Thai Food and Drug Administration

As per the DrugAct, ClinDrugReqs, and ClinDrugReqsDetails, the Thai Food and Drug Administration (Thai FDA) is the regulatory authority responsible for controlling the import of drugs for research purposes, and also uses this authority to indirectly regulate drug clinical trials in humans.

As set forth in the DrugAct, THA-33, and THA-49, the Thai FDA is a regulatory body under the Ministry of Public Health (MOPH)'s Cluster of Public Health Service Support, and is granted control by the MOPH to protect consumer health. The agency is also authorized to ensure the quality, safety, and efficacy of health products including foods, drugs, cosmetics, and medical devices in Thailand.

In addition, per the DrugAct’s 2019 amendments and according to THA-6, the MOPH has the authority to establish and/or amend drug research-related procedures, regulations, and conditions via Government Gazette announcements. The Thai FDA’s Secretary-General is also permitted to control drug research study activities by issuing temporary suspensions, requesting specific improvements, or completely discontinuing a study that fails to comply with the Minister’s published guidelines.

As indicated in the DrugAct and THA-32, the Thai FDA’s Medicines Regulation Division is a member of the Drug Board (also referred to as the Drug Committee in the English translation of the DrugAct). Per the DrugAct, the board must consist of MOPH departmental directors-general and representatives from related organizations, as well as five (5) to nine (9) drug experts. Every two (2) years, the Minister of Public Health appoints the Committee, which is chaired by the Permanent Secretary of the MOPH. As delineated in THA-32, the 14 members of the board have appointed 20 subcommittees to assist in the board’s responsibility for advising the Minister on regulatory issues and ensuring drug control. Of these subcommittees, the subcommittee on approval of manufacturing or importing medicines for clinical studies is directly involved with the clinical trial and drug import registration process.

The DrugAct also indicates that the board should appoint a subcommittee to study the drug review and approval process. The subcommittee should include at least the following: an office representative and Office of Consumer Protection Board representatives including association, foundation, and drug industry representatives whose purpose is to produce, sell, import, or order drugs for use in Thailand. THA-32 provides the current list of subcommittees, including the subcommittee on review and approval for the registration of modern medicines for human use and the subcommittee on approval of manufacturing or importing medicines for clinical studies.

THA-49 further explains that the Medicines Regulation Division is in charge of reviewing licenses to import or prescribe drugs used for clinical research in Thailand that are exempt from drug registration, issuing licenses to produce a sample drug for registration, and issuing licenses to import or prescribe drug samples for research purposes in Thailand. See THA-49 for additional information on the Medicines Regulation Division’s responsibilities.

As described in the G-CT-DIPApp, the Thai FDA’s International Affairs and Investigational New Drug Section within the Medicines Regulation Division is responsible for application review and recommendation for approval. Per the ClinDrugReqsDetails, and according to the Thai FDA’s organizational structure depicted in THA-33, the Secretary-General of the Thai FDA then makes the final decision to approve the application.

Division of Innovative Health Products and Services

As explained in ClinDrugImprt, the Thai FDA established the Division of Innovative Health Products and Services for the promotion of health product innovations. Its mission and responsibilities include operations relating to licensing the manufacture and import of drugs for research. The Division is also tasked with developing laws, regulations, and innovative health product licensing processes for products researched and developed in Thailand. Per THA-66, the Division also houses the agency’s One Stop Service & Consultation Center (OSSC) (THA-35) within the Comprehensive Health Products Service Center. OSSC services include providing preliminary consultations, processing product application submissions (e.g., applications submitted to obtain drug import licenses for clinical trial purposes), and handling payment services (e.g., permissions and licensing) for various health products including drugs. See the Submission Process section for more details on the import application submission process.

Contact Information

Per FacilDrugReqs, the Thai FDA’s contact information is as follows:

Coordinators: Ms. Somjai Thaijua and Ms. Akanit Wepeewutikorn

Medicines Regulation Division (Clinical Research Drugs)
Food and Drug Administration
Ministry of Public Health
88/24 Tiwanon Road
Muang District, Nonthaburi 11000

Email: ind.thaifda@gmail.com
Phone/Fax: 0 2590 7061

Overview

In accordance with the DrugAct, ClinDrugReqs, and ClinDrugReqsDetails, the Thai Food and Drug Administration (Thai FDA) is responsible for overseeing the importation or prescription of drugs for clinical research purposes, and also uses this authority to indirectly regulate drug clinical trials in humans. 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 ClinDrugReqsDetails, ClinDrugReqs, ClinDrugProd, ClinDrugImprt, ECRegProc, and G-CT-DIPApp, the Thai FDA’s approval of a drug import license is dependent upon obtaining proof of ethics committee (EC) approval to conduct the clinical trial by a Thai FDA approved EC. ClinDrugReqsDetails and THA-69 further specify that the application is submitted to the Thai FDA after 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.

Clinical Trial Review Process

As set forth in ClinDrugReqsDetails, ClinDrugProd, ClinDrugReqs, and G-CT-DIPApp, the Thai FDA coordinates the review of applications submitted to obtain drug import licenses for clinical trial purposes. Per PubGuide-Drug, PubGuide-BioDrug, and 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 New Drug Section. After administrative processing and troubleshooting, 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 he/she determines the package is technically correct, then the reviewer will forward the drug import license application for clinical trial purposes to the Thai FDA’s Secretary-General. (See Submission Process and Timeline of Review sections for details on the administrative and technical processing and review timelines.)

In addition, ClinDrugReqsDetails, ClinDrugProd, ClinDrugReqs, and ClinDrugImprt further specify that once the Thai FDA receives the EC approval documentation, the agency will complete its review within 15 days. See also the Timeline of Review and Manufacturing & Import sections for import license renewal requirements.

According to ClinDrugReqs, ClinDrugReqsDetails, ECRegProc, ClinDrugProd, ClinDrugImprt, and the DrugAct, the Thai FDA’s approval of a drug import license application for clinical trial purposes also serves as an import license that allows the sponsor to import investigational drugs into Thailand. According to ClinDrugReqsDetails, ClinDrugReqs, ClinDrugProd, and ClinDrugImprt, the import license will expire in four (4) years from the date of issuance. However, the DrugAct states that a license will remain valid until December 31^st of the year of issue. The license holder who would like to renew his/her license must file an application for renewal prior to the license expiration date. ClinDrugReqs, ClinDrugProd, and ClinDrugImprt further note that if the study is still ongoing after the expiry date or the amount of drug is insufficient, the sponsor can resubmit the application. (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 Additional Amendment/Clarification Request Form (Appendix 12 of G-CT-DIPApp) are also required. (Note: At this time, Appendix 12 is only available in the ClinDrugReqsDetails.)

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.

See THA-18 for the application form for permission to import or prescribe drugs for research purposes in Thailand, and THA-51 for details on & OSSC’s online Consultation E-service System.

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 prescribe 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 prescribe drugs for research purposes in the country
• Applications to expand the scope of a license to produce sample investigational drugs to register new drugs for human research studies

In addition, 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 prescribe drugs for research purposes in the country or to request permission to register and produce sample investigational drugs for human research: 4,000 Baht
• Application to amend and request specific changes related to either of the application requests listed in preceding bullet: 500 Baht
• Application to expand the scope of a license to produce sample investigational drugs and register new drugs for human research studies: 1,000 Baht
• New research drug application to expand the scope of a license to produce sample investigational drugs and register a new drug for human research studies: 4,000 Baht

Payment Instructions

As delineated in G-ElecSubs, applicants should submit payment for the Thai FDA’s processing of an application for a license to prescribe or import drugs into the country that are exempt from drug registration using the Nor Yor Mor 1 form (THA-18). Following receipt of a fee payment order through electronic mail (email) from the Office of the Registrar, the applicant pays the fees via the Thai FDA’s One Stop Service & Consultation Center (OSSC) (THA-35) using the e-submission link on the Skynet web portal (THA-54), and then submits the proof of payment documents by replying to the original email. Refer to THA-57 for the Skynet user manual.

Overview

As per ClinDrugReqsDetails, ClinDrugReqs, ClinDrugProd, ClinDrugImprt, ECRegProc, and G-CT-DIPApp, 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)). As listed in THA-9, THA-12, and THA-53, as of 2021, the Thai FDA has approved or renewed the approval of 12 private hospital/institutional ECs.

Central Ethics Committees

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 human subjects. 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.

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. In addition, as described in THA-44, the focus of the CREC is on reviewing multi-center clinical research projects to enable the projects to be initiated more quickly and efficiently. The CREC’s primary duties and responsibilities center on developing cooperation between the ECs of each participating department/organization and institution; advocating for speed and efficiency in the review of clinical human research projects in Thailand; and promoting and supporting international human research ethical standards. As discussed in THA-63, the ECMOPH and the CREC are collaborating on a multi-institution clinical research project to reduce redundancy during the review process and to develop joint human research ethics guidelines. See THA-44 for additional information on the CREC and THA-36 and THA-37 for detailed CREC submission requirements.

Per THA-39, the ECMOPH is also 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.

ECRegProc states that the Thai FDA posts a list of the approved/renewed ECs on its website, and as noted in THA-3, this usually occurs every two (2) years. According to THA-4, although not listed in the 2018 Thai FDA approval/renewal list, the ECMOPH and the CREC are both government ECs whose approvals are still active.

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.

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 subjects, 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.

Per EC-Forms, the Thai FDA has issued the following forms to be completed by the EC:

• Self-Verification Form for Requesting Research Ethics Committee Acceptance on Drug Clinical Trial Considerations (THA-58)
• Sources of Income Disclosure and Receipt and Payment Regulations of the Human Research Ethics Committee (THA-59)
• Certificate of No Conflict for the Human Research Ethics Committee (THA-60)

Also, refer to THA-37 for a complete list of CREC SOPs.

Overview

Pursuant to ClinDrugReqsDetails and ECRegProc, Thai Food and Drug Administration (Thai FDA) recognized ethics committees (ECs) are responsible for reviewing and approving protocols for clinical research related to drugs to be imported into Thailand. The Thai FDA will review the drug import license application for a study drug that must only be used for research at the specific study site approved by a Thai FDA-recognized EC.

As stated 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 the Thai FDA recognized ECs relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. 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. The 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.

In addition, per ClinDrugReqsDetails, the Ministry of Public Health (MOPH) may also establish an academic EC or subcommittee for research on certain drugs requiring special supervision (e.g., for AIDS vaccines and drugs derived from cells). See the Submission Process section for submission requirements.

Role in Clinical Trial Approval Process

As stated in ClinDrugReqsDetails, ClinDrugReqs, ClinDrugProd, ClinDrugImprt, ECRegProc, and G-CT-DIPApp, the Thai FDA’s approval of a drug import license application to conduct a clinical trial is dependent upon obtaining approval by a Thai FDA approved EC. ClinDrugReqsDetails and THA-69 further specify that the application is either submitted to the Thai FDA after 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.

ClinDrugReqsDetails, ClinDrugProd, ClinDrugReqs, and ClinDrugImprt also explain that once the Thai FDA receives the EC approval documentation, the agency will complete its review within 15 days.

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 CREC website (THA-36).

As set forth in the CRECFees, the Central Research Ethics Committee (CREC), one (1) of the ethics committees (ECs) recognized by the Thai Food and Drug Administration (Thai FDA), requires investigators to pay a nonrefundable fee to submit a clinical trial research protocol for ethical review and approval.

The CRECFees specifies the following fees for the ethical review of privately funded research projects:

• New research project: 50,000 Baht
• Request for certification renewal: 20,000 Baht
• Research projects amended by the CREC that require a local EC to re-approve the revised project: fee determined by local institution

For research projects funded by government agencies, royal colleges, or medical professional associations, the CRECFees delineates the following fees:

• New research project: 25,000 Baht
• Request for certification renewal: 10,000 Baht
• Amended research project review: 5,000 Baht
• Research projects amended by the CREC that require a local EC to re-approve the revised project: fee determined by local institution

In addition, the CRECFees explains that investigators should submit ethics application fee payments to the following bank:

Krung Thai Bank Account
Payment to the order: The Foundation for Promotion of Human Research in Thailand
Savings account number: 981-2-84782-0

The investigators must submit proof of payment with the application submission. 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-36 further notes that the CREC will confirm receipt of fee payment after the 10^th of the following month. Investigators can contact the CREC to check on the status of their fee payment by sending an email to the following contact:

Thimpika Nimkham
Phone: 09 8564-7497
Email: timpika.nimkham.crec@gmail.com

Per THA-36, if the CREC has no evidence of payment, the application submission will be considered incomplete.

Overview

As indicated in ECRegProc, ClinDrugReqsDetails, ClinDrugReqs, and ClinDrugProd, 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. ClinDrugReqsDetails and ECRegProc specify that authorized ECs are responsible for reviewing and approving protocols for clinical research involving drugs to be imported into Thailand.

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.

As listed in THA-9, THA-12, and THA-53, as of 2021, the Thai FDA has approved or renewed the approval of 12 private hospital/institutional ECs. ECRegProc states that the Thai FDA posts a list of the approved/renewed ECs on its website. These ECs are in addition to the centralized ECMOPH and the CREC.

Registration, Auditing, and Accreditation

No information is available.

Overview

In accordance with ClinDrugReqs, ClinDrugReqsDetails, ClinDrugProd, ClinDrugImprt, and G-CT-DIPApp, the sponsor or his/her contract research organization (CRO) is responsible for submitting a drug import license application to the Thai Food and Drug Administration (Thai FDA). As set forth in ClinDrugReqsDetails, ClinDrugReqs, ClinDrugProd, ECRegProc, and G-CT-DIPApp, the Thai FDA’s approval of a drug import license is dependent upon obtaining proof of ethics committee (EC) approval to conduct the clinical trial by a Thai FDA-approved EC. ClinDrugReqsDetails and THA-69 further specify that the application is submitted to the Thai FDA after 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 ClinDrugReqsDetails, the sponsor is also referred to as the applicant or importer.)

Regulatory Submission

Per PubGuide-Drug and FacilDrugReqs, applicants should submit drug import license applications electronically to the Thai FDA’s Medicines Regulation Division for review and approval via the Thai FDA’s One Stop Service & Consultation Center (OSSC) (THA-35) using the Skynet web portal (THA-54). THA-18 provides access to the clinical trial/drug import license application form that the Thai FDA refers to as the Application Form for Permission to Import or Prescribe Drugs for Research Purposes in the Kingdom (Nor Yor Mor 1 form).

FacilDrugReqs notes that applications in PDF format may also be submitted via e-mail using the Skynet Smart Drop box (THA-70) or by postal mail that specifies the name of the attorney to send documents along with a phone number and e-mail to be used for coordination. FacilDrugReqs further states that clarifications and inquiries regarding the application review process are conducted by telephone, email, or the LINE communication application (see THA-56 for additional information on LINE); general consultations are to be handled by telephone. The OSSC also provides an online Consultation E-service System (THA-51) for user inquiries (see THA-65 for the Consultation E-service manual). See also THA-57 for the Skynet user manual, and THA-71 for the Skynet Smart Drop box guide.

The Thai FDA accepts paper and electronic clinical trial application submission packages. As per ClinDrugReqsDetails, PubGuide-Drug, and PubGuide-BioDrug, for paper submissions, sponsors must submit two (2) original sets and one (1) copy of the completed Nor Yor Mor 1 form (THA-18) to the Thai FDA as well as one (1) complete set of application files (MS Word or PDF) on a CD. The files should be arranged in the order that corresponds with the document checklist (Appendix 3 of ClinDrugReqsDetails). Per ClinDrugReqsDetails, the CD should also include copies of all the filed documents (Microsoft Word and PDF files), Microsoft Excel files for the Logistic Systems, and the manufacturer’s files to be completed on Form 11.1 (refer to Appendix 8 - Quality control and drug production documents). G-CT-DIPApp also states that two (2) sets of the application package must be submitted to the Thai FDA.

ClinDrugReqsDetails, PubGuide-Drug, PubGuide-BioDrug, and G-CT-DIPApp indicate that Thai and English are the preferred languages for use in preparing an application package. The following requirements are specified (Note: The regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source):

• The packaging and labeling information should be presented in Thai or English
• The protocol synopsis must be submitted in Thai
• The detailed study protocol specification (completed version of study protocol) may be in Thai or English
• The patient information sheet must be in Thai
• Drug labels of all sizes in Thai or English
• The Certificate of Free Sale must also be presented in English and translated by a trusted certification authority and any other language in which it has been originally issued; and the progress report must be submitted in Thai

See the Submission Content section for detailed information on documentation to be submitted.

The G-ElecSubs, in turn, states that the application and supporting documents should be submitted via email to hpi2017@fda.moph.go.th. G-ElecSubs provides additional guidelines on electronically submitting an application for a license to prescribe or import exempt unregistered drugs using THA-18. The application may be prepared using PDF format (version 1.4 and above) and contain the documents in accordance with the specified electronic Common Technical Document (eCTD) folder structure (see G-ElecSubs for the downloadable folder structure attachment link) by sending the folder structure files containing the stated documentation via email to hpi2017@fda.moph.go.th.

As delineated in G-ElecSubs, officers within the Office of the Registrar receive the application, issue a receipt number in the system, send a fee payment order to the applicant via email, and consider the request for permission. The applicant pays the fees via THA-54 and submits the proof of payment documents by replying to the original email. The officers then record the license request in the database and the results of the request in the information system to which it is linked using the License Per Invoice (LPI) system (see THA-55 for LPI access instructions). The Office of the Registrar will then submit the license request results to the applicant via email. The applicant can proceed to apply for permission to the Thai FDA to import drugs and reference the email received that exempts the applicant from the requirement of having to apply initially for drug registration.

In the event that the applicant needs the original license document, the original copy can be requested using one (1) of the following options: (1) the aforementioned proof of payment for the application documents can be sent to the Office of the Registrar by mail, whereby the officers will send the original signed documents back via postal mail or coordinate with a messenger to have the documents delivered at the address the applicant provided in his/her application (in this case, the applicant will be responsible for the messenger delivery cost); or (2) the applicant or an authorized person representing the applicant, including a messenger, can obtain the original license document at the e-CTD Desk, Floor 5, Building 6, by making an appointment in advance with the staff. Otherwise, the applicant can wait until the signed documents are returned by mail as discussed earlier.

Per FacilDrugReqs and THA-68, the following is contact information for submitting an application to the OSSC (THA-35) via email or postal mail:

Coordinators for Medicine Applications:
Mrs. Ratchada Phatthanasombatsakul (Submitting an application for permission)
Ms. Patcharaphan Kitphan (Registering in case of transfer)
Ms. Sineenart Uamsamang (Issuing a certificate)
Ms. Hathairat Kaewaramsri (General consultation)

Medicines Regulation Division (OSSC)
Food and Drug Administration
Ministry of Public Health
88/24 Tiwanon Road
Muang District, Nonthaburi 11000

Email: ossc_drug@fda.moph.go.th
Phone: 02 590 7620-1 (Submission of an application)
Phone: 02 590 7619 (General consultation)
Phone: 02 590 1556 press 3 (FDA Hotline (Call Center))

Per THA-67, to resolve any health product licensing problems, applicants may contact the OSSC by email, postal mail, phone, or by downloading the request form on the website. The OSSC can be contacted at:

Public Relations Officer
Comprehensive Health Products Service Center
OSSC
Building 6
Floor 4 and Floor 5

Email: ossc@fda.moph.go.th
Phone: 02 590 7628, 02 590 7430

Refer to FacilDrugReqs for additional application submission contact information. 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 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, which is one (1) of the ECs recognized by the Thai FDA to approve clinical research protocols, 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-37 indicates that investigators applying for a new research project should submit an application electronically to the CREC for review via its Online Submission System (THA-43). Refer to THA-37 for detailed application package documentation requirements as well as a comprehensive list of all the CREC Standard Operating Procedures (SOPs).

Per THA-37, the CREC requires the protocol to be submitted in Thai and/or the complete English version specifying the version and date; the Thai version should be submitted if only the complete English outline of the proposal is included.

In addition, per ClinDrugReqsDetails, the Ministry of Public Health (MOPH) may also establish an academic EC or subcommittee for research on certain drugs requiring special supervision (e.g., for AIDS vaccines and drugs derived from cells). Therefore, when submitting an application to request permission to import or prescribe this type of drug for clinical research, an additional approval letter from this committee is also required.

Regulatory Authority Requirements

As per ClinDrugReqsDetails, PubGuide-Drug, PubGuide-BioDrug, and G-CT-DIPApp, sponsors must submit one (1) original set and two (2) copies of the following documents to the Thai Food and Drug Administration (Thai FDA) (Note: The regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source):

• Cover letter
• Application for Permission to Import or Prescribe Drugs for Research Purposes in the Kingdom (Nor Yor Mor 1 form) (THA-18)
• Checklists and Attached Documents for THA-18
• Drug labels for every container (Thai or English)
• Package inserts (for registered drugs)
• Prescriptions (for registered drugs)
• Investigator’s Brochure (IB) (for unregistered drugs)
• Information Consent Certificate (Thai)
• Patient Information Sheet (Thai)
• Protocol synopsis (Thai)
• Completed version of study protocol (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 not available, per ClinDrugReqsDetails, ClinDrugProd, ClinDrugReqs, and ClinDrugImprt, the EC review must be submitted to the Thai FDA no later than 15 days after the authorized person receives this decision)
• Estimates of the amount of study drug, comparators, or other goods to be imported
• Certificate of Analysis
• Certificate of Free Sale (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

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 versions
• Period of approval and/or date of expired approval

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-37, investigators applying for a new research project review by the Central Research Ethics Committee (CREC) should submit the following: (Note: Additional sets of specific documents are also indicated below, if required):

• Research proposal (one (1) set)
• Proposal for ethical consideration (CREC forms AP 04-S04 or AP 05-S04) signed by the investigator/co-investigator (or advisor) (four (4) sets)
• Research protocol transcript (in Thai and/or the complete English version specifying the version and date); or the Thai version if only the complete English outline of the proposal is included (four (4) sets)
• Documents detailing the joint research project data/books consent (e.g., the Information Sheet/Consent Form), if required; must include page number/version, date, and details specifying if any participants are children and/or if assent forms are required
• Investigator/co-investigator CVs (four (4) sets)
• Evidence of good clinical practice (GCP) training or research ethics training by PIs/joint investigators (four (4) sets)
• Conflict of Interest Form completed by PIs/joint investigators (CREC form AP 06-S04) (four (4) sets)
• CD containing one (1) copy of research project electronic files

The CREC also requires the following information from pharmaceutical companies submitting proposals for review:

• Researcher guide (IB) (include page numbers, version, and date) (In the case of IB medical device research project, CREC form AP 01-S07)
• IP information (if IPs are used, documentation should include Thai FDA approval information, if available, including Thai FDA certificate number and series)
• Injury compensation insurance documents (indicate if still valid in current year)

Refer to THA-37 for detailed CREC submission requirements.

Clinical Protocol

As delineated in ClinDrugReqsDetails, G-ResEthics, and G-CT-DIPApp, the clinical protocol should include the following elements (Note: The regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source):

• 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 ClinDrugReqsDetails 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 guidance 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, refer to THA-13 and THA-37 respectively for detailed ECMOPH and CREC submission requirements related to the protocol.

Overview

ClinDrugReqsDetails and THA-69 specify that a drug import license application is submitted to the Thai Food and Drug Administration (Thai FDA) after 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.

Regulatory Authority Approval

As delineated in PubGuide-Drug and PubGuide-BioDrug, the Thai FDA’s review and approval process for drugs to be imported for clinical trials takes 20 working days upon receipt of the application. Per the PubGuide-BioDrug, the Thai FDA review and approval process for biological medicines takes 60 days.

As set forth in ClinDrugReqsDetails, ClinDrugProd, ClinDrugReqs, and G-CT-DIPApp, the Thai FDA coordinates the review of applications submitted to obtain drug import licenses for clinical trial purposes. Per PubGuide-Drug, PubGuide-BioDrug, and 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 New 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, then he/she will send a “Screening Result Notification form” to the applicant or his/her attorney for correction. If the applicant or his/her 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 he/she determines the package is technically correct, then the reviewer will forward the drug import license application for clinical trial purposes to the Thai FDA’s Secretary-General. If the reviewer finds the application package technically incorrect, then he/she will forward the application for rejection to the Thai FDA’s Secretary-General. If the reviewer finds the technical information to be incomplete, then he/she will request that the applicant or his/her attorney 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 at a later time. If the applicant can completely correct the application package within the required timeframe, the officer will forward the package to the assigned reviewer for re-assessment.

In addition, ClinDrugReqsDetails, ClinDrugProd, ClinDrugReqs, and ClinDrugImprt further specify that once the Thai FDA receives the EC approval documentation, the agency will complete its review within 15 days. See 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.

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.

Per G-ResEthics, each EC should establish its own requirements for protocol submission and timeline of review. See the Submission Process section for detailed submission requirements.

Overview

In accordance with ClinDrugReqs, ClinDrugReqsDetails, ECRegProc, ClinDrugProd, and ClinDrugImprt, a clinical trial can only commence after a sponsor receives approval of a drug import application from the Thai Food and Drug Administration (Thai FDA) and 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.

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.

Clinical Trial Registration

The ClinDrugReqsDetails application document checklist (Appendix 3) includes clinical trial registry information as one (1) of the items to be included in the application submission package. The summary of research project requirements (Appendix 7) in ClinDrugReqsDetails also specifies 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.

Safety Reporting Definitions

In accordance with ClinDrugReqsDetails, 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 noxious and unintended responses to a medicinal product related to any dose
• 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 (Note: this definition is found in the G-AEReptReqs)
• 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 ClinDrugReqsDetails, ClinDrugReqs, ClinDrugProd, ClinDrugImprt, G-CT-DIPApp, and THA-28, sponsors who are permitted to import or prescribe drugs for research in Thailand and those who are licensed to produce drugs, must comply with the Thai Food and Drug Administration (Thai FDA)’s safety monitoring and reporting requirements. ClinDrugReqsDetails states 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 risks, IP changes, or changes required in trial operations as a whole
• SAE/SADR incidents that never occurred before, or, with the level of severity
• Participants harmed by IPs used to treat life-threatening conditions who have experienced no significant benefits
• Significant new information about experimental animal safety studies

Per ClinDrugReqsDetails, 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 six (6) days from the first knowledge of the incident’s occurrence. Any additional relevant information should be sent within seven (7) 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

Refer to THA-22 for the Health Product Adverse Event Report Form.

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 his/her 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 ClinDrugReqsDetails, annual and end of study safety reports must be provided to the Thai FDA’s Medicines Regulation Division. The annual report must be submitted within three (3) months of the one (1) year anniversary of the study, and the final safety report must be provided within six (6) months after the study has concluded. In addition, a list of all SAE/SADR incidents involving research participant(s) should also 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 20 in ClinDrugReqsDetails for an example of the reporting form.

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:

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

Fax: 02­-5907253 or 02­-5918457
Email: adr@fda.moph.go.th

Pursuant to ClinDrugReqsDetails, individual reports should be submitted electronically via the Thai FDA’s HPVC (THA-30), unless the system is unavailable. 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)

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.

See also THA-8 for additional information on the Thai FDA’s HPVC (THA-30) management of national pharmacovigilance data.

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 propose to the EC how often he/she plans to submit a progress report from the date of protocol submission for ethical review, and this 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 summary report of the research 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 ClinDrugReqsDetails, ClinDrugReqs, ClinDrugProd, and ClinDrugImprt, the sponsor must submit a study progress report annually to the Thai Food and Drug Administration (Thai FDA) between October 1 and 31 every year until the study ends. Per ClinDrugReqsDetails, this report should be submitted using the progress report form in Appendix 15, and accompanied by a delivery letter to the Thai FDA’s Director of the Bureau of Medicine using the format in Appendix 14.

Final Report

As specified in ClinDrugReqsDetails and ClinDrugImprt, in the event of early termination of the research study, the sponsor must submit a summary report (Appendix 19 of ClinDrugReqsDetails) 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.

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 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. THA-28 also states that the sponsor may be a sponsor-investigator if he/she 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 ClinDrugReqsDetails, the sponsor is also referred to as the applicant or importer.

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. Peran in-country subject matter expert, Thailand is implementing THA-28.

Additionally, the sponsor must define and allocate all study related duties and responsibilities to the relevant parties participating in the study. Per an in-country subject matter expert, Thailand is now implementing THA-28. As delineated in THA-28 and G-ResEthics, 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 currently 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 given EC 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

Insurance

ClinDrugReqsDetails specifies that financing and insurance information should be included in the study protocol and protocol synopsis. 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. 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 ClinDrugReqsDetails, G-ResEthics, G-CT-DIPApp, and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (THA-28), the sponsor or his/her 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. The sponsor must also inform the participants of any available medical treatment in the event of trial-related injuries. Per an in-country subject matter expert, Thailand is implementing THA-28.

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.

Quality Assurance/Quality Control

As stated in ClinDrugReqsDetails 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)

ClinDrugReqsDetails, ClinDrugReqs, ClinDrugProd, and ClinDrugImprt state that the trial must be conducted in accordance with the Good Clinical Practice (GCP) and Good Laboratory Practice principles (GLP).

Monitoring Requirements

As part of its QA system, G-ResEthics and THA-28 note that the sponsor may choose to perform a clinical trial audit. 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 his/her own 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 ClinDrugReqsDetails, ClinDrugReqs, ClinDrugProd, and ClinDrugImprt, 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.

ClinDrugReqsDetails and G-CT-DIPApp also specify that the Thai FDA must be notified no later than 30 working days after the date of discontinuance. G-CT-DIPApp also 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: At this time, Appendices 13 and 14 as referenced in G-CT-DIPApp are only available in the ClinDrugReqsDetails.) As stated in ClinDrugReqsDetails and ClinDrugImprt 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 (Appendix 19 in ClinDrugReqsDetails contains a sample notification form required to be completed when terminating a research project).

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.

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 he/she maintains standard operating procedures for using these systems. Per THA-28, the sponsor should base his/her approach to validate such systems 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. ClinDrugReqsDetails also notes 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 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.

Responsible Parties

For the purposes of data protection requirements, the PDPA delineates responsibilities of the “data controller.” The data controller as defined by the PDPA refers to a person or a 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. The 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. These purposes 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 where they are incapable of giving consent for whatever reason.

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 disease 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, per PDPA, 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 the personal data protection as prescribed by the Personal Data Protection Commission (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 (see the PDPC-Estab and THA-62 for information on the newly established 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.

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 his/her 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. (Note: According to THA-73, the PDPA entered into force on June 1, 2022.)

Consent for Processing Personal Data

As set forth in the PDPA, in the context of complying with data protection requirements, any collection of personal data pertaining to racial, ethnic origin, political opinions, cult, religious or philosophical beliefs, sexual behavior, criminal records, health data, disability, trade union information, genetic data, biometric data, or any other data which may similarly affect the data subject, is prohibited without his/her explicit consent.

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 sponsor is permitted to do so by the provisions of the PDPA or any other laws. 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 of collecting, using, or disclosing his/her 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. See the PDPA for additional guidance on consent requirements.

Per the PDPA, consent to participate in research is not the same as consent as the legal basis for processing personal data under the data protection legislation. However, in the context of complying with data protection requirements, the PDPA states that the data subject may withdraw his/her 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 his/her 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.

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 ClinDrugReqsDetails, 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. As per ClinDrugReqsDetails, 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.)

G-ResEthics and THA-28 state that the investigator(s) or his/her representative(s) must provide detailed research study information to the participant and/or his/her legal representative(s) or guardian(s). 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 his/her legal representative(s) or guardian(s), should also be given adequate time to consider whether to participate.

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 and/or his/her legal representative(s) and/or guardian(s) to waive or to appear to waive his/her 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.

Re-Consent

No information is currently available regarding re-consent requirements.

Language Requirements

As stated in ClinDrugReqsDetails, the ICF content and accompanying information (Patient Information Sheet) should be presented in the participant’s language and must be submitted in Thai and translated to English. 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 and/or the participant’s legal representative(s) or guardian(s), and the investigator(s) must sign and date the ICF. Where the participant is illiterate, and/or his/her legal representative(s) or guardian(s) 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, he/she must 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.

Based on ClinDrugReqsDetails, 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: The regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source):

• The study purpose, procedures, and duration
• 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
• Clinical trial treatment schedule(s) and the probability for random assignment to each treatment
• The disclosure of specific appropriate alternative procedures or therapies available to the participant
• Any benefits or prorated payment to the participant or others reasonably expected from the research; 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
• That participation is voluntary, and that the participant can withdraw from the study at any time without penalty or loss of benefits, including medical treatment, to which the participant is otherwise entitled
• The extent to which confidentiality of records identifying the participant will be maintained, and the possibility of record access by the Thai Food and Drug Administration (Thai FDA), the ethics committees, the auditor(s), and the monitor(s)
• That the participant and/or his/her legal representative(s) or guardian(s) 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 his/her consent
• The consequences of a participant’s decision to withdraw from the research, and procedures for orderly withdrawal by the participant
• Any additional costs to the participant