA-76) for an example of the reporting form.

ClinImprtOrdr and ClinSampleProd further notes that other reports must be made in writing with information such as summary of risk assessment issues and related details for submission to the New Drugs and Drug Research Promotion Group.

Form Completion & Delivery Requirements

As per G-AEReptReqs, all SAEs/SADRs and SUSARs must be reported on the Thai FDA’s Health Product Vigilance Center (HPVC) (THA-30) SAE reporting form (THA-22) or the Council for International Organizations of Medical Sciences (CIOMS)’ form (THA-20). According to THA-37 and THA-20, AEs/ADRs and SAEs/SADRs must be reported to the Thai FDA. THA-22 indicates that the SAE form should be sent to the HPVC via mail, fax, or email at:

Health Product Vigilance Center
Food and Drug Administration
Ministry of Public Health
88/24 Tiwanon Road
Nonthaburi 11000
Thailand

Fax: 02 590 7253 or 02 591 8457
Email: adr@fda.moph.go.th

Pursuant to ClinImprtOrdr and ClinSampleProd, individual reports should be submitted electronically via the Thai FDA’s HPVC (THA-30), unless the system is unavailable. The report may also be submitted as a document to the New Drugs and Drug Research Promotion Group within the Thai FDA’s Medicines Regulation Division.

Individual report data should include at minimum the following information:

Research participant information for those that can be identified (e.g., participant codes)
Investigational drugs used in research study
AE/ADR symptoms or results suspected of being connected to the drugs
Source of follow-up reports
Research project code or name
Reporting numbers (e.g., report number specified by sponsor)

Per ClinImprtOrdr and ClinSampleProd, for research studies involving participants whose identities are disclosed, submitted AE/ADR reports should include the participant codes unless the Thai FDA’s Office of the Board of Directors deems it necessary to reveal the code immediately.

Ethical Criteria

Appendix 17

Appendix 21

II

1.1-1.2, 1.50, 1.60, 5.5, and 5.17

CREC 11 / v.4.0 Review of Adverse Event Reports

Annex 5 (17)

Descriptions and Definitions, 1, 2, 4, and Appendices 1-4

4.6 and Appendix 17

4.6 and Appendix 21

Progress Reporting

Last content review/update: April 24, 2024

Interim and Annual Progress Reports

National Institute of Health (INS)

As delineated in Decree021-2017, the INS-CTManual, PER-72, PER-47, PER-8, and PER-14, the sponsor or the contract research organization (CRO) must submit a progress report for each institution in which a trial is conducted from the date of the study’s authorization to the Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) (formerly known as the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT))) within Peru’s National Institute of Health (Instituto Nacional de Salud (INS)). The report should be submitted quarterly or biannually to the INS’s Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) (PER-89) (also referred to as REPECv2) for each of the approved research sites. Per the INS-CTManual, this report should be submitted regardless of the enrollment status in each site. The INS-CTManual and PER-14 further specify that the submission deadline is up to seven (7) calendar days after completing the quarterly or half-yearly period. The sponsor or the CRO should print and sign the electronic form and deliver it to the INS’s Document Processing Office within 20 working days. Refer to the INS-CTManual for additional information, and PER-47 and PER-8 for the progress report form and detailed submission instructions.

PER-92 further notes that while the older REPECv1 platform (PER-91) is closed for the entry of progress reports, research center final reports, national final reports, and international final reports, the reports will remain in the system for consultation.

In addition, Decree021-2017 and PER-72 state that the progress report must be sent in print and electronic media, and include the following information:

Number of patients enrolled in the study and status (e.g., in treatment, retired from study, completed study, or who are not ready to enroll) (Decree021-2017)
Summary of serious adverse events/adverse reactions (SAEs/SARs) and non-serious adverse events (AEs)/adverse reactions (ARs) related to the investigational product (IP), and deviations occurring in the corresponding period (Decree021-2017)
Number of patients who failed the screening (PER-72)
Number of patients with clinical failure (PER-72)

According to PER-72, the following documentation should also be attached to the progress report:

Quarterly or half-yearly report of deviations/breaches to the protocol that occurred during the stated timeframe for every research site
Quarterly or half-yearly report of the serious and unexpected adverse reactions (SUSARs) related to the IP that have occurred abroad

Ethics Committees

As per Decree021-2017, the principal investigator (PI) is also responsible for submitting clinical trial progress and final reports to the research institution and the institutional ethics committee (EC) (El Comité Institucional de Ética en Investigación (CIEI)).

Res233-2020, which regulates human subjects research other than clinical trials of drugs or devices, indicates that researchers should submit progress reports, final reports, suspension reports, and early termination reports, among others, to the EC per the terms established by the committee.

Final Report

As delineated in Decree021-2017, the INS-CTManual, PER-72, PER-48, PER-16, and PER-14, the sponsor or the CRO must submit a research site final report via PER-89 for each of the participating sites for a specific clinical trial within 30 calendar days following the closing visit made by the monitor. Per the INS-CTManual, this information should be provided regardless of the enrollment status of each site. The INS-CTManual notes that the electronic form should also be printed and signed by the sponsor or the CRO and delivered to the INS’s Document Processing Office within 20 working days. Refer to the INS-CTManual for additional information, and PER-48 and PER-16 for the final report form and detailed submission instructions.

Decree021-2017 also states that the final report should include the following information:

Number of screened, enrolled, and retired patients who completed the trial
Summary of SAEs/SARs and non-serious AEs/ARs related to the IP, and deviations occurring since the date of the last progress report

National Final Reports

Per Decree021-2017, Decree021-2017-Correct, the INS-CTManual, PER-72, and PER-14, national final reports should be submitted via PER-89 for the INS’s DIIS review within 60 calendar days following the date of the final report submission of the last research site. Per the INS-CTManual and PER-72, the national final reports should be electronically submitted (refer to PER-49 and PER-17 for the submission form and instructions).

For clinical trials performed only in Peru, the report must be submitted within a maximum period of six (6) months following the trial’s conclusion as indicated in Decree021-2017, Decree021-2017-Correct, the INS-CTManual, and PER-72. The DIIS will send a copy of the final national report of clinical trials to the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)) within 30 business days following receipt of the report. (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)) (PER-109)).

Per the INS-CTManual, the electronic form should also be printed and signed by the sponsor or the CRO and delivered to the INS’s Document Processing Office within seven (7) working days. If applicable, a report of the study results and conclusions must be attached as established in the INS-CTManual. Refer to the INS-CTManual for additional information, and PER-49 and PER-17 for the national final report form and detailed submission instructions.

Decree021-2017 further explains that the national final report should include the following information:

Number of screened, enrolled, retired patients who completed the trial
Summary of SAEs/SARs and non-serious AEs/ARs related to the IP, and deviations that occurred
For trials performed only in Peru, the report should also include the final results and conclusions of the trial

International Final Reports

As delineated in Decree021-2017, the INS-CTManual, and PER-72, international final reports should be submitted to PER-89 within 12 months following the completion of the last clinical trial in all international research sites. Per the INS-CTManual, the sponsor or the CRO should also print and sign the electronic form and deliver it to the INS’s Document Processing Office within 20 working days. In addition, a report of the study results and conclusions should be attached as established in the INS-CTManual. PER-72 notes that the report should include the results and the study conclusions before publication. Refer to the INS-CTManual for additional information, and PER-46 and PER-9 for the international final report form and detailed submission instructions.

Results Publication

Further, according to Decree021-2017, the INS, in coordination with the sponsor, must submit a Results Publication after the final national or international report is completed to provide the results of authorized and performed clinical trials through PER-89 using form FOR-OGITT-058 (PER-23). The sponsor is also obligated to submit an article to a national or international scientific journal that strictly reflects the final report submitted to the DIIS and notify DIIS of this submission using form FOR-OGITT-059 (PER-41). The published article must also be sent to the INS and the research institution in print and electronic media.

Clinical Trial Progress Report and Final Reports

Chapter VII (7.13.3-7.13.5) and Annex 4 (Flowcharts No. 25 and 30-32)

I, VII (7.1), and VIII (8.4)

Title I (Article 2), Title IV (Articles 40 and 52), and Title VIII (Articles 104-107)

Last content review/update: March 21, 2024

Interim and Annual Progress Reports

As delineated in G-ResEthics, the investigator(s) must submit progress reports on the status of the trial to the ethics committee (EC) at the designated interval (not specified). For high-risk research protocols, investigator(s) should report the progress more frequently than for a low-risk protocol. The investigator should also provide a proposed schedule to submit a progress report to the EC from the date of protocol submission for ethical review, which should be at least once a year.

The International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (THA-28) further notes that investigator(s) should submit a research summary report in writing to the EC once a year, or more often, as required by the EC. Investigator(s) should send a written report to the EC and the institution, if applicable, regarding any changes that may impact the research process and/or cause increased risk to the research participants. Per an in-country subject matter expert, Thailand is implementing THA-28.

In addition, according to ClinImprtOrdr and ClinSampleProd, the sponsor must submit a study progress report annually to the Director of the Thai Food and Drug Administration (Thai FDA)'s Medicines Regulation Division between October 1 and 31 every year until the study ends. Per ClinImprtOrdr, for N.Y.M.1/investigational product (IP) import applications, this report should be submitted using the progress report form in Appendix 15 in THA-18, and accompanied by a delivery letter to the Thai FDA’s Director of the Bureau of Medicine using the format in Appendix 14 in THA-18. Per ClinSampleProd, for P.Y.8/IP sample production applications, the report should be submitted using the progress report form in Appendix 11 in THA-76, and accompanied by a delivery letter to the Thai FDA’s Director of the Bureau of Medicine using the format in Appendix 10 in THA-76.

Requests that already have information in the FDA’s Skynet E-Submission System (THA-54) must submit documents according to the system’s procedures. See Submission Process section for detailed information on submitting information via the FDA’s Skynet E-Submission System (THA-54).

Final Report

As specified in ClinImprtOrdr, in the event of early termination of the research study, the sponsor must submit a summary report (Appendix 19 of ClinImprtOrdr) to the Thai FDA within 60 days after the closeout of the last study site.

G-ResEthics also requires investigator(s) to submit a final report to the EC upon the trial’s termination.

For reporting requirements specific to the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH), please see THA-13. Also, refer to THA-37 for Central Research Ethics Committee (CREC) reporting requirements. The ECMOPH and the CREC are both ECs recognized by the Thai FDA to review and approve clinical trial protocols.

Individual ECs should be contacted to confirm their specific requirements.

Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (Revised 2007) (p. 72); Additional Resolution of the Committee (2005) (p. 76); Additional Resolution of the Committee (2006) (p. 80)

Appendices 10-11

Appendices 14-15 and 19

4.10

CREC 12 / v.4.0 Review of Close Study Reports; CREC 13 / v.4.0 Management of Study Termination Report

6.6

4.1 and Appendices 10-11

4.1 and Appendices 14-15 and 19

Definition of Sponsor

Last content review/update: April 24, 2024

Decree021-2017 defines a sponsor as an individual, group of individuals, company, institution, or organization with legal representation in the country, and duly registered in the corresponding public registries. The sponsor takes ultimate responsibility for trial initiation, maintenance, conclusion, and financing. When an independent researcher initiates and takes full responsibility for a clinical trial, then the role of sponsor is assumed.

Decree021-2017 also states that sponsors not based in Peru are required to appoint a legal representative who channels all the communication with the Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) (formerly known as the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT))) within Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) for the trial’s duration.

Decree021-2017 also explains that a sponsor can authorize a contract research organization (CRO) with legal status and an office in Peru to carry out certain work and obligations regarding the trial. However, the sponsor is ultimately responsible for the execution of the research protocol and the results of the trial.

Title IV (Articles 41-45)

Last content review/update: March 21, 2024

In accordance with G-ResEthics, and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (THA-28), a sponsor is defined as an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. Per an in-country subject matter expert, Thailand is implementing THA-28.

Per G-ResEthics and THA-28, the Thai government also permits a sponsor to authorize a contract research organization (CRO) to perform one (1) or more of a sponsor’s trial-related duties and functions. However, the ultimate responsibility for the trial data’s quality and integrity always resides with the sponsor. Any trial-related responsibilities to be transferred and assumed by a CRO should be specified in a written agreement or contract. A sponsor may be domestic or foreign.

Per THA-65 and THA-77, although applicants residing outside Thailand cannot register directly with Digital ID (THA-89), they can request permission to authorize a juristic person who receives power of attorney to use the OSSC’s online consultation system (E-Consult) (THA-77) and to submit applications to the FDA’s Skynet E-Submission System (THA-54).

THA-28 also states that the sponsor may be a sponsor-investigator if the individual both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered or dispensed. The sponsor-investigator’s obligations include both those of a sponsor and those of an investigator.

According to THA-13, the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH) requires the sponsor and/or CRO to be legally registered in Thailand. The ECMOPH is one (1) of the ethics committees approved by the Thai Food and Drug Administration (Thai FDA) to approve clinical research protocols. See THA-13 for additional ECMOPH sponsor requirements.

Per ClinImprtOrdr, the sponsor is also referred to as the applicant or importer, and in ClinSampleProd, the sponsor is also referred to as applicant.

Additional Resolution of the Committee (2005) (p. 76) and Additional Resolution of the Committee (2006) (p. 77)

Requirements before using the E-consult system, Applying for service

1.20, 1.53-1.54, and 5.2

Annex 5

Site/Investigator Selection

Last content review/update: October 31, 2024

Overview

Per Decree021-2017, the National Institute of Health (Instituto Nacional de Salud (INS))’s Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) (formerly known as the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT))), follows the requirements provided in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (PER-53) for topics not addressed in Decree021-2017. Accordingly, PER-53 states that the sponsor or the contract research organization (CRO) is responsible for selecting the investigator(s) and the institution(s) for the clinical trial, taking into account the appropriateness and availability of the study site and facilities. Investigators should also be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial. Decree021-2017 further specifies that, in addition to professional competence, the sponsor or the CRO should also ensure that investigators have enough time to conduct the trial and agree to comply with good clinical practices (GCP) and ethical standards. Res233-2020 also requires investigators to have basic training in ethical research with human beings. PER-53 may also be referred to for additional information on investigator requirements.

Per Decree021-2017 and Res655-2019 (which amends Decree021-2017), research institutions must also register with the INS’s Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) (PER-89) (also referred to as REPECv2), but are no longer required to provide proof of this registration in the clinical trial authorization application. As delineated in Res655-2019, the research institution’s legal representative must submit an application for registration that includes the following:

A code from the National Registry of Institutions that Provide Health Services (Registro Nacional de Instituciones Prestadoras de Servicios de Salud (RENIPRESS)) (Refer to PER-80 for instructions on how to register a health service provider institution in RENIPRESS.)
Details of the categorization level assigned to the health institution interested in obtaining registration as a research center to conduct clinical trials (per Res546-2011, categorization is based on the institution’s levels of complexity and functional characteristics)
Number and date of proof of payment of processing fees

Decree021-2017 also requires research centers to register with REPEC (PER-89) to carry out clinical trials at the research institution’s request. According to PER-73, research centers should apply electronically via REPEC (PER-89), submit the printed application form, FOR-OGITT-022 (PER-19) per Res0423-2019, and complete the printed affidavit form, FOR-OGITT-023 (PER-44). Research center registration is valid for three (3) years. Refer to PER-73 for detailed registration instructions and PER-90 for a research center registration checklist. According to PER-73, public and private sector research centers must also be registered in (REPEC) (PER-89), at the request of the research institution, to carry out clinical trials.

Per PER-113, the INS’s DIIS has established the Validity of the Record of Registration of Research Center in compliance with Law1452 (which amends Law27444). In accordance with Law1452, any Research Center Registration Certificate (Constancia de Registro de Centros de Investigación (RCI)) that is valid as of September 16, 2018, and all those certificates subsequently issued, are valid for an indefinite period, and are therefore exempt from the registry renewal process delineated in Decree021-2017. However, the DIIS may continue to carry out subsequent scheduled or unscheduled audits in accordance with its authority, and may revoke the certificate, if it verifies changes in the conditions essential to obtaining the registration.

PER-131 further states that the RCIs are no longer valid for research centers that do not have active clinical trials and whose RCI was issued prior to September 16, 2015. Research institutions that intend to continue carrying out clinical trials may request an update of the RCI validity by completing and signing the printed application form, FOR-OGITT-022 (PER-19), and affidavit form, FOR-OGITT-023 (PER-44), and submitting via REPEC (PER-89). Research institutions must also notify the Virtual Submission Platform (Mesa de Partes Virtual (MPV)) (PER-106) of the submitted procedures, and attach PER-19 and PER-44. Additionally, as indicated in PER-130, sponsors or CROs are obligated to verify that the research center where a clinical trial will be conducted is authorized in the specialty related to the proposed trial. If the research center did not provide the related specialty information in its REPEC registration, the research institution’s legal representative, as research center administrator, must submit a request to the INS’s DIIS to modify the registration to include the required specialty. The new RCI must also include the required specialty. All of these procedures must be carried out prior to the request for authorization of a clinical trial.

Foreign Sponsor Responsibilities

Decree021-2017 states that the sponsor is required to appoint a legal representative in the country for the trial’s duration when based outside of Peru. Per Decree021-2017, the in-country legal representative channels all communication with the INS’s DIIS during the study’s execution, unless this responsibility is delegated to a CRO. As specified in Decree021-2017, the sponsor may transfer any or all of the study related duties and functions to a CRO. However, the sponsor is ultimately responsible for the execution of the research protocol and results of the clinical trial.

See PER-7 for detailed documentation submission requirements for a foreign sponsor to delegate an in-country legal representative or for a local sponsor to appoint a legal representative. Decree021-2017 further explains that the in-country representative must also be registered in REPEC (PER-89) for the trial’s duration. Refer to the Submission Process section for additional REPEC registration instructions.

Data and Safety Monitoring Board

Decree021-2017 requires the sponsor to provide data on the Data Safety Monitoring Board (DSMB) including its composition, a summary of its role and notification procedure, a statement of independence from the sponsor, and any conflicts of interest. Additionally, the sponsor should specify where to find other details about the by-laws not included in the protocol or explain why a DSMB is not necessary.

Multicenter Studies

Per Decree021-2017, multicenter clinical trials are carried out by more than one (1) investigator and require an appointed coordinator responsible for processing all of the data and analyzing the results.

In addition, according to PER-53, in the event of a multicenter clinical trial, the sponsor must ensure that:

All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor, and given ethics committee approval
The case report forms (CRFs) are designed to capture the required data at all multicenter trial sites
Investigator responsibilities are documented prior to the start of the trial
All investigators are given instructions on following the protocol, complying with a uniform set of standards to assess clinical and laboratory findings, and completing the CRFs
Communication among investigators is facilitated

In addition, the sponsor is responsible for the organization of a coordinating committee and/or selection of coordinating investigator(s), if they are to be utilized.

4.1, 5.6, and 5.23

Article 36-B

Article 35

VII (7.1) and VIII (8.4)

Annexes A and B

Preamble and Annex 1

Title I (Article 2), Title IV (Articles 40-42 and 53-54), Title VIII (Article 108), Supplementary Provisions—Final (First), and Annex 1

Last content review/update: March 21, 2024

Overview

In accordance with G-ResEthics and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28), the sponsor is responsible for selecting the investigator(s) and the institution(s) for the clinical trial, and for ensuring that the investigator(s) are qualified by training and experience. Per an in-country subject matter expert, Thailand is implementing THA-28. THA-14 also states that researchers must have basic knowledge in the field of research.

Additionally, per THA-28 and G-ResEthics, the sponsor must define and allocate all study related duties and responsibilities to the relevant parties participating in the study. Prior to entering into an agreement with the investigator(s) and the institution(s) to conduct a study, the sponsor should provide the investigator(s) with the protocol and an investigator’s brochure.

Foreign Sponsor Responsibilities

No information is available regarding foreign sponsor regulatory requirements.

Data Safety Monitoring Board

Although not specified as a sponsor requirement, G-ResEthics, G-AEReptReqs, and THA-28 encourage the establishment of a Data Safety Monitoring Board.

Multicenter Studies

As delineated in G-ResEthics and THA-28, in the event of a multicenter clinical trial, the sponsor must ensure that:

All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor, and if required, by the Thai Food and Drug Administration (Thai FDA), and are given ethics committee approval
The case report forms (CRFs) are designed to capture the required data at all multicenter trial sites
Investigator responsibilities are documented prior to the start of the trial
All investigators are given instructions on following the protocol, complying with a uniform set of standards to assess clinical and laboratory findings, and completing the CRFs
Communication between investigators is facilitated

3

1.25, 4.1, 5.1, 5.5, and 5.7

Annex 5 (5, 6, 7, and 23)

Descriptions and Definitions and Appendix 3

Insurance & Compensation

Last content review/update: April 24, 2024

Insurance

As set forth in Decree021-2017, the G-EC-CTRev, and PER-71, it is a legal requirement for the sponsor or the contract research organization (CRO) to carry a valid insurance policy for the expected duration of the study for any unforeseen injury to research participants. Per Res0423-2019, the sponsor or the CRO should sign an affidavit (PER-51) guaranteeing an active insurance policy is in place according to requirements in the INS-CTManual.

Decree021-2017 also specifies that the sponsor or the CRO must obtain insurance coverage in Peru or have a legal representative in Peru who will represent the sponsor or the CRO, if the policy is from a foreign company. The insurance policy must be in force until the date of submission of the National Final Report. At the end of this period, it should be renewed whenever there is still a possibility of late damages arising from the adjudication of injuries resulting from the clinical trial.

Compensation

Injury or Death

According to Decree021-2017 and PER-71, in addition to guaranteeing an active insurance policy is in place, the affidavit (PER-51) submitted by the sponsor or the CRO also certifies a financial fund is immediately and conveniently available. The fund ensures free medical treatment to participants who suffer any trial-related injuries as long as the insurance policy is activated.

In addition, as described in Decree021-2017, compensation will be awarded in the following circumstances:

Any damage to the research participant as a result of participation in the clinical trial
Any damage that occurred during pregnancy or that would have occurred to the newborn in the case of pregnancy in a female research participant or in the couple of the male research participant, as long as it is a result of their participation in the trial
Economic damages derived directly from earlier stated damages, provided that the damage is not inherent to the pathology under study, or to the individual evolution of the research participant

The sponsor’s obligation to award compensation is independent of the validity or available coverage of the contracted insurance.

Trial Participation

Per Decree021-2017, research participants may receive reasonable compensation from the sponsor for extraordinary expenses incurred and loss of productivity arising from their participation, which will be specified in the informed consent. The institutional ethics committee (EC) (El Comité Institucional de Ética en Investigación (CIEI)) will evaluate this form of compensation on a case-by-case basis and determine whether it unduly influences the consent of the research participant.

PER-15 further states the following:

Research participants may receive compensation in order to reimburse them for expenses (e.g., transportation, accommodation, communication, food expenses) and/or compensate the loss of productivity, time, among others, derived from their participation. Any compensation to the participants of the investigation must be reasonable and proportionate and, in no case, may it constitute undue influence.
In order to safeguard the rights of research participants, researchers and sponsors should take into account the personal and specific considerations of each research participant for the calculation of compensation for expenses incurred arising from their participation and,
ECs must evaluate the compensation amount, paying special attention to the information that appears in the informed consent forms, in order to ensure that the established compensations consider the possible conditions of each research participant

Post-Trial Access to the Investigational Product

As delineated in Decree021-2017, the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)) is also responsible for authorizing post-study access to the investigational product (IP) by study participants when it is demonstrated to be beneficial. ANM authorization is granted on a case-by-case basis through the following procedures:

Authorization of a clinical trial corresponding to a Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) (formerly known as the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT))) approved extension study
ANM authorization for an IP which must have proved to be beneficial to a participant, at the PI’s discretion, and its use will be maintained as soon as there is benefit

The PI should communicate to the sponsor the IP’s benefit to the participant, and the sponsor must, in turn, request ANM authorization (See Title X of Decree021-2017 for documentation submission requirements) (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)).

Decree021-2017 also notes that participants must be ensured free access to the IP following the trial’s conclusion. Before the study commences, post-study access should be anticipated, and this information must be provided during the informed consent process.

Ethical Criterion 5 and Annex 2

Chapters VII (7.14) and IX

Annex 1

Title I (Articles 2 and 8), Title III (Articles 27-29), Title III (34-35), Title IV (Article 40), Title X, and Annex 4

Last content review/update: March 21, 2024

Insurance

ClinImprtOrdr and ClinSampleProd specify that financing and insurance information should be included in the study protocol and protocol summary. If not included in the protocol and research project summary, a financial/insurance agreement should be attached separately in the application package as one (1) of the documents that the ethics committee (EC) considers approved or certified (e.g., Patient Information Sheets, etc.). G-ResEthics also states that the sponsor should provide insurance or indemnify the investigator/institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence, if required by applicable regulatory requirements.

Compensation

Injury or Death

As specified in ClinImprtOrdr, ClinSampleProd, G-ResEthics, G-CT-DIPApp, and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (THA-28), the sponsor or the designated contract research organization (CRO) is responsible for providing information related to compensation in the event of trial-related injuries or death to research participants and/or their legal heirs. ClinImprtOrdr further states that payment of compensation (if any) will be determined on a monthly basis to participants involved in the research. (See THA-18 and THA-76 for the forms included in the appendices in ClinSampleProd and ClinImprtOrdr.)

Per an in-country subject matter expert, Thailand is implementing THA-28. The sponsor must also inform the participants of any available medical treatment in the event of trial-related injuries. MCEthics further indicates that medical practitioners are responsible for harm or damage because the research studies involving the participant were not the fault of the participant.

Trial Participation

As per G-ResEthics, Phase I trial participants should be compensated for travel, loss of work, or other expenses incurred while participating in the trial.

Appendices 2 and 7

Appendices 3 and 11

4.8

3.2 and Annex 5 (8)

11

1.5, 1.10, and Appendices 2 and 7

1.3, 1.9-1.10, and Appendices 3 and 11

Chapter 9 (Article 49)

Risk & Quality Management

Last content review/update: April 24, 2024

Quality Assurance/Quality Control

As stated in Decree021-2017, the sponsor or the contract research organization (CRO) is responsible for ensuring that all information on the investigational product (IP) and additional documentation corresponds to the research protocol and complies with good clinical practices (GCPs) as provided in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (PER-53), as well as the requirements established in Decree021-2017. PER-53 further explains that the sponsor or the CRO is responsible for implementing and maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, PER-53, Decree021-2017, and other applicable regulatory requirements.

Declaration of the sponsor guaranteeing that the researchers will allow the monitoring, audits, supervision of the institutional ethics committee (EC) (El Comité Institucional de Ética en Investigación (CIEI)) and inspections of the clinical trial by the National Institute of Health (Instituto Nacional de Salud (INS))'s Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) (formerly known as the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT))), including direct access to the documentation of the clinical trial. Per Decree021-2017, the sponsor or the CRO is responsible for obtaining agreement from the investigators to ensure that they will allow monitoring, audits, ethics committee (EC) monitoring, and trial inspections by the DIIS, including direct access to the clinical trial documentation. PER-53 further states the sponsor is responsible for securing agreements from all involved parties to ensure direct access to all trial related sites, source data/documents, and reports for the purpose of monitoring and auditing by the sponsor and inspection by domestic and foreign regulatory authorities.

In addition, PER-53 states that the sponsor or the CRO should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. The quality management system should use a risk-based approach that includes:

During protocol development, identification of processes and data that are critical to ensure participant protection and the reliability of trial results
Identification of risks to critical trial processes and data
Evaluation of the identified risks against existing risk controls
Decisions on which risks to reduce and/or which risks to accept
Documentation of quality management activities and communication to those involved in or affected by these activities
Periodic review of risk control measures to ascertain whether the implemented quality management activities are effective and relevant
In the clinical study report, a description of the quality management approach implemented in the trial and a summary of important deviations from the predefined quality tolerance limits and remedial actions taken

Monitoring Requirements

As part of the clinical protocol requirements, Decree021-2017 notes that the following data collection and monitoring activities should be implemented:

Develop plans to evaluate and collect baseline, outcome, and other study data, including a process to improve data quality and a description of instruments used in the study along with their reliability and validity, if known
Prepare plans to promote participant retention and complete follow up, including a list of data to be collected from participants who leave the trial or deviate from it
Document (or provide) data monitoring committee details including its composition, a summary of its role and notification procedure, a statement of its independence from the sponsor, and its conflicts of interest. Details about by-laws not included in the protocol should be specified, or an explanation about why this committee is not needed
Describe trial monitoring arrangements/audits and sponsor’s statement to ensure that investigators will allow monitoring, audits, EC monitoring, and INS’s DIIS trial inspections, including direct access to clinical trial documentation
Provide plans to enter, encode, protect, and save data, including any process to improve its quality
Specify where data management procedure details not included in the protocol can be found

No specific timeframe is provided for the audit process.

The G-CTInspec explains that the INS’s DIIS inspection team carries out GCP inspections in accordance with Decree021-2017. Trial inspection findings are based on the severity of the clinical trial conditions, practices, or processes and their potential to affect adversely the rights, safety, or well-being of the research participants and/or data quality and integrity. Inspections are carried out through ordinary and extraordinary inspections, with qualified personnel (multidisciplinary, if applicable) and may be conducted at the beginning, the middle, or the end of the trial. Ordinary inspections are conducted according to the DIIS’s Annual Schedule of Ordinary Inspections. Extraordinary inspections are performed in response to a complaint received by phone, written communication, formal document submitted through the INS reception desk, or from any relevant information received through safety reports, progress reports, and/or a justified request by a clinical trial evaluation team that has obtained DIIS approval. If required, the DIIS coordinates with the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)) for the agency’s assistance in verifying compliance with good manufacturing practices standards, good storage practices, and other IP related standards. (Note: The ANM is also known as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)) (PER-109)).

In addition, during an inspection, the evaluation of biological samples is conducted in accordance with the provisions in Decree021-2017. Please refer to the G-CTInspec for detailed clinical trial inspection procedures. See also PER-100 for the clinical trial inspection sheet form (FOR-OGITT-049). The INS-CTManual and the G-CTInspec indicate that when a regulatory medicines agency of high health surveillance notifies a research site to carry out an inspection visit in Peru, the sponsor or the contract research organization (CRO) is required to inform the INS’s DIIS of the date and time of this visit within five (5) business days of receiving the notification. The DIIS will then coordinate with the regulatory medicines agency of high health surveillance to arrange for their participation in the inspection visit as an observer.

Per the INS-CTManual, for regular clinical trial inspections scheduled by the INS’s DIIS, when inspection findings are critical, the sponsor or the CRO is required to submit a defense within a period of no more than seven (7) working days following receipt of the inspection report. If the inspection observations are minor or major, the sponsor or the CRO should submit their defense within a period of no more than 15 working days, after receiving the inspection report. The inspector will issue an official notice of compliance within a period of no more than 15 business days if the sponsor or the CRO addresses the issues identified in the report in a timely way. Please refer to section 7.9 of the INS-CTManual for detailed information on preparing for the INS’s DIIS scheduled clinical trial inspections and responding to the inspection reports received.

Per Decree021-2017, Res064-2021, and the G-CTSanction, in the event of a DIIS inspection during which violations in the implementation of a clinical trial are identified, the sponsor or the CRO will be subject to the following sanctions: a warning(s) and a fine for the infraction(s). In addition to the warning(s) and fine, the sponsor will also be required to cancel the trial. See also G-CTFines for additional information on how fines are assessed and graded.

As explained in Res064-2021 and the G-CTSanction, once an investigation is initiated, the DIIS’s Clinical Trials Subdirectorate (Subdirección de Ensayos Clínicos) (formerly known as the Executive Office of Investigation (Oficina Ejecutiva de Investigación (OEI)) notifies the participant(s) responsible for conducting the trial of the possible sanction(s) and the charges being made. The participant(s) then has five (5) business days from the date of notification to dispute the charges. The Clinical Trials Subdirectorate may subsequently carry out an examination to determine the existence of the liability(ies) subject to sanction within a maximum period of 30 business days. A final instructional report by the Clinical Trials Subdirectorate is prepared within no more than 15 business days and submitted to the DIIS. Once the report is received, within a maximum term of 15 business days, the DIIS decides on the application of the sanction and may order the performance of complementary actions if considered essential to resolving the procedure. Within a term not exceeding 15 business days, the DIIS then issues a resolution that applies the sanction or the decision to archive the procedure and the participant will be notified. The participant has 15 business days to file an appeal to the DIIS which will then be resolved within 30 business days.

Premature Study Termination/Suspension

Decree021-2017 states that the sponsor or the CRO is responsible for submitting the required documentation to Peru's INS to request a trial’s suspension. Per Decree021-2017 and Res655-2019 (which amends Decree021-2017), an application must be submitted that substantiates the reasons for the suspension and describes the data obtained until the time of the suspension. Refer to PER-43 for the clinical trial research site closure application form, PER-30 for the clinical trial suspension application form, and PER-31 for the clinical trial cancellation request form.

1.46-1.47 and 5.0-5.1

2 and 4.3-4.4

6.2 and 7.5

Chapter VII (7.9)

2 and 4.3-4.4

Annexes A and B

Title I (Article 2), Title IV (Article 40), Title V (Article 83), Supplementary Provisions—Final (First), and Annex 1

Last content review/update: March 21, 2024

Quality Assurance/Quality Control

As stated in ClinImprtOrdr, ClinSampleProd, and G-ResEthics, the sponsor is responsible for implementing and maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data are generated, recorded, and reported in compliance with the protocol and the International Council for Harmonisation (ICH)'s Guideline for Good Clinical Practice E6(R2) (THA-28). Per an in-country subject matter expert, Thailand is implementing THA-28.

G-ResEthics and THA-28 explain that the sponsor is required to obtain agreement from all involved parties to ensure direct access to all trial related sites, source data/documents, reports for monitoring and auditing purposes, and inspection by domestic and foreign regulatory authorities.

G-ResEthics and THA-28 further specify that the sponsor must also obtain the investigator(s) and the institution(s) agreement to:

Conduct the trial in compliance with THA-28, applicable regulatory requirement(s), and the protocol agreed to by the sponsor and approved by the ethics committee (EC)
Comply with data recording and reporting procedures
License monitoring, auditing, and inspection
Retain essential documents until the sponsor informs them that they are no longer needed

Any agreements should be made in writing and the sponsor should sign the protocol, or a separate agreement.

Pursuant to G-ResEthics and THA-28, QC should be applied to each stage of data handling to ensure that all data are reliable and have been correctly processed. In addition, per THA-28, the sponsor should focus on trial activities essential to ensuring participant protection and the reliability of trial results. The quality management system should also use a risk-based approach that includes:

During protocol development, identify processes and data that are critical to ensure participant protection and the reliability of trial results (Critical Process and Data Identification)
Identify risks to critical trial processes and data (Risk Identification)
Evaluate the identified risks against existing risk controls (Risk Evaluation)
Decide which risks to reduce and/or which risks to accept (Risk Control)
Document quality management activities and communicate to those involved in or affected by these activities (Risk Communication)
Periodically review risk control measures to ascertain whether the implemented quality management activities are effective and relevant (Risk Review)
In the clinical study report, describe the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken (Risk Reporting)

ClinImprtOrdr states that the trial must be conducted in accordance with the Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) principles.

Monitoring Requirements

G-ResEthics and THA-28 note that the sponsor may choose to perform a clinical trial audit as part of its QA system. The purpose of the audit should be to evaluate trial conduct and compliance with the protocol, SOPs, and other applicable regulatory requirements. The sponsor should ensure that the auditors are qualified by training and experience, and the auditor’s qualifications should be documented. The sponsor must also ensure that the audit is conducted in accordance with the SOPs, the auditor observations are documented, and data are available as needed for the Thai Food and Drug Administration (Thai FDA). No specific timeframe is provided for the audit process.

Per ClinImprtOrdr, the sponsor and investigator must facilitate the Thai FDA’s monitoring of the clinical trial to ensure compliance with GCP and GLP, safety reporting, and progress reporting requirements.

In addition, per THA-28, the sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The extent and nature of monitoring is flexible and permits varied approaches that improve effectiveness and efficiency. The sponsor may choose onsite monitoring, a combination of onsite and centralized monitoring, or, where justified, centralized monitoring. The sponsor should document the rationale for the chosen monitoring strategy (e.g., in the monitoring plan). See THA-28 for detailed information on the sponsor’s role in developing monitoring systems.

Premature Study Termination/Suspension

G-ResEthics and THA-28 state that if a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigators/institutions and the regulatory authority(ies) of the termination or suspension and the reason(s) for the termination or suspension. The sponsor or the investigator/institution should also promptly inform the EC and provide the reasons for the study’s termination or suspension.

G-CT-DIPApp also specifies that in the event of the premature discontinuance of a trial, the Thai FDA must be notified no later than 30 working days after the date of discontinuance. G-CT-DIPApp further notes that a corresponding notification letter referring to the related approved import license along with supplemental documents as indicated in Appendix 13 is needed, and a corresponding notification letter along with supplement documents as indicated in Appendix 14 is needed. (Note: Appendices 13 and 14 as referenced in G-CT-DIPApp are only available in the ClinImprtOrdr.) As stated in ClinImprtOrdr and ClinSampleProd, at the conclusion or termination of a clinical trial, a summary report must also be submitted within 60 days after the closeout of the last study site. ClinImprtOrdr and ClinSampleProd further explain that details of remaining medicines to be destroyed and evidence supporting the destruction or return of the study drugs should also be included (Appendix 20 in ClinImprtOrdr and Appendix 16 in ClinSampleProd each contain a sample notification form required to be completed when terminating a research project). (See also THA-18 and THA-76 for the forms included in the appendices in ClinSampleProd and ClinImprtOrdr.)

Per G-CT-DIPApp, after the import license is granted, the applicant must also notify the Thai FDA when the clinical trial has been discontinued in its entirety or at any clinical trial site for reasons not related to the safety of clinical trial, or if the trial has been discontinued prematurely.

Appendices 7 and 16

Appendices 2, 5, 7-11, 13-14, 16-18, and 20

1.65, 4.9, 4.12, 5.0-5.1, 5.5-5.6, 5.18-5.19, 5.21, 5.23, and 6.10

Annex 5 (1, 5, 6, 19, and 21)

16.2

1.8-1.10, 2, 4.5, and Appendices 7 and 16

1.6-1.7, 1.10-1.11, 4.2, and Appendices 2, 5, 7-11, 13-14, 16-18, and 20

Data & Records Management

Last content review/update: April 24, 2024

Electronic Data Processing System

No information is currently available.

Records Management

As set forth in Decree021-2017, the sponsor or the contract research organization (CRO) is required to possess a documented monitoring record, including the provision of specially selected and specialized personnel (monitors). Additionally, the sponsor or the CRO is responsible for filing in the country all documentation and data obtained for at least 10 years after the conclusion of the study. After two (2) years, the documentation/data may be filed electronically, after communication with the National Institute of Health (Instituto Nacional de Salud (INS)).

Per Decree021-2017, Peru also complies with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (PER-53), which provides guidance to sponsors on records management. PER-53 further specifies that sponsor-specific essential documents should be retained until at least two (2) years after the last approval of a marketing application, until there are no pending or contemplated marketing applications, or at least two (2) years have elapsed since the formal discontinuation of the investigational product’s clinical development. The sponsor should inform the investigator(s) and the institution(s) in writing when trial-related records are no longer needed.

In addition, PER-53 states that the sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should allow for document identification, version history, search, and retrieval. The sponsor should ensure that the investigator has control of and continuous access to the data reported to the sponsor. The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.

5.5 and 8.1

Title I (Article 2), Title IV (Article 40), and Supplementary Provisions—Final (First)

Last content review/update: March 21, 2024

Electronic Data Processing System

Per G-ResEthics and THA-28, when using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance, and that standard operating procedures are maintained for using these systems. Per THA-28, the sponsor’s approach to validate such systems should be based on a risk assessment that takes into consideration the intended use and the potential of the system to affect participant protection and reliability of trial results. Refer to G-ResEthics and THA-28 for detailed information on electronic trial data systems. ClinImprtOrdr and ClinSampleProd also note that sponsors should ensure that research facilities are prepared for inspections by the Thai Food and Drug Administration (Thai FDA) by ensuring that research participant source data and case report forms are stored in electronically based data collection systems.

Records Management

As set forth in G-ResEthics and THA-28, sponsor-specific essential documents should be retained until at least two (2) years after the last approval of a marketing application in an International Council for Harmonisation (ICH) region, until there are no pending or contemplated marketing applications, or at least two (2) years have elapsed since the formal discontinuation of an investigational product’s clinical development. The sponsor should inform the investigator(s) and the institution(s) in writing when trial-related records are no longer needed.

In addition, THA-28 states that the sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should allow for document identification, version history, search, and retrieval. The sponsor should ensure that the investigator has control of and continuous access to the data reported to the sponsor. The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.

5.5 and 8

Annex 5 (5)

4.7

Personal Data Protection

Last content review/update: April 24, 2024

New Info (Not Yet in Profile)

Approved by Supreme Decree No. 016-2024-JUS, the Regulation of Law No. 29733 – Personal Data Protection Law went into effect on March 30, 2025. The Regulation establishes provisions for the proper application of the Personal Data Protection Law by natural persons, public entities, and private sector institutions and applies to all forms of personal data processing, regardless of the medium on which they are stored. Furthermore, the Regulation requires companies or organizations to designate a Data Protection Officer (DPO) on a progressive schedule based on size.

Responsible Parties

Law29733 provides that the “person in charge of the personal data bank” is any natural person, private legal entity, or public entity that, alone or acting in conjunction with another, performs the processing of personal data on behalf of the owner of the personal data bank. Law1353 and Decree003-2013 modify the definition provided by Law29733 by stating that the entity “responsible for processing personal data” is any natural person, private legal entity, or public entity that, alone or acting jointly with another, performs the processing of personal data on behalf of the owner of the personal data bank by virtue of a legal relationship that binds him to it and defines the scope of its performance.

RegDir294-2020 (approved by Res688-2020), similarly defines the “holder of the personal data bank” as the natural person, private legal person or public entity, responsible for determining the purpose and content of the personal data bank, its treatment and the security measures. As described in RegDir294-2020, personal data bank holders specifically refer to public, private, or mixed entities in the health sector that are overseen by the Ministry of Health of Peru (Ministerio de Salud del Perú (MINSA)).

Data Protection

As delineated in Law29733, the person in charge of the personal data bank, is required to protect the confidentiality and background of the owner of the personal data. This obligation continues even after the conclusion of the relationship between the owner of the personal data and the person in charge. However, the person in charge of the personal data may be relieved of the obligation to uphold the owner’s confidentiality when there is prior, informed, explicit, and unequivocal consent by the owner, or when there are justifiable reasons related to national defense, public safety, or public health.

According to Law29733, the person in charge of the personal data bank (also referred to as the person in charge of processing personal data, as per Law1353) has the following obligations:

To carry out the processing of personal data, only with prior informed, explicit, and unequivocal consent of the owner of the personal data
To not collect personal data by fraudulent, unfair, or illegal means
To collect personal data that is updated, necessary, relevant, and adequate, in relation to specific, explicit, and lawful purposes for which the data was obtained
To not use the personal data processed for purposes other than those that motivated its collection, unless there is an anonymization or dissociation procedure
To store personal data in a way that allows the exercise of the owner’s rights
To delete and replace, or where appropriate, correct the personal data subject to processing once aware of its inaccurate or incomplete nature, without prejudice to the rights of the owner in this regard
To delete personal data subject to processing when it is no longer necessary or relevant to the purpose for which it had been collected, or the deadline for its treatment has expired, unless there is an anonymization or dissociation procedure
To provide the National Authority for the Protection of Personal Data with information related to the processing of personal data that it requires, and allow access to the personal data banks that it manages, for the exercise of its functions, within the framework of an administrative procedure in case it is requested by the affected party

RegLaw1353, which regulates the application of Law1353 and strengthens the personal data protection requirements delineated in Law29733, further establishes the terms of personal data protection violations provided in Law29733. Please refer to RegLaw1353 for information on sanctions imposed on personal data violations that include, but are not limited to, failing to treat personal data without the free, express, unequivocal, prior, and informed consent of the personal data holder and conducting sensitive personal data processing in breach of established security measures.

RegDir294-2020 (as approved by Res686-2020), in turn, establishes administrative criteria for the adequate treatment of personal data related to health or personal data in health in accordance with Law26842, Law29733, and Law27806. Pursuant to RegDir294-2020, MINSA classifies information relating to the problems, situation, or health conditions of the population in the health sector into two (2) categories: Personal Health Data (DPS) or Personal Data related to Health, and Health Information (IS). DPS are those related to the health or disease situation of a person that identifies or makes the person individually identifiable, corresponding to the past, present, or predicted health and disease, physical or mental, of a person, including the degree of disability and their genetic information.

RegDir294-2020 further explains that DPS are generated in any medical or health act, or any health care received in a health facility or outside of it, including the DPS generated in health-related research. DPS also includes information related to the medical act or health information that may affect personal and family privacy or self-image, national security, and foreign relations. When subjected to the proper anonymization and dissociation procedures, DPS become IS, where it is not possible to know the identity of the owners of the original DPS. In this case, health establishments may transmit health information related to the health of its users. Additionally, information generated from the care of patients in health emergency or pandemic situations, insofar as it corresponds to DPS, must receive the same treatment that DPS receive under normal conditions per the requirements specified in RegDir294-2020. See RegDir294-2020 for more information on the treatment of DPS.

Consent for Processing Personal Data

Prior to the collection of personal data, the entity responsible for processing this data must obtain the data holder’s consent for the collection and use of personal data per the provisions of Law29733, Law1353 (which amends Law29733), and Decree003-2013.

Law29733 and Decree003-2013 provide definitions to address health related data. Per Law29733 and Law1353, sensitive data is defined as personal data constituted by biometric data that by themselves can identify the holder; data referring to racial and ethnic origin; economic income, opinions, or political, religious, philosophical or moral convictions; union affiliation; and information related to health or sexual life. Decree003-2013, in turn, provides the following definitions:

Personal data related to health – information concerning the past, present, or forecasted physical or mental health of a person, including the degree of disability and their genetic information
Sensitive data – information related to personal data referring to physical, moral, or emotional characteristics, facts, or circumstances of an individual’s emotional or family life; personal habits that correspond to the most intimate sphere; or information related to physical health or mental or other analogs that affect an individual’s privacy

Law29733 and Law1353 further explain that prior to the data collection, the holder of the personal data has the right to be informed of the following information in a detailed, simple, express, and unambiguous manner:

The purpose for which the personal data will be processed
Recipient identity
The existence of the databank in which the holder’s data will be stored, as well as the identity and address of the owner, and, if applicable, the person in charge of processing the personal data
The obligatory or optional nature of the holder’s answers to the questionnaire that is presented, especially regarding sensitive data
The transfer of personal data
The consequences of the holder providing personal data and the refusal to do so
The time during which the holder’s personal data is kept, and
The possibility of exercising the rights granted by law and the means provided for it

Decree003-2013 states that in cases involving sensitive data, consent must be granted in writing, through the personal data holder’s signature, digital signature, or any other authentication mechanism that guarantees the unequivocal will of the holder.

Law29733 and Law1353 also indicate that sensitive data is subject to special protection, and consent for the purposes of its treatment must also be made in writing. Even if the owner does not consent, the processing of sensitive data can be carried out when authorized by law, provided that it addresses important reasons of public interest.

Law29733 further states that the owner of the personal data bank, the person in charge, and others involved in any way with processing an individual’s personal data are obligated to protect the confidentiality of the individual’s background and data. This obligation continues even after the conclusion of the relationship between the personal data holder and the entity responsible for the data. However, the person in charge of the personal data may be relieved of the obligation to uphold the owner’s confidentiality when there is prior, informed, explicit, and unequivocal consent by the owner, or when there are justifiable reasons related to national defense, public safety, or public health.

In addition, per RegDir294-2020, the DPS owner’s written consent is required to process their personal data. Further, even when the owner’s consent is not obtained, sensitive data processing can be carried out when authorized by law, provided that it meets important reasons of public health interest. These reasons refer to the exceptional access to the DPS of a person(s), without their consent, when that information is necessary to protect the population. In no case does this exception extend to the entire population or groups of populations, as this would require the written and express consent of each person per Law29733.

RegDir294-2020 further explains that all DPS have an owner to whom they belong and can exercise their rights of access, rectification, cancellation, opposition, right to guardianship, objective, treatment, among others as indicated in Law29733. As long as the DPS owner gives prior and explicit written consent, the public, private, and mixed health sector entities may share the DPS owner’s information. The health sector entities must also designate an area to respond to DPS holder requests to exercise their rights regarding their information. The DPS owners must be provided the appropriate conditions to grant their consent through handwritten or digital signature, or any other authentication instrument that guarantees the owner’s unequivocal will. The DPS owner may revoke consent to the treatment of their DPS at any time, and the health professional or person who treats them must respect their will.

Refer to PER-3 for additional information on Law29733, and PER-99 and PER-101 for information on RegDir294-2020.

Title I (Articles 4-5) and Title II (Articles 25 and 27-28)

Articles 2-3, 5, 9, 13, 17-18, and 28

Supplementary Provisions ((Third Modification, Articles 2-3, and 18) and (Fourth Modification, Article 28))

Article 17 (5)

5.2

Preamble and Article 1

Introduction, 5.1, 5.3-5.5, 6.7, 6.10, and Annexes No. 02 and 05

Preamble and Article 1, Chapter I (Article 1), Supplementary Amending Provisions (Title VI, Article 132)

Article 2, 11, 14, and 18

Last content review/update: March 21, 2024

Responsible Parties

The PDPA defines the “data controller” as the person or juristic person having the power and duties to make decisions regarding the collection, use, or disclosure of the personal data.

Data Protection

Per the PDPA, the data controller must ensure that collected personal data remains accurate, up-to-date, complete, and not misleading. Personal data collection must be limited to the extent necessary in relation to the lawful purpose of the data controller. The data controller’s purpose for collecting data must meet one (1) of the purposes specified in the PDPA in order to be permitted to collect personal data, with the data subject’s explicit consent (see Section 23 of PDPA for details).

PDPA further specifies that personal data includes health and genetic data and requires the data subject’s explicit consent. Permissible personal data collection includes data collected in the interest of public health, such as protecting against cross-border dangerous contagious diseases or epidemics which may be contagious or pestilent, or ensuring standards or quality of medicines, medicinal products, or medical devices, provided there are measures to safeguard the rights and freedom of the data subject, including the confidentiality of personal data. Additionally, in the event that the data controller sends or transfers personal data to a foreign country, the destination country or international organization that receives such personal data must have an adequate data protection standard, and must be carried out in accordance with the rules for personal data protection as prescribed by the Personal Data Protection Commission (PDPC). See PDPC-Estab and THA-62 for additional information on the PDPC. Refer to the PDPA for a detailed list of permissible data collection purposes.

As set forth in the PDPA, the data controller is responsible for the following duties:

To provide appropriate security measures for preventing the unauthorized or unlawful loss, access to, use, alteration, correction, or disclosure of personal data; such measures must be reviewed when necessary, or when technology has changed in order to efficiently maintain proper security and safety, and also comply with the minimum standard specified by the PDPC
In the case of personal data being provided to other persons or legal persons other than the data controller, the data controller must take action to prevent such person(s) from using or disclosing the personal data unlawfully or without authorization
Establish an examination system for personal data erasure or destruction when the retention period ends, when the personal data is irrelevant or beyond the purpose necessary for which it has been collected, when the data subject has requested to do so, or when the data subject withdraws consent, except where the retention of such personal data is for the purpose of freedom of expression
Notify the PDPC of any personal data breach without delay and, where feasible, within 72 hours after having become aware of it, unless such breach is unlikely to result in a risk to the rights and freedoms of the persons whose data have been breached

Refer to the PDPA for additional information on data controller responsibilities. See also PDPC-Breach, G-PDPBreaches, THA-15, THA-10, and THA-17 for data controller guidelines on assessing data breach risks and applicable PDPC reporting requirements.

As described in the PDPA, with regard to personal data record management, the data controller must maintain, at least, the following records in order to enable the data subject and the PDPC to monitor in either written or electronic form the following: the collected personal data; the purpose of the collection of personal data; data controller details; personal data retention period; rights and methods for access to the personal data, including the conditions regarding the person’s right to access their personal data and the conditions to access such data; personal data use or disclosure; rejection of or objection to a request for personal data; and details of the appropriate personal data security measures.

Per the PDPA, the data protection legislation states that a data protection officer must be designated in the event the data controller/data processor is deemed a public authority per the PDPC; if the activities of the data controller/data processor in the collection, use, or disclosure of personal data, or the system itself, requires regular monitoring, due to the large quantity of personal data; or, if the core activity of the data controller/data processor is the collection, use, or disclosure of personal data for which the explicit consent of the data subject has not been obtained. See the PDPA for guidance related to data protection officers. See also THA-61 for a detailed guidance on the PDPA.

Consent for Processing Personal Data

The PDPA states that the data controller must not collect, use, or disclose personal data, unless the data subject has given consent prior to or at the time of such collection, use, or disclosure, except in the case where the data controller is permitted to do so by the provisions of the PDPA or any other laws. These cases may include the preparation of historical documents or public interest archives, research, or statistics, or preventing or suppressing a danger to a person’s life, body, or health.

The PDPA specifies that a request for consent must be made explicitly in a written statement or via electronic means unless consent cannot be done by those means. In addition, the data controller must inform the data subject of the purpose for collecting, using, or disclosing the subject’s personal data. The request for consent must be presented in an easily accessible and intelligible form and with statements using clear and plain language that is neither deceptive nor misleading to the data subject. The data controller must also ensure that the data subject’s consent is freely given.

The PDPA further explains that the data subject may withdraw consent at any time. The withdrawal of consent must be as easy as giving consent, unless there is a restriction of the withdrawal of consent by law, or the contract which gives benefits to the data subject. However, the withdrawal of consent must not affect the collection, use, or disclosure of personal data that the data subject has already legally consented to. If the withdrawal of consent will affect the data subject in any manner, the data controller must inform the data subject of the consequences of withdrawal.

In the event that the data subject is a minor who is not sui juris by marriage or has no capacity as a sui juris person under the PDPA, the request for consent from such a data subject must be made as follows:

In the event that giving consent is not an action that the minor is entitled to exercise independently, the consent of the holder of parental responsibility over the child must be obtained
Where the minor is below the age of 10 years, the consent must be obtained from the holder of parental responsibility over the child
In the event that the data subject is incompetent, the consent must be obtained from the custodian who has the power to act on behalf of the incompetent person
In the event that the data subject is quasi-incompetent, the consent must be obtained from the curator who has the power to act on behalf of the quasi-incompetent person

The above stated provisions also apply to the withdrawal of data consent of the data subject, the notice given to the data subject, the exercise of rights of the data subject, the complaint of the data subject, and any other acts under the PDPA for the data subject who is a minor, an incompetent person, or a quasi-incompetent person.

Refer to the G-PDPConsent for detailed data controller guidance on obtaining consent, and the G-PDPNotif for data controller guidelines on the conditions to be assessed when notifying a data subject of the purpose and details related to collecting their personal data. THA-16 also provides useful information on these guidelines.

Section 6, Chapter II (Sections 19-24 and 26), Chapter III (Sections 28, 35, 37, 39, 41-42)

Documentation Requirements

Last content review/update: April 24, 2024

Obtaining Consent

In all Peruvian clinical trials, a freely given informed consent must be obtained from each participant in accordance with the principles set forth in Law26842, Decree021-2017, the G-EC-CTRev, and the Declaration of Helsinki (PER-76). Decree011-2011 further states that all scientific and technological research and applications will be developed with respect for the prior, free, express, and informed consent of the person concerned, based on adequate information. Consent in such terms implies the recognition of the patient's right to be treated as a free person and capable of making their own decisions.

Per Decree021-2017 and the G-EC-CTRev, the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by an National Institute of Health (Instituto Nacional de Salud (INS))-registered institutional ethics committee (EC) (El Comité Institucional de Ética en Investigación (CIEI)) and provided to the INS with the clinical trial application. PER-83 further specifies that the sponsor or the contract research organization (CRO) must provide copies of the research protocol and ICF that are stamped and signed by the EC in its entirety as evidence that the approved version is being presented. (See the Required Elements section for details on what should be included in the form.)

As delineated in Decree021-2017, RegLaw29414, the G-EC-CTRev, and Res233-2020, investigator(s) must provide detailed research study information to the participant or legal representative/guardian. The ICF content should be presented briefly and clearly in writing, in a manner that is easy to understand, commensurate with the comprehension level of the research participants, and without coercion or unduly influencing a potential participant to enroll in the clinical trial. The participant and the legal representative/guardian should also be given adequate time to consider whether to participate. Per Decree021-2017, when drafting and presenting the ICF, special consideration must be taken with regard to the participant’s culture, traditional values, intelligence, and education.

Res233-2020, which regulates human subjects research other than clinical trials of drugs or devices, states that investigators must also submit any modifications or amendments to the initially approved research project and informed consent processes in a report to the EC in a timely manner, except in cases where these changes are necessary to prevent harm to the research participants when ECs must be informed within 24 hours. Furthermore, participants must be kept constantly informed about the changes, progress, and results of the research according to the applicable regulations.

Re-Consent

As indicated in Decree021-2017, the participant or legal representative/guardian is required to sign a revised ICF if any changes occur in the protocol or in the treatment methods or procedures.

Language Requirements

Per Decree021-2017, the ICF must be written in Spanish and in the language of the research participant.

Documenting Consent

Decree021-2017 and the G-EC-CTRev state that the participant or legal representative/guardian, and the investigator(s) must sign and date the ICF. Where the participant is illiterate or the legal representative/guardian is illiterate, a fingerprint will serve as a signature, and should be obtained in the presence of and countersigned by an impartial witness who does not belong to the research team. Before participating in the study, the participant should receive a copy of the signed and dated ICF.

Waiver of Consent

No information is available regarding waiver of consent.

Ethical Criterion 4 and Annexes 2-3

Title I (Articles 4-5) and Title II (Articles 25 and 27-28)

I, VII (7.1), and VIII (8.4)

Article 24

II (3)

Title I (Article 2), Title II (Article 11), Title III (Articles 32-34), and Annex 4

Last content review/update: March 21, 2024

Obtaining Consent

In all Thai clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in ClinImprtOrdr, ClinSampleProd, G-ResEthics, G-CT-DIPApp, and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (THA-28). Per an in-country subject matter expert, Thailand is implementing THA-28. MCEthics further states that a medical practitioner who conducts research studies and human experiments must obtain the consent of the participant and must be ready to protect the participant from harm arising from that experiment.

As per ClinImprtOrdr, ClinSampleProd, G-ResEthics, and THA-28, the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by an institutional ethics committee (EC) recognized by the Thai Food and Drug Administration (Thai FDA), and provided to the Thai FDA with the drug import license application to conduct a clinical trial. (See the Required Elements section for details on what should be included in the form.) (Note: The ICF is referred to as the Patient Information Sheet in G-CT-DIPApp.) (See also THA-18 and THA-76 for the forms included in the appendices in ClinSampleProd and ClinImprtOrdr.)

G-ResEthics and THA-28 state that the investigator(s) or the representative(s) must provide detailed research study information to the participant or legal representative/guardian. G-ResEthics and THA-28 also specify that the oral and written information concerning the trial, including the ICF, should be easy to understand and presented without coercion or unduly influencing a potential participant to enroll in the clinical trial. The participant and legal representative/guardian, should also be given adequate time to consider whether to participate. THA-11 also explains that patients who seek medical treatment have the right to receive truthful and adequate information about their illness, examination, treatment, advantages and disadvantages from the examination, and treatment from health professionals, in a language that patients can easily understand. Patients can then choose to make decisions about consenting or not consenting to the health professionals treating them, except in cases of urgent and life-threatening emergencies. THA-14 further states that researchers should take pains to explain the objectives and scope of their research to the human participants without deceiving or coercing them and they should not violate their participants’ rights as private individuals. Researchers should respect the rights and dignity of their human participants and enlist their consent prior to any research experiments involving human participants.

As per G-ResEthics and THA-28, none of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant or legal representative/guardian to waive or to appear to waive legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representatives from their liabilities for any negligence.

THA-13 provides informed consent documentation guidelines required by the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH), which is one (1) of the institutional ECs approved by the Thai FDA.

As noted in THA-34, the Central Research Ethics Committee (CREC) does not have its own informed consent documentation guidelines and directs investigators to the ICF template and checklist provided by the Forum for Ethical Review Committees in Thailand (FERCIT) (see THA-46 for document links).

Re-Consent

No information is currently available regarding re-consent requirements.

Language Requirements

As stated in ClinImprtOrdr and ClinSampleProd, the ICF content and accompanying information (Patient Information Sheet) should be presented in the participant’s language, must be submitted in Thai and translated to English, and certify that the text in other languages aligns with the Thai translation. G-CT-DIPApp also indicates that the Patient Information Sheet should be presented in Thai.

Documenting Consent

G-ResEthics and THA-28 state that the participant or legal representative/guardian, and the investigator(s) must sign and date the ICF. Where the participant is illiterate, or the legal representative/guardian is illiterate, verbal consent should be obtained in the presence of and countersigned by an impartial witness. The NatHlthAct also indicates that the participant’s consent must be obtained in writing prior to conducting the trial.

Waiver of Consent

As per G-ResEthics, the EC should establish the conditions under which an informed consent discussion and/or signing the ICF can be waived. In these cases, the investigator must explore other means to protect the participant’s confidentiality. For example, if the investigator uses information from a participant’s medical records, the investigator must also ensure that the ICF is kept in the medical record by having the participant sign the form in advance and keep it in the records, or by having the participant sign the ICF later. The EC will then consider waiving the informed consent as long as the investigator provides proof that the participant is informed about the method for collecting the data, and that the participant’s privacy is protected.

Information Sheet (p.70)

Approval documents - Informed Consent

5

Appendix 7

Appendix 11

1.27-1.28, 2.9, 3.1, 4.8, and 8.2-8.3

1. Informed consent form for clinical trials

2.2 and 3.1-3.3

11

Section 9

Preface, 1.9, and Appendix 7

1.9 and Appendix 11

Chapter 9 (Article 47)

Required Elements

Last content review/update: April 24, 2024

As delineated in Decree021-2017 and the G-EC-CTRev, the informed consent form (ICF) should include the following statements or descriptions, as applicable (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

Trial title (include version and date)
Sponsor(s), research institution, principal investigator (PI), ethics committee (EC), and the National Institute of Health (Instituto Nacional de Salud (INS)) contact information
Explicit invitation to participate in an experimental research study and the voluntary nature of participation
Trial rationale, objectives, and purpose
Trial treatments or interventions
Randomization and blinding procedures
Trial procedures and purpose
Expected duration of research participant’s involvement in the trial
The approximate number of participants in the study
Expected or unforeseeable risks and discomforts arising from the trial
Free treatment and procedures used as part of the trial design
The expected benefits that can be obtained from the study
If there are alternative procedures that could be advantageous to the participant
The commitments assumed by the participant when agreeing to participate in the study
The guarantee of receiving answers to any questions and clarification for any doubts about the procedures, risks, benefits, and other trial related matters and the treatment of the participant
In the event of trial-related injuries, contact information for the PI, the EC president, and the Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) (formerly known as the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT)))
Participant’s right to withdraw consent at any time and to stop participating in the study without creating any detriment to continue care and treatment
The participant and/or the legal representative agrees to authorize access to personal data to verify procedures and/or trial data without violating the participant’s confidentiality
The extent to which confidentiality of records identifying the participant will be maintained, and the possibility of record access by the INS and the EC
The commitment to provide up-to-date information about the investigational product (IP) or procedure, or when the participant requests this information, although this may affect the participant’s willingness to continue participating
Foreseeable circumstances and/or reasons under which the investigator(s) may remove the participant without consent
Medical treatment and compensation available to the participant in the case of trial-related injuries and proof of the sponsor’s insurance contract
Economic compensation for additional expenses (e.g., transportation, accommodation, communication, and food)
Specify when final trial results will be provided to the participant
Inform the participant of post-study access to the IP after trial completion
Provide a trial description in the INS’s Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) (PER-89) (also referred to as REPECv2)

Additionally, the G-EC-CTRev states that the participant should be provided with detailed information on the biological samples to be collected and stored. Per Decree021-2017, if biological sample storage and collection is being considered for future use, then this point should be made explicit in an additional ICF. Refer to the Consent for Specimen section for further information on participant consent requirements for use of biological samples.

See also the Vulnerable Populations section for further information.

Annex 2

Title III (Article 34) and Annex 4

Last content review/update: March 21, 2024

Based on ClinImprtOrdr, ClinSampleProd, the G-ResEthics, and the G-CT-DIPApp, the informed consent form (ICF) (also referred to as the Patient Information Sheet in G-CT-DIPApp) should include the following statements or descriptions, as applicable (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

The study purpose and objectives
The expected duration of research participant’s involvement in the trial
Experimental aspects of the study
The participant’s responsibilities in participating in the trial
Any expected risks or discomforts to the participant, and when applicable, to an embryo, fetus, or nursing infant
Disclosure of alternate procedures or treatments available to participants, including the benefits and risks
The trial treatment(s) and the probability for random assignment to each treatment
The research procedures to be followed, including all invasive procedures
The expected benefits that can be obtained from the study; if no benefit is expected, the participant should be made aware of this
Compensation and/or treatment available for the participant in the case of trial-related injury
Payment of compensation (if any) determined on a monthly basis to research participants
Various expenses (if any) for research participants
That participation is voluntary, and that the participant may refuse to participate or withdraw from the study at any time without guilt or loss of benefits to which the participant is otherwise entitled
That the Thai Food and Drug Administration (Thai FDA), research investigators, the ethics committee (EC), and regulatory agencies are permitted to directly inspect participant’s original medical records to validate the accuracy of clinical research procedures and/or other information without violating the participant's right to maintain confidentiality beyond the limits allowed by laws and regulations, and that, by signing a written ICF, the participant or legal representative/guardian is authorizing such access.
The extent to which confidentiality of records identifying the participant will be maintained
That the participant or legal representative/guardian will be notified in a timely manner if significant new findings develop during the course of the study which may affect the participant's willingness to continue
Individuals to contact for further information regarding the trial, the rights of trial participants, and whom to contact in the event of trial-related injury
Foreseeable circumstances under which the investigator(s) may remove the participant without consent
Estimated number of participants participating in research for the entire project, and the number of participants at each institution in Thailand

THA-13 provides information sheet guidelines required by the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH), which is one (1) of the institutional ethics committees approved by the Thai FDA.

As noted in THA-34, the Central Research Ethics Committee (CREC) does not have its own informed consent documentation guidelines and directs investigators to the ICF template and checklist provided by the Forum for Ethical Review Committees in Thailand (FERCIT) (see THA-46 for document links).

See the Vulnerable Populations and Consent for Specimen sections for further information. See also Appendix 11 (Part 4) in THA-18 and Appendix 7 (Part 4) in THA-76 for a checklist of items to be included in the ICF.

Information Sheet (p.70)

Approval documents - Informed Consent

Appendix 7

Appendix 11

1. Informed consent form for clinical trials

3.1.1 and 3.2

11

1.9 and Appendix 7

1.9 and Appendix 11

Participant Rights

Last content review/update: April 24, 2024

Overview

In accordance with Law26842, Decree021-2017, the G-EC-CTRev, Res233-2020, the PeruConstitution, Decree011-2011, and the Declaration of Helsinki (PER-76), Peru’s ethical standards promote respect for all human beings and safeguard the rights of research participants. Per Decree021-2017, the G-EC-CTRev, and Res233-2020, a participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process.

The Right to Participate, Abstain, or Withdraw

Decree021-2017, RegLaw29414, and the G-EC-CTRev state that the participant or the legal representative/guardian should be informed that participation is voluntary, that study withdrawal may occur at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled.

The Right to Information

As explained in Decree021-2017, RegLaw29414, and the G-EC-CTRev, a potential research participant or legal representative/guardian has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation for participation or injury/treatment, and any significant new information regarding the research study.

The Right to Privacy and Confidentiality

Pursuant to Decree021-2017 and the G-EC-CTRev, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right. The ICF must also incorporate the following items related to privacy:

Data the participant will have access to and what information will be collected
How collected data will be used, stored, and protected, and who will have access
That representatives of the sponsor, ethics committee (EC), and the National Institute of Health (Instituto Nacional de Salud (INS)) will have access to the data
How biological data and samples are handled if consent is withdrawn
That participants’ data will be de-identified in the case of publications and presentations of the clinical trial results

The Right of Inquiry/Appeal

Per Decree021-2017 and the G-EC-CTRev, the research participant or legal representative/guardian should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries and/or to appeal against a violation of the participant's rights.

The ICF must guarantee that the participant will receive answers to any questions and clarification to any doubts about the procedures, risks, benefits, and other matters related to the clinical trial and the treatment of the participant. There must also be a commitment to provide up-to-date information about the product or procedure under investigation when the participant requests it.

The Right to Safety and Welfare

Decree021-2017, the G-EC-CTRev, and Decree011-2011 indicate that the research participant’s dignity, safety, and welfare must be guaranteed while ensuring the quality of the research process in developing new products. The G-EC-CTRev further states that the interests of science cannot take precedence over the interests of the research participants.

VII, Ethical Criterion 4, Ethical Criterion 5, and Annex 2

Title I (Articles 4 and 5) and Title II (Articles 25, 27, and 28)

Chapter 1 (Articles 1 and 2) and Chapter 2 (Article 7)

I and VIII (8.4)

Articles 18 and 24

Preamble, Article 2, II (1-3), and V (1 and 6)

Title I (Article 4), Title II (Article 9), Title III (Article 34), Title IV (Article 40), and Annex 4

Last content review/update: March 21, 2024

Overview

In accordance with G-ResEthics and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28), Thailand’s ethical standards promote respect for all human beings and safeguard the rights of research participants. The Declaration of Rights and Code of Conduct for Patients (THA-11) also states that every patient has the fundamental right to receive professional medical care and health care from health professionals without discrimination as provided for in the Constitution of the Kingdom of Thailand (B.E. 2560). Per an in-country subject matter expert, Thailand is implementing THA-28. ClinImprtOrdr, ClinSampleProd, G-ResEthics, THA-28, the NatHlthAct, and G-CT-DIPApp, state that a participant’s rights must also be clearly addressed in the informed consent form (ICF) (also referred to as the Patient Information Sheet) and during the informed consent process.

The Right to Participate, Abstain, or Withdraw

As set forth in ClinImprtOrdr, ClinSampleProd, G-ResEthics, G-CT-DIPApp, and THA-28, the participant or legal representative/guardian should be informed that participation is voluntary, that the participant may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled. NatHlthAct also states that the participant may withdraw consent at any time. THA-11 similarly states that the patient has the right to be fully informed in order to make a decision to participate or withdraw from being a participant in a health practitioner’s research.

The Right to Information

As delineated in ClinImprtOrdr, ClinSampleProd, G-ResEthics, the NatHlthAct, G-CT-DIPApp, and THA-28, a potential research participant or legal representative/guardian has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation for participation or injury/treatment, and any significant new information regarding the research study. THA-11 states that patients who seek medical treatment have the right to receive truthful and adequate information about their illness, examination, treatment, advantages and disadvantages from the examination, and treatment from health professionals, in a language that patients can easily understand. Patients can then choose to make decisions about consenting or not consenting to the health professionals treating them, except in cases of urgent and life-threatening emergency.

The Right to Privacy and Confidentiality

As per ClinImprtOrdr, ClinSampleProd, G-ResEthics, G-CT-DIPApp, and THA-28, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right. In addition, per G-ResEthics, which incorporates the principles of the Declaration of Helsinki (THA-45), every precaution should be taken to respect the privacy of the participant, the confidentiality of the participant’s information, and to minimize the impacts of the study on the participant. THA-11 further states that unless the patient’s permission or approved legal authorization is obtained, healthcare personnel cannot disclose the patient’s information.

The Right of Inquiry/Appeal

ClinImprtOrdr, ClinSampleProd, G-ResEthics, G-CT-DIPApp, and THA-28 state that the research participant or the legal representative/guardian should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries. THA-11 similarly indicates that every patient has the right to know the name, surname, and profession of the healthcare personnel in charge.

The Right to Safety and Welfare

G-ResEthics states that a research participant’s right to safety and the protection of the participant’s health and welfare must take precedence over the interests of science and society. THA-14 explains that researchers should take full responsibility for the impact and consequences of their research regarding themselves, their research participants, and society at large.

(See the Required Elements and Vulnerable Populations sections for additional information regarding requirements for participant rights.)

4

1.28, 4.8, and 8.2

2.2, 3.1-3.3, and 4.1

11

Section 9

1.9

Emergencies

Last content review/update: April 24, 2024

No information is currently available.

Last content review/update: March 21, 2024

Per the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28), research participants involved in clinical research under emergency circumstances are viewed as vulnerable and should be provided additional protections to ensure their safety and well-being. Per an in-country subject matter expert, Thailand is implementing THA-28. In addition, per the Declaration of Rights and Code of Conduct for Patients (THA-11), patients who are in a life-threatening condition are entitled to immediate, urgent assistance from a healthcare practitioner as required, regardless of whether the patient requests assistance.

THA-28 explains that in an emergency, if the signed informed consent form (ICF) cannot be obtained from the research participant, the consent of the legal representative/guardian should be obtained. If prior consent cannot be obtained from the legal representative/guardian, the participant’s enrollment should follow measures specified in the protocol, and/or elsewhere, to ensure compliance with ethics committee (EC) and other applicable regulatory requirements. Documented EC approval to protect the participant’s rights, safety, and well-being must also be obtained. The participant or the legal representative/guardian should be informed about the trial as soon as possible and provide consent. Consent should also continue to be obtained throughout the trial as appropriate per THA-28. However, THA-11 further notes that except in an emergency, every patient has the right to obtain sufficient information regarding their illness from healthcare personnel prior to deciding to allow any treatment.

1.61, 3.17, and 4.8.15

Vulnerable Populations

Last content review/update: April 24, 2024

Overview

As per Decree021-2017, in all Peruvian clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. Additionally, the G-EC-CTRev specifies that the ethics committee (EC) should identify the vulnerabilities of the research participants to determine the additional protections required and to protect their welfare and rights.

Decree021-2017 defines vulnerable populations as those who are relatively (or absolutely) incapable of protecting their own interests due to a lack of autonomy, intelligence, education, resources, strength, or other necessary attributes. This may include those in subordinate groups, indigenous or native peoples, and those who cannot give their consent. In addition, per Decree011-2011, in the case of individuals who do not have the capacity to exercise their autonomy, measures will be taken to safeguard their rights, always ensuring what is most favorable to them. The protection of human life considers the protection of health, as well as taking into account vulnerability and personal integrity. Decree011-2011 further explains that the cultural and plural diversities of Peru cannot represent a justification for transgressing legitimate limits established by the recognition of the principle of respect for human dignity.

See the Children/Minors; Pregnant Women, Fetuses & Neonates; and Mentally Impaired sections for additional information about these vulnerable populations. Information on the other vulnerable populations specified in Decree021-2017 is provided below.

Indigenous Peoples

As explained in Decree021-2017, clinical trials involving participants from indigenous communities may only be conducted under the following conditions:

When the expected benefit is reasonably assured; that is, when the product or knowledge generated by research is available or applied for the benefit of the community
The principal investigator (PI) has the approval to conduct the trial from the regional health authority and other authorities in the community, in addition to obtaining informed consent from trial participants
Sponsors and investigators develop culturally appropriate ways through working with anthropologists, sociologists, and translators to communicate the necessary information, and to meet the standards required in the informed consent process. In addition, the research protocol must describe and justify the methods the investigators plan to use to communicate information to research participants
Investigators agree to discontinue using individual participants when the community does not have the capacity to understand the implications of the participants’ involvement in the trial, despite the use of a translator or interpreter
In the case of including biological storage samples, it must have the authorization of the corresponding regional and local government, and of the respective community authorities, who must consider the interest of the community involved

The G-EC-CTRev further notes that the EC should ensure it has adopted all the appropriate measures when running a clinical trial in a community to minimize the potentially negative effects on the group and to ensure the community’s active involvement in the trial. The G-EC-CTRev also references Decree021-2017’s provision pertaining to indigenous communities, which requires approval by the community’s authorities to conduct the study prior to obtaining individual informed consent. However, approval by the community authorities may not replace the consent of each individual research participant within the group.

Persons in Dependent Groups

Per Decree021-2017, clinical trials involving participants in subordinate or dependent relationships must meet the following requirements:

One (1) or more of the EC’s members must represent the population under study or work with someone who has expertise in addressing social, cultural, and other issues related to the group in question
Refusal or withdrawal of consent during the trial should not affect a participant’s performance review or result in any negative consequences to the participant

These relationships include participants who are in junior or subordinate positions in hierarchically structured groups, such as students and teachers, employees and their supervisors, and soldiers and their superiors in military settings.

Persons with Physical Disabilities

Per Decree021-2017 and Decree021-2017-Correct, in clinical trials involving participants with physical disabilities that prevent them from signing the informed consent form (ICF), but with the mental capacity to provide their consent, their legal representative(s) may grant their written consent by printing their fingerprint. This consent must be provided in the presence of at least one (1) witness designated by the participant and does not belong to the research team, and who in turn will sign the ICF. If the participant is unable to sign or provide a fingerprint, another means may be used that the participant approves. In this case, the legal representative(s) are required to sign the ICF with a witness present who is not a member of the research team. The participant and/or the legal representative(s) may withdraw consent at any time without negative consequences as long as the withdrawal does not jeopardize the participant’s health.

Additionally, in the case of participants who, due to disabilities, are unable to give their informed consent and have not given consent prior to the onset of their disability, the following provisions must be met:

The informed consent must comply with the requirements delineated in the Required Elements section
The protocol must be approved by an EC that has experts in the disease under study, or has consulted on the clinical, ethical, and psycho-social aspects in the area of the disease and the group of patients affected

The G-EC-CTRev also notes that, per Law1384 which amends Law295, persons with disabilities have an equal capacity to exercise their rights in all aspects of life, including the right to choose to be a participant in a research study with the support of a legal representative(s), if applicable. In addition, Law1384 states that any person with a disability that requires reasonable adjustments or support to exercise their legal rights may request or designate a legal representative(s) of their choosing for assistance. Persons with disabilities who cannot communicate their own wishes will receive support and safeguards from judicially designated entities.

Ethical Criterion 4, Ethical Criterion 5, and Ethical Criterion 6

Articles 1-2

Title II (Article 3) and Title V (Articles 42-44 and 46-47)

II (1-3)

Title I (Article 2) and Title III (Articles 19, 24-25, 33, and 38)

Last content review/update: March 21, 2024

Overview

As per G-ResEthics and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28), in all Thai clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. Per an in-country subject matter expert, Thailand is implementing THA-28.

G-ResEthics characterizes vulnerable populations as those who are dependent on others and are unable to express their opinion freely or make their own decisions. THA-28 adds that, whether reasonable or not, the participant may also consent to participate out of fear that they will be penalized for not participating. This may apply, for example, to members of a hierarchical organization such as medical, pharmacy, dental, or nursing students and lower-level hospital personnel and staff rooms. THA-28 also notes that participants in this study population may be persuaded to enter a trial with the hope of obtaining benefits from their participation in the research. Per G-ResEthics, these participants may include hospitalized patients, prisoners, children, the mentally impaired, critically ill and psychotic patients, pregnant women, and the disadvantaged. Per THA-28, other vulnerable participants may include drug company employees, soldiers, prisoners, patients with incurable diseases, emergency patients, unemployed or poor people, members of minority groups, the homeless, immigrants, and young people who are unable to give consent on their own.

The G-ResEthics specifies that trials involving vulnerable persons must meet the following requirements:

Irrefutable rationale for conducting research clearly explained in the protocol
Precautions against possible physical and mental harms exercised
Appropriate research procedures used
Ensure that, as applicable, the participant’s parents or legal representative/guardian are fully informed about the study
Proof that the participants are voluntarily participating in the study
Ensure that the possible risks should not be greater than minimal when a study will not have a direct health benefit to the vulnerable group, unless the ethics committee permits a greater than minimal risk study to be conducted

See the Children/Minors; Pregnant Women, Fetuses & Neonates; and Mentally Impaired sections for additional information about these vulnerable populations.

1.61

2.2.2 and 3.4

Children/Minors

Last content review/update: April 24, 2024

Pursuant to Law27337, Law295, Law1384, and the G-EC-CTRev, the age of majority is 18 years of age. Per Law295 and the G-EC-CTRev, children under 16 are considered to be absolutely incapable of providing consent, except for those acts determined by law. Individuals who are over 16 and under 18 are considered to be relatively incapable of providing consent. However, individuals older than 16, who are married, or have obtained an official title authorizing them to practice a profession or trade, are exempt from this regulation. Per Law295 and Law1384, females over 14 who are married are also exempt from this regulation. If a marriage is terminated, individuals who acquire this capacity by marriage do not lose this right. Law1384 further clarifies that individuals over 14 and under 18 who marry, or who become parents are considered fully capable of providing consent.

Per Decree021-2017, for studies involving minors, an ethics committee (EC) that has a specialist in pediatrics, or has obtained advice on the clinical, ethical, and psycho-social aspects of the trial from a pediatric expert, if applicable, must approve the protocol.

Assent Requirements

Per Decree021-2017 and the G-EC-CTRev, the assent of a pediatric participant from the age of eight (8) and under 18 years of age must be obtained to participate in an investigation.

In addition to a minor providing assent, Decree021-2017 and the G-EC-CTRev state that the consent of both parents or the minor’s legal guardian is required. Per Decree021-2017, the consent of the legal guardian may only be dismissed in the case of death, loss of rights according to Decree requirements, or proven impossibility to obtain consent has been documented appropriately. In the event that one (1) parent is a minor, the consent of the direct ascendant relative is also required unless the parent is a minor of 16 years of age or more, the participant has gotten married, or has obtained an official professional or trade title as earlier noted per Law295.

Decree021-2017 further explains that all pediatric participants should be fully informed about the trial and its risks and benefits in language and terms that they are easily able to understand. The investigator(s) must also accept the withdrawal of informed consent at the request of the child’s legal guardian at any time, provided that the child’s health will not be jeopardized. A minor who is a teenager must also be excluded from a trial when a conflict of views exists between the legal guardian and the teenager. A minor who reaches the age of majority during a trial must provide consent before continuing to participate in the study.

Ethical Criterion 4

Article 1

Preliminary Title (Article 1)

Title V (Articles 42-46)

Title I (Article 2) and Title III (Articles 18, 33, and 36)

Last content review/update: March 21, 2024

According to the ThaiCode, a minor is someone under 20 years of age or unmarried. The Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH) guidelines (THA-13) specifies that the age suitable to give consent is 18 years or older. The Declaration of Rights and Code of Conduct for Patients (THA-11) also indicates that a child is someone under 18 years of age.

As set forth in G-ResEthics, when the research participant is a minor, informed consent should be obtained from the parents, guardians, or legal representatives. Additionally, precautions against possible physical and mental harms should be exercised. Furthermore, the rights of the minors should be respected for their voluntary decision to participate in a clinical study. THA-11 similarly indicates that parents or legal guardians may exercise their rights on behalf of a child patient who is not over 18 years of age.

The International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28) states that when a clinical trial includes minors, the minor should be informed about the trial to the extent compatible with the minor’s understanding and, if capable, the minor should sign and personally date the written informed consent. Per an in-country subject matter expert, Thailand is implementing THA-28.

Assent Requirements

THA-13 specifies that assent is required for minors seven (7) through 18 years of age. Different assent forms should be created for the following age groups: seven (7) to 13 and over 13 until 18.

Additional Suggestion of the Committee (2004) (p. 75) and Additional Resolution of the Committee (2006) (p.77)

4.8.12

2.2.2 and 3.4

Part II (Sections 19 and 20)

Pregnant Women, Fetuses & Neonates

Last content review/update: April 24, 2024

As per Decree021-2017, studies involving women of childbearing age or who are pregnant require additional safeguards to ensure that the research assesses the risks and benefits as well as any potential impact on fertility, pregnancy, the embryo or fetus, labor, lactation, and the newborn.

Clinical trials may only be conducted under the following conditions:

The informed consent of the woman and her spouse or partner is obtained, and they are given information about any potential risks to the embryo, fetus, or newborn prior to the trial
The spouse’s or partner’s consent may only be dismissed in the case of death; their inability to provide reliable consent; loss of rights; or when there is imminent risk to the health or life of the woman or the embryo, fetus, or newborn
Informed consent may be withdrawn by the woman or spouse’s or partner’s request at any time, without detriment to them, provided the woman or fetus is not endangered
The research must be preceded by trials in non-pregnant women to demonstrate their safety, except for specific tests that require pregnant participants
The research must be aimed at improving the health of pregnant women and represent only a minimal risk to the embryo or fetus and the participant
During the study, investigators will not have the authority to decide on the timing, method, or procedure used to terminate the pregnancy, or to participate in decisions about the viability of the fetus
Informed consent for pregnant teenagers complies with the requirements stated in the Children/Minors section

Clinical trials may only be carried out in women in labor, postpartum, or breastfeeding when the following conditions are met:

Consent must be obtained before labor starts
Research will be authorized in postpartum women and breastfeeding only when there is minimal risk to the infant
Informed consent may be withdrawn at the request of the participant, spouse, or partner at any time, without detriment to them, provided they do not affect or endanger the mother or the fetus or infant
The clinical trial has the potential to generate direct benefits greater than the risks to the nursing woman or child after birth

See Title III (Article 23) of Decree021-2017, for additional details on embryos, fetuses, and newborns.

Research Involving Men and Women with Reproductive Capacity

Clinical trials involving men and women with reproductive capacity are only permitted under the following conditions:

For women, the principal investigator (PI) must conduct a pregnancy test to rule out any pregnancies, and to secure commitment from the women to use effective contraceptive methods. The sponsor will provide free access and a list of contraceptive methods to the participant(s) to be selected by the participant(s) and consistent with the trial
In the event of pregnancy during the study, the protocol should establish the exclusion of the mother; the application of procedures to monitor and control the pregnancy as well as monitoring and control of the newborn until at least six (6) months of age to identify any effects related to the investigational product
For men, the PI must secure a commitment from the men to prevent conception, and to use effective contraceptive methods to be provided free of charge to the participant(s) by the PI/sponsor, as specified in the protocol and the informed consent form

Title III (Articles 20-23) and Annex 4

Last content review/update: March 21, 2024

As per G-ResEthics, any Thai clinical studies involving pregnant women and fetuses require additional safeguards to ensure that the research conforms to appropriate ethical standards and upholds societal values. Adequate information on the safety and impacts to the fetus should also be made available.

In addition, the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28) indicates that the informed consent form should include a statement on the reasonably foreseeable risks or inconveniences to the participant, and when applicable, to an embryo, fetus, or nursing infant. Per an in-country subject matter expert, Thailand is implementing THA-28.

4.8.10

2.2 and 3.4

Prisoners

Last content review/update: April 24, 2024

No information is currently available.

Last content review/update: March 21, 2024

According to G-ResEthics, prisoners are considered vulnerable because incarceration could affect their ability to make a voluntary decision regarding participation in research. A research study involving prisoners should ensure that these prospective participants are informed and are given the opportunity to make their own decisions without any interference from a higher authority.

2.2, 3.2, and 3.4

Mentally Impaired

Last content review/update: April 24, 2024

Law30947 establishes a legal framework that guarantees access to services, promotion, prevention, treatment and rehabilitation in mental health as conditions for the full exercise of the right to health and well-being of the person, the family, and the community. The law states that mental health care takes into account the model of community care as well as respect for human rights and the dignity of the individual, without discrimination and using the intercultural approach, which eliminates the stigmatization of people with mental health problems. Some of the principles addressed in Law30947 specifically applicable to ensuring consent in this vulnerable population include:

Confidentiality – Mental health care guarantees the confidentiality of information obtained in the clinical context. The disclosure, examination, or release of medical records without the express consent of the individuals involved, or if applicable, the consent of their legal representative(s), is prohibited
Dignity – Care and treatment of an individual with mental health issues is based on protecting and promoting the dignity of an individual through the recognition of fundamental rights
Human rights – The therapeutic, prophylactic, and promotional strategies, actions, and interventions in mental health matters must comply with the Convention on the Rights of Persons with Disabilities (CRPD) (PER-54) and other international and regional human rights instruments to which Peru is a party

Law30947 defines a representative as a person who, according to law, gives consent for the treatment of the mental health problems of children and adolescents. In the treatment of psychiatric disorders, mental health services also consider the special needs of the population in vulnerable situations and prioritizes mental health care in vulnerable populations including early childhood, adolescence, women, and older adults.

Per Law30947, some, but not all, of the rights of users of mental health services related to consent are listed below:

To receive complete, timely, and ongoing information about their mental health status, in understandable terms, including diagnosis, prognosis, and treatment alternatives; as well as the risks, contraindications, precautions, and warnings of the interventions, treatments, and medications that are prescribed and administered
To be informed of their right to refuse to receive or to continue treatment, and to explain the consequences of that refusal
To authorize or not the presence of people who are not directly related to medical care, at the time of the evaluations
To allow their consent to be in writing when they are the subject of investigation for the application of medications or treatments
To choose not to receive a contraception method without prior informed consent, and to be obtained by the individual when not in a crisis due to the diagnosed mental health problem
To not be discriminated against or be stigmatized for having or for suffering from, permanently or temporarily, a mental health problem
To be treated with respect in regard to their dignity, autonomy, and needs, in accordance with the provisions of the CRPD

In addition, Law295 further states that individuals who for any reason are deprived of discernment, are considered to be absolutely incapable of giving consent. Individuals who suffer from mental deterioration that prevents them from expressing their free will are considered to be relatively incapable of giving consent.

The G-EC-CTRev specifies that persons who are temporarily mentally incapacitated may participate in a research study if their designated legal representative/guardian decides on their behalf to allow them to participate per the requirements specified in Law1384, which amends Law295. The legal representative/guardian should be over 18 years of age. When no support has been designated and there is no representation for a mentally incapacitated person, the decision regarding participation in a clinical trial will be made by the person’s legal representative/guardian in accordance with the consanguinity or affinity ties delineated in RegLaw29414. See Law1384 and RegLaw29414 for requirements related to the roles and responsibilities of legal representative/guardian.

Decree021-2017, in turn, indicates that the following conditions must be met for clinical trials involving participants who are mentally incapable of giving consent:

Informed consent must be obtained from the legal representative/guardian who have been informed of the possible risks, discomforts, and benefits of the trial
Informed consent may be obtained after the participant has been fully informed about the trial in easily understandable language
Consent may be withdrawn at any time without harm to the participant or legal representative/guardian

As delineated in the G-EC-CTRev, persons in a comatose state may be involved in a clinical study as long as the appropriate legal representative/guardian are in place that comply with Law1384, which amends Law295. According to Law1384, any legal representative/guardian designated prior to a person becoming comatose will be upheld. However, for those persons who have not designated a legal representative/guardian, a judge shall designate the necessary supports and safeguards. This measure will only be taken after efforts have been made to obtain the person’s consent and when the designation of legal representative/guardian is necessary for the exercise and protection of the participant's rights.

Ethical Criterion 4

Articles 2-3

Articles 1, 3-4, 6, 9, and 32

Title V (Articles 43-47)

Article 5

Title IV (Article 37)

Last content review/update: March 21, 2024

Per G-ResEthics, informed consent should be obtained from the legal representatives or guardians of participants for studies involving psychiatric or mentally incapacitated patients. The Declaration of Rights and Code of Conduct for Patients (THA-11) also states that parents or legal representatives may exercise their rights on behalf of a physically or mentally handicapped child patient who cannot exercise their rights on their own.

As further explained in MentalHlthAct, any research to be conducted with patients who are mentally impaired have the right to:

Receive treatment according to medical standards that protect human dignity
Have information about their illness and treatment kept confidential other than what is required to be disclosed by law
Sign an ethics committee (EC) approved consent form prior to participation
Receive equal access to state health insurance and social security systems

In addition, MentalHlthAct prohibits disclosure of health information of mentally impaired participants in a manner that may damage the individual, except in the event that the patient or others may be in danger, for public safety, or specific laws require this information to be disclosed.

MentalHlthAct also states that any research involving patients who are mentally impaired can only be performed after obtaining their consent as well as EC approval and approval from other relevant authorities to conduct the study. The patient’s approval may be revoked at any time. Treatment may only be administered once the patient has been informed as to why the treatment is necessary and provided with the details and benefits prior to giving consent. In the case of a patient under 18 years old, or one who lacks the ability to make decisions, the patient’s parent or legal guardian should provide consent. If the patient is to be admitted to a public hospital or treatment facility, signed consent is necessary. Research is permitted in the case of patients with mental impairments who are either facing dangerous conditions or compulsory treatment is required.

3.4.5

Sections 3, 17, and 20-22

Definition of Investigational Product

Last content review/update: April 24, 2024

As delineated in Decree021-2017 and the G-SafeRpt, an investigational product (IP) is defined as a pharmaceutical form of an active substance or placebo, being tested or used as an active comparator in a clinical trial. This includes a product with a marketing authorization when it is used or assembled (formulated or packaged) in a different way from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use.

Decree021-2017 also defines a placebo as a product with a pharmaceutical form, with no active ingredient, and therefore devoid of specific pharmacological action, which may be used as a control in the clinical trial or for maintaining blinding.

V

Title I (Article 2)

Last content review/update: March 21, 2024

In accordance with G-ResEthics and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28), an investigational product is defined as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial. This includes a product with a marketing authorization when it is used or assembled (formulated or packaged) in a different way from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use. Per an in-country subject matter expert, Thailand is implementing THA-28.

G-ResEthics states that an investigational drug used in a clinical trial falls into one (1) of four (4) categories:

New drugs
Unregistered drugs in Thailand
Drugs registered by the national drug authority, but being studied in new doses or indications not previously approved
Locally produced drugs that require efficacy testing

1.33

7.1 and Annex 5

Manufacturing & Import

Last content review/update: April 24, 2024

Manufacturing

According to Decree021-2017, Decree016-2011, the INS-CTManual, and Res252-2022 (which amends the INS-CTManual), the sponsor or the contract research organization (CRO) must obtain approval from the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)) to manufacture investigational products (IPs) exclusively for research purposes in Peru. Decree021-2017 states that the manufacture of IPs in the country will be subject to Good Manufacturing Practices (GMPs) and other regulations issued by the Ministry of Health of Peru (Ministerio de Salud del Perú (MINSA)). Decree016-2011 further specifies that the national manufacture of pharmaceutical products for research purposes involving human beings must be carried out in pharmaceutical establishments that have a sanitary authorization and a GMP certificate, as appropriate. Refer to Decree016-2011 for detailed ANM pharmaceutical manufacturing requirements. (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)) (PER-109)).

Import

As delineated in Decree021-2017, the INS-CTManual, and Res252-2022, to obtain clinical trial authorization, the National Institute of Health (Instituto Nacional de Salud (INS))’s Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) (formerly known as the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT))) requires the sponsor or the CRO to provide a list of products and supplies necessary for the development of the clinical trial using form FOR-OGITT-033 (PER-42). This form requires the sponsor or the CRO to provide the following data:

Name of product
Active ingredient(s)
Route of administration
Pharmaceutical form and concentration
Manufacturer name
Country of origin
Quantity
Lot number or coding system

Decree021-2017 and Decree016-2011 also specifies that the ANM will authorize the import of IPs exclusively for research involving humans when the applicant can provide information to support the product’s safety and quality according to the stage and type of research being conducted. Documentation requirements for ANM’s approval are as follows:

Application for authorization to import the product(s) under investigation and complementary products
Copy of INS clinical trial approval
List of INS-approved research products, complementary products, and supplies to be used in the trial (see Form FOR-OGITT-033 (PER-42))
Proof of payment for processing fee

Decree021-2017 specifies that the ANM will grant this authorization within three (3) business days of filing the application.

See Scope of Assessment section for additional information on the ANM’s role in the clinical trial application approval process, and PER-6 for a flowchart delineating the clinical trial authorization process.

In addition, per Decree021-2017, the INS-CTManual, and Res252-2022, the sponsor or the CRO must apply to the INS’s DIIS using PER-42 to modify or expand the list of supplies to be imported. Per the INS-CTManual, the INS approval process will be completed within a maximum of 10 business days.

According to Decree021-2017, the following documents must be submitted:

Request for expansion or modification of the list of supplies
Report justifying the reasons for the expansion or modification of the list of supplies
Additional or modified detailed list of supplies necessary for the trial’s execution

The INS-CTManual further explains that in addition to submitting PER-42 and a report justifying the reasons for the amended supply list request, the following should be provided:

To modify by the batch number: Certificate of analysis and IP labeling
To modify by the manufacturer or country: Certificate of Good Manufacturing Practices, Certificate of analysis, and IP labeling

See PER-42 for the form and the INS-CTManual for detailed instructions on completing this form.

Please note: Peru is party to the Nagoya Protocol on Access and Benefit-sharing (PER-11), which may have implications for studies of IPs developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see PER-57.

Chapter VII (7.6), Chapter IX, and Annex 4 (Flowcharts No. 04 and 08)

Requirements for Initiating the Procedure (10 and 13), 4.1-4.4, and Annexes 1 and 9

Title II (Chapters I and V)

Title I (Article 8), Title V (Article 75), Title VI (Articles 90 and 94), and Annex 5

Last content review/update: March 21, 2024

Manufacturing

According to the DrugAct, ClinSampleProd, and ClinImprtOrdr, the Thai Food and Drug Administration (Thai FDA) is responsible for authorizing the manufacture of investigational products (IPs) in Thailand. The Thai FDA will approve the manufacture of an IP after the clinical trial application has been approved.

As explained in ClinSampleProd, the Thai FDA’s approval of a request to manufacture drug samples for investigational purposes is obtained using the P.Y.8 form (ClinSampleProd (Appendix 1) or THA-76 (Appendix 1)).

ClinSampleProd specifies that the following information must be included with the P.Y.8 form (Appendix 1):

Detailed list of manufactured drugs
Appearance and color of medicine
Number or quantity to be produced
Quantity of drug ingredients (must be reported in metric units or in a percentage)
Packaging size (packaging details)
Specifying if drug samples are for human research studies or cases other than human research studies
Drug label (two (2) copies)
Medicine package document (two (2) copies)
Other documents in the case of producing drug samples for human research studies

See also the Appendix 6 (Evidence of Drug Quality Information) in ClinSampleProd and (THA-76 (Appendix 6)) for additional requirements included on this form.

ClinSampleProd and ClinImprtOrdr, also state that the IP must be manufactured in accordance with good manufacturing practice (GMP) guidelines.

In addition, per ClinSampleProd, following the Thai FDA’s approval to manufacture IP samples, the applicant must also obtain approval prior to implementing changes in the following categories:

Changes that must be notified
Changes that require a change request to be submitted before proceeding, and
Changes that require a new production permit request to be submitted

ClinSampleProd indicates that when the change complies with one (1) of the listed categories, the applicant should:

Prepare documents and evidence according to the document self-check form for requesting changes using the Appendix 13 form or (THA-76 (Appendix 13))
Submit a request to amend the details regarding permission using the Appendix 14 form or (THA-76 (Appendix 14)) (1 set)

Per ClinSampleProd, along with the Appendix 14 form, the applicant should attach relevant documents showing the revised section(s) and one (1) set of power of attorney documentation for each paper submission. ClinSampleProd notes that one (1) request can only change one (1) main issue. For example, in the case of requesting to extend the validity of medicines, this is a change in quality and results in a new expiration date label) to be submitted in one (1) request. Additionally, for amendment requests that refer to information already submitted via the FDA’s Skynet E-Submission System (THA-54), the applicant must submit documents according to the system's procedures.

For changes that require the Thai FDA’s Medicines Regulation Division to be notified, ClinSampleProd states that the applicant should submit a letter of explanation, refer to the sample drug production license for human research studies that has been received, and attach related documents showing the revised sections or other information that needs to be notified as detailed in the Appendix 15 form or (THA-76 (Appendix 15)).

Import

As delineated in ClinImprtOrdr, the Thai FDA is also responsible for authorizing the import of IPs. The Thai FDA’s approval of a drug import license application for clinical research purposes serves as the import license using the N.Y.M.1 form (ClinImprtOrdr (Appendix 2) and THA-18 (Appendix 2)). Per DrugImprtRules-1989 and DrugImprtRules-2009, all requests approved by the Thai FDA to order or import drugs into the country for research purposes are exempt from registration.

According to ClinImprtOrdr and THA-18, the following documents are also required to be submitted to the Thai FDA:

Import license application/N.Y.M.1 (ClinImprtOrdr (Appendix 2) and THA-18 (Appendix 2))
Summary of research project (Thai)
Ethics committee (EC) approval letter
Patient Information Sheet (in Thai)
Complete research project details (in Thai or English)
Drug labels for every package size (in Thai or English)
Drug documentation (for drug formulas that have already been registered)
Investigator’s brochure (IB) (for drugs not yet registered)
Pharmaceutical quality control and production documents
Drug name(s) (including dosage form, quantity, and details of every packaging size)

ClinImprtOrdr also states that the quantity of the IP must be calculated based on the number of study participants of each institute for the whole study duration in accordance with the information in the study protocol. The amount of the IP cannot exceed 20% to cover drug damage. Please refer to ClinImprtOrdr for more detailed IP supply requirements.

In addition, per G-CT-DIPApp, after the import license is granted, the applicant must inform or request permission from the Thai FDA prior to initiating the following:

Changes to clinical trial drug supplies
Changes to an approved protocol (protocol amendment) or changes related to or affecting participant safety
In cases where the sponsor is required to immediately make one (1) or more amendments because the clinical trial or the use of IP in the trial endangers the health of a clinical trial participant or other person, the applicant may immediately make the amendment without prior review by the Thai FDA. A corresponding notification clearly identifying the change and the rationale for immediate implementation of the change must be filed within 15 working days after the amendment implementation date. A corresponding notification letter referring to the related approved import license (see ClinImprtOrdr (Appendix 2) and THA-18 (Appendix 2) for N.Y.M.1 form), along with supplemental documents as stated in Appendix 12, are also required. (Note: The Additional Amendment/Clarification Request Form referenced in G-CT-DIPApp as Appendix 12 is only available in ClinImprtOrdr and THA-18 (Appendix 12))

Furthermore, per G-CT-DIPApp, after the import license is granted, the applicant must also notify the Thai FDA in the following cases:

Changes to the protocol that do not affect the safety of the trial participants
When the clinical trial has been discontinued in its entirety or at any clinical trial site for reasons not related to the safety of clinical trial participants
IB changes
Chemistry and manufacturing or quality changes that do not affect drug quality or safety
Premature discontinuation of a trial (See the Risk & Quality Management section for detailed notification requirements)

Per THA-19, a request for an expedited license to order or import IPs may also be submitted to the Thai FDA for the following:

Clinical research purposes
To produce sample IPs for human research
To expand the scope of drug results for human research to include a new research project
To address a public health emergency
To address an urgent clinical research need, in the event a facility runs out of an IP (an EC waiver may be required)

See the Regulatory Fees section for information on IP import fees. See also the Submission Process section for instructions on submitting a drug import waiver request to the Thai FDA.

The DrugAct states that a license will remain valid until December 31st of the year of issue. The license holder who would like to renew the license must file an application for renewal prior to the license expiration date. Once the renewal application has been filed, the license holder may continue to conduct business unless the renewal request is denied. A license holder whose license has expired for not more than one (1) month may file an exemption indicating the reason for obtaining a license extension. However, an application renewal request submitted after one (1) month from the date of license expiration is not permitted. In the event that the Thai FDA does not issue or grant a license renewal request, the applicant may appeal in writing to the Minister within 30 days from the date of receiving the notice rejecting the request. The applicant may obtain a temporary license to operate the business until a final decision is issued by the Minister.

Appendices 1-3, 6-7, and 12-15

Appendices 2-4, 7-8, 11-12, and 17-19

14.2 and 16.2

Chapter I (10), Chapter II (12), Chapter III (25 and 27), and Chapter V (46)

Preface, 1.1-1.3, 1.6, 1.10-1.12, 4.2, and Appendices 1-3, 6-7, and 12-15

Preface, 1.1-1.4, 1.10-1.12, 1.15, and Appendices 1-4, 7-12, and 17-19

Articles 2 and 3

Articles 2 and 3, and Letter 1

Quality Requirements

Last content review/update: April 24, 2024

Investigator’s Brochure

In accordance with Decree021-2017, Res655-2019 (which amends Decree021-2017), and Res252-2022 (which amends the INS-CTManual), the sponsor or the contract research organization (CRO) is responsible for providing the investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. As noted in Decree021-2017, the IB must be validated and updated on a regular basis by the sponsor and at least once a year by the responsible team member (if not the sponsor), when new information on the IP—not yet included in the IB—becomes available. Decree021-2017 and the INS-CTManual indicate that the updated IB should be sent to the National Institute of Health (Instituto Nacional de Salud (INS))’s Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) (formerly known as the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT))), the ethics committees (ECs), and the principal investigators (PIs). The INS-CTManual further specifies that the sponsor or the CRO is required to submit a signed notification form (FOR-OGITT-059) to inform the DIIS of any IB updates (PER-41). The form must be accompanied by an update report of the applicable IP(s).

As specified in Decree021-2017, the IB must provide coverage of the following areas:

Physical, chemical, and pharmaceutical properties and formulation parameters
Non-clinical studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
Clinical studies (pharmacokinetics, metabolism, pharmacodynamics, dose response safety, efficacy, and other pharmacological activities; safety and efficiency)
Post-marketing experience (e.g., countries where the IP has been marketed or approved or did not receive approval/registration, was withdrawn, or registration was suspended; any significant information arising from marketed use; potential risks and adverse reactions)
Publication and report references

See Annex 2 of Decree021-2017 for detailed content guidelines.

In addition, per the G-SafeRpt, the sponsor or the CRO must ensure that the IB specifies and lists the adverse events (AEs) observed with the IP and for which there is a confirmed or suspected causal relationship. Refer to the G-SafeRpt for detailed safety information to include in the IB.

Quality Management

As specified in Decree021-2017, Res655-2019, and the INS-CTManual, the INS requires the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM) to assess the safety and quality of the IP to be used in a clinical trial as part of its application review and approval process. The ANM's evaluation is based on its review of the IB, the research protocol, and the information related to the IP quality per Annex 2 of Decree021-2017. (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)) (PER-109)). Additionally, to obtain trial authorization, per Decree021-2017, the INS-CTManual, and Res252-2022, the sponsor or the CRO is required to provide quality information regarding the IP in compliance with the requirements in Annex 5 of Decree021-2017. As specified in Annex 5, the following documents relating to the IP must be submitted:

Labeling information
Certificate of batch release analysis or documents that include technical specifications of the batch/series result of the finished product
Accelerated or long-term stability studies as appropriate
Current certificate of the good manufacturing practices of the IP manufacturer, issued by the competent authority of the country of origin or document that guarantees its compliance

For detailed information on submission requirements for comparator IPs and complementary products, refer to Annex 5 of Decree021-2017.

VII

Chapter VII (7.8.4), Chapter IX, and Annex 4 (Flowcharts No. 04 and No. 15)

Annex B

Requirements for Initiating the Procedure (9-10 and 13), 4.1-4.4, and Annex 9

Title I (Articles 2 and 8), Title IV (Article 40), Title V (Articles 67-70), Title IX (Article 108), and Annexes 2 and 5

Last content review/update: March 21, 2024

Investigator's Brochure

In accordance with ClinImprtOrdr, ClinSampleProd, G-ResEthics, G-CT-DIPApp, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28), the sponsor or the designated contract research organization (CRO) is responsible for providing the investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. The sponsor should also update the IB as significant new information becomes available. Per an in-country subject matter expert, Thailand is implementing THA-28. ClinImprtOrdr and ClinSampleProd further state that the IB should comply with the current version of THA-28. Per ClinImprtOrdr, the sponsor is also referred to as the applicant or importer.

As specified in G-ResEthics, ClinImprtOrdr, and ClinSampleProd, and in accordance with THA-28, the IB must provide coverage of the following areas:

Physical, chemical, and pharmaceutical properties and formulation parameters
Non-clinical studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
Effects of IP in humans (pharmacology, pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; regulatory and post marketing experiences)
Summary of data and guidance for the investigator(s)
Bibliography

See Section 7 of THA-28 for detailed content guidelines.

ClinImprtOrdr and ClinSampleProd also indicate that evidence must be provided that the IB has been submitted to the ethics committee. In addition, per G-CT-DIPApp, the applicant must notify the Thai Food and Drug Administration (Thai FDA) of changes to the IB after the import license is granted.

Quality Management

ClinImprtOrdr and ClinSampleProd also state that the IP must be manufactured in accordance with Good Manufacturing Practice (GMP) guidelines.

As stated in ClinImprtOrdr, ClinSampleProd, and the DrugAct, the Thai FDA requires the manufacturer to provide the following (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Evidence of manufacture under conditions compliant with current GMPs
A Certificate of Analysis for each batch of IPs (must be in Thai if the manufacturer is foreign)
A drug registered in a foreign country is required to have a Certificate of Product (CPP)/Certificate of Free Sale (CFS)/evidence of registration from the Drug Control Department from that country and certified by a qualified translator
A Certificate of Free Sale
In the case that the product is approved for marketing authorization in Thailand, provide a copy of certificate of drug registration and evidence that the imported drug and the registered drug are produced by the same manufacturer

Per G-CT-DIPApp, the chemistry, manufacturing and control (CMC) information for an IP submission to the Thai FDA must comply with specific requirements for a new chemical entity. Depending on the phase of the clinical trial, the completed CMC template, as well as the following additional quality information as outlined in the template, must be submitted (Note: The appendices referenced in G-CT-DIPApp are only available as Appendices 7 and 8 in the ClinImprtOrdr and Appendices 7 and 8 in THA-18.)

Additionally, per ClinImprtOrdr, in cases where an applicant submits “Drug quality control and production documents” for drug formulas registered in Thailand, the drug documentation approved by the Thai FDA must be used. When the “Drug quality control and production documents” are for drug formulas registered in other countries, the drug documentation of the specific country should be used. If the documentation is in a language other than English, it should be translated to Thai or English, and certified that the text in other languages matches the Thai/English language. See Appendix 7 of ClinImprtOrdr or THA-18 (Appendix 7) for additional information.

Per G-CT-DIPApp, after the import license is granted, the applicant must also notify the Thai FDA of chemistry and manufacturing or quality changes that do not affect drug quality or safety.

See also THA-18 and THA-76 for the forms included in the appendices in ClinImprtOrdr and ClinSampleProd.

Refer to the Product Management section for additional information on IP supply, storage, and handling requirements, and the Submission Process and Submission Content sections for detailed application requirements.

Appendices 1, 6-7, and 12

Appendices 2, 7-8, 11, and 18

1.36, 5.14, and 7

Annex 5 (6.2, 12.2, and 13)

3, 6, 10, and 14.1

Chapter III (25 and 27)

Preface, 1.6, 1.8, 1.10-1.11, and Appendices 1, 6-7, and 12

1.7-1.8, 1.11, and Appendices 2, 7-11, and 16

Labeling

Last content review/update: April 24, 2024

Investigational product (IP) labeling in Peru must comply with the requirements set forth in Decree021-2017. Labels for IPs used in a clinical trial must be written in Spanish or English language and printed in indelible ink.

In addition, the following information must be included as a minimum on the product label:

Name, address, and telephone number of the sponsor or contract research organization (CRO)
Trial number and/or trial title
IP name or unique code
Date of IP’s expiration or reanalysis
Manufacturing lot number
Number of units and pharmaceutical form
Route of administration
Special storage and conservation requirements
“For research use only”, “no sale”, or similar wording indicating the IP is clinical trial material

The inner labeling of the IP should contain:

IP name
Active ingredient concentration
Route of administration
Manufacturer's name or logo
Batch number and expiration date

In double-blind trials where the IP character, lot number, and manufacturer’s name are not included on the label, the package must include a document that links to information that identifies possible blinded treatments. Furthermore, the labeling must indicate the most restrictive storage requirements on both products. (See the Product Management section for additional information on IP supply, storage, and handling requirements).

Title VI (Article 91)

Last content review/update: March 21, 2024

Investigational product (IP) labeling in Thailand must comply with the requirements set forth in ClinImprtOrdr, ClinSampleProd, G-ResEthics, G-CT-DIPApp, the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28). Per an in-country subject matter expert, Thailand is implementing THA-28. G-ResEthics and THA-28 state that the IP must be coded and labeled in a manner that protects blinding, if applicable. In addition, per G-CT-DIPApp, if a drug product is registered in Thailand, a certified copy of a certificate(s) of drug registration by the Thai Food and Drug Administration (Thai FDA) must be submitted.

ClinImprtOrdr, ClinSampleProd, and G-CT-DIPApp specify that in general, primary and secondary labels must contain (at least) the following requirements (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

All containers and packaging of all sizes are to use the same format as the actual label
Thai language should be used, except for the drug name/drug code and research project sponsor information, where Thai or English language may be used; in the case of drugs administered by medical study personnel, the label information may be submitted in Thai or English
Drug name/drug code, strength, pharmaceutical form, drug delivery system, unit quantity; in the case of a blind treatment study, the label must specify: “Placebo or [Drug Name/Drug Code] + [Strength]”
Research project code or name
Production model and/or code number to identify components and packaging process
Participant number or treatment number and appointment number (if applicable)
Methods of drug use may refer to documentation specifically describing participants (such as drug use records) or to communicate how medical study personnel can correctly administer the drug product
Name, address, and telephone of the sponsor, contract research organization (CRO), or the investigator (main point of contact for clinical research product information and emergency treatment disclosure), unless the participant receives an identification card displaying this information (with attached documents) and is advised to keep this document in their possession at all times
Statement indicating “for clinical research purposes only” or in other words with the same meaning in the Thai language
Drug storage conditions
Period of use (use as appropriate within the expiration date or retest date) in months/years and in a manner that avoids ambiguity
Statement indicating “keep out of the reach of children” in Thai or in other words meaning the same in Thai, unless the participant is not going to take home the medicine

As described in ClinImprtOrdr and ClinSampleProd, primary labels where the primary packaging is always combined with the secondary packaging, should consist of (at least) the following:

Drug name/drug code, strength, pharmaceutical form, drug delivery system (the dosing route may not be established for the oral solid dosage form), unit quantity, in the case of blind treatment study, specify: “placebo or [drug name/drug code] + [strength]"
Research project code or name
Production model and/or code number to identify the components and packaging procedure
Participant number or treatment number and appointment number (if applicable)
Sponsor/CRO/investigator name

Refer to ClinImprtOrdr and ClinSampleProd for additional primary label requirements.

Per ClinImprtOrdr and ClinSampleProd, drug labeling must be carried out in a facility licensed to manufacture drugs and in accordance with the DrugProdReqs (see Appendix 12). As indicated in ClinImprtOrdr and ClinSampleProd, in the case of drug preparation for administration at the research site, new labels must be attached to the drug package to be used (e.g., injectable drug preparations, preparing to dispense drugs to be taken immediately, etc.). The applicant must ensure that the principal investigator (PI) or designee:

Prepare label(s) or label image(s) with appropriate and accurate information for the purposes of the research project
Prepare a standard operating procedure (SOP) manual or a standardized method for preparing drugs and labeling drugs in accordance with the rules and methods for producing modern drugs
Ensure the SOPs are administered by a pharmacist or other health professional at the research site who has received appropriate training
Provide evidence to document that practices have been inspected by a second party under strict labeling control
Preserve evidence and record various related documents to support inspection by the authorized person or the Medicines Regulation Division

The applicant does not need to submit a label in this case along with the request, but must ensure that the PI or designee complies with these requirements and is always available for inspection or inspection of the research.

Per ClinImprtOrdr, for labels on drugs authorized for importation or ordering into Thailand for research purposes and that have been submitted to the Medicines Regulation Division, the applicant may refer to the original application document if there is no change from the original submission. As described in ClinImprtOrdr, in the case of a request to change the information on the duration of drug use, an additional label indicating the new date and using the original production version should be added. The new label(s) or label image(s) should be submitted in the same format as the original label used, which may cover the original date. However, the new label must not cover the original production version for quality control reasons, and the labeling must be performed at a facility licensed to manufacture the drugs. If necessary, the on-site labeling requirement may be waived. In such cases, the drug must be labeled by a pharmacist or other health professional at the site, or an appropriately trained research supervisor.

Similarly, per ClinSampleProd, for drug labels previously submitted to the Medicines Regulation Division to produce drug samples for human research studies, the applicant may refer to the original document, if it has not been amended. Additionally, the requirements for requesting a change to the period of use on the drug label also follow the same requirements as those delineated for ClinImprtOrdr.

Per ClinImprtOrdr and ClinSampleProd, if necessary, the applicant may request that the Medicines Regulation Division consider a waiver of drug label requirements in the following cases:

Information on drug labels for clinical drug research projects that are conducted in many countries and cannot be changed in a timely manner upon submission of the first authorization request (passing the application review and entry into the system)
Information on the label that may refer to other documents (e.g., reference method of dosage administration, record of drug use, etc.) should be attached to the reference document with an explanation
Additional labeling after the drug is brought into Thailand in order to comply with the requirements for research drug labels: a label(s) or label image(s) must appear in the same format as the actual label; information on the label that may refer to other documents, such as how to give medicine, reference to medication records, etc., by attaching the reference document with an explanation; the place of labeling is a licensed facility to produce the correct drug, or, if necessary, a waiver may be requested for the labeling operation to be in a controlled location instead. In such cases, labeling procedures must be performed by a pharmacist or other research site health professional, or by an appropriately trained research supervisor. Operational procedures and a record of practices should be prepared, and these documents should be checked by a second person. The labeling should be strictly controlled, and operations must be consistent with modern drug production manufacturing guidelines and procedures.

In addition to completing the Request for Drug Waiver in Specific Cases Form (see Appendix 6 of ClinImprtOrdr, Appendix 6 of THA-18, Appendix 5 of ClinSampleProd, or Appendix 5 of THA-76), the reasons should be stated, and the SOPs should be attached.

ClinImprtOrdr and ClinSampleProd state that recommendations for how the drug is to be used should be identified in the protocol for use in accordance with the established indications. If the drug is registered in Thailand as a drug procured from the market in Thailand, there is no need to obtain approval for another production process or packing process. The following should be added to the original container, but not over the original label:

Sponsor, CRO, or investigator name
Research project code
Statements "for clinical research purposes only" or other words synonymous with the Thai language

Appendices 1, 5, 7, and 14

Appendix 2, 6-7, 11, and 18

5.13

Annex 5 (13.1)

3 and 8

1.7 and Appendices 1, 5, 7, and 14

1.6 and Appendices 2, 6-7, 11, and 18

Appendix 12

Product Management

Last content review/update: April 24, 2024

Supply, Storage, and Handling Requirements

Per PER-53, the sponsor or the contract research organization (CRO) should supply the investigator(s)/institution(s) with the investigational products (IPs). Decree021-2017 indicates that the IPs will be dispensed through a Dispensation Unit for Clinical Trials under the Pharmacy Service or Department of the research institution where the trial will be conducted. The dispensation process must comply with the G-GSPs and G-GDPs, and study specifications agreed to by the sponsor. The Clinical Trial Dispensing unit is responsible for:

Inventorying IPs
Controlling overused, used, and unused IPs for final disposal as established in the protocol

Decree021-2017 further indicates that the sponsor or the CRO is responsible for the destruction of the unused and/or returned IP. The IP must not be destroyed without the sponsor’s or the CRO’s prior written authorization, and any discrepancy in their final accounting has been investigated, explained, and resolved. Refer to Decree021-2017 for additional IP and complementary product destruction requirements. See also PER-41 for the notification form (FOR-OGITT-059) to dispose of IPs.

Additionally, per Decree021-2017, the sponsor must fund IPs for use in trials and provide them free of charge to research participants. See the Insurance & Compensation section for additional information on participant post-trial access to IPs.

Record Requirements

Per Decree021-2017, the sponsor must also keep samples of the IPs, its manufacturing and control protocols, as well as IP records. In addition, all IP destruction procedures must be documented. The records must detail the quantities destroyed and allow the traceability of the IP.

Decree021-2017 further states that the Clinical Trials Dispensing Unit or the Pharmacy Service or Department of the research institution where the trial will be conducted is also responsible for maintaining a record of dates in which IP quantities are received/dispensed.

5.14

Title IV (Article 40), Title V (Articles 67 and 75), Title VI (Articles 92-93 and 96-98)

Last content review/update: March 21, 2024

Supply, Storage, and Handling Requirements

As defined in G-ResEthics and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28), the sponsor or the designated contract research organization (CRO) must supply the investigator(s)/institution(s) with the investigational products (IPs), including the comparator(s) and placebo, if applicable. The sponsor or the designated CRO should not supply either party with the IP(s) until approval is obtained from the Thai Food and Drug Administration (Thai FDA) and the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH), another ethics committee (EC) (e.g., the Central Research Ethics Committee (CREC)), and/or the local EC. The ECMOPH and the CREC are both ECs recognized by the Thai FDA. Per an in-country subject matter expert, Thailand is implementing THA-28.

G-ResEthics and THA-28 specify that the sponsor or the designated CRO must ensure the following:

Timely delivery of the IP(s)
Records maintained for document shipment of the IP(s)
Written procedures including instructions for handling and storage of the IP(s), adequate and safe receipt of the IP(s), dispensing of the IP(s), retrieval of unused IP(s), return of unused IP(s) to the sponsor, and disposal of unused IP(s) by the sponsor
IP product quality and stability over the period of use
IP manufactured according to any applicable Good Manufacturing Practices (GMPs)
Proper coding, packaging, and labeling of the IP(s)
Acceptable IP handling and storage conditions and shelf life

Refer to the G-ResEthics and THA-28 for detailed, sponsor-related IP requirements. As defined in G-ResEthics and THA-28, the sponsor is also accountable for supplying the IP, including the comparator(s) and placebo, if applicable.

Record Requirements

As per G-ResEthics and THA-28, the sponsor should inform the investigator(s) and institution(s) in writing of the need for record retention and should notify the investigator(s) and institution(s) in writing when the trial related records are no longer needed. Additionally, the sponsor must ensure sufficient quantities of the IP(s) used in the trial to reconfirm specifications, should this become necessary, and should maintain records of batch sample analyses and characteristics. All sponsor-specific essential documents should be retained for at least two (2) years after formal discontinuation of the trial or in conformance with applicable regulatory requirements.

1.33, 4.9, 5.5, 5.13-5.14, and 7

Annex 5 (5.11, 6.2, 13, and 14)

Definition of Specimen

Last content review/update: April 24, 2024

No relevant provisions are currently available that define specimens.

However, as noted in Decree021-2017, standards relating to biological samples to be used in clinical trials will be approved in a forthcoming National Institute of Health (Instituto Nacional de Salud (INS)) resolution.

Supplementary Provisions—Final (Sixth)

Last content review/update: March 21, 2024

In Thailand, a specimen is generally referred to as biological material. As delineated in G-ResEthics, biological material is defined as original material, progeny, and unmodified derivatives. In the Material Transfer Agreement template provided in G-ResEthics, material covered by the agreement includes all living or dead biological materials and any replicated or derived cells or DNA molecules.

G-ResEthics collectively classifies biomedical research as those studies that include information from a participant’s medical records or databases; laboratory specimens; bodily fluids; human tissues; and studies about the physiology, biochemistry, pathology, biochemistry, and psychology of typical participants.

In addition, G-ResEthics specifically defines human tissue samples as anything being taken out or excreted from a human body or a corpse. These samples may also include other tissues, blood, secretions, and excretions from all organ systems to be used for the diagnosis of a disease or for other purposes.

Please refer to G-ResEthics for more specific definitions for selected terms including progeny and unmodified derivatives.

1.4, 7.5-7.7, and Annex 8

Specimen Import & Export

Last content review/update: April 24, 2024

No relevant provisions are currently available regarding the import or export of specimens.

However, as noted in Decree021-2017, standards relating to biological samples to be used in clinical trials will be approved in a forthcoming National Institute of Health (Instituto Nacional de Salud (INS)) resolution.

Supplementary Provisions—Final (Sixth)

Last content review/update: March 21, 2024

Import/Export

No information is currently available regarding the Thai Food and Drug Administration (Thai FDA)’s role in approving the import and export of biological specimens.

Material Transfer Agreement

G-ResEthics states that in the case of the transfer of biological materials, the sponsor must complete the Material Transfer Agreement (MTA) form (Annex 8) to obtain or transfer biological materials for research purposes. An MTA form must also be used to transfer human tissue samples to other institutions.

See also THA-13 for the Material Transfer Agreement and Material Transfer Record forms provided by the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH).

Per THA-34, the Central Research Ethics Committee (CREC) requires investigators to include an MTA in the initial protocol submission package in cases where specimens are sent to an outside research institute. The MTA must be uploaded to the CREC online submission system (THA-43) using the form required by each institute. This document will be used by the CREC for consideration, but it is not endorsed.

The ECMOPH and the CREC are both ethics committees approved by the Thai FDA to review and approve clinical trial protocols.

Material Transfer Agreement (p. 83) and Material Transfer Record (p. 87)

Supporting Documents - 22. Material Transfer Agreement

7.5 and Annex 8

Consent for Specimen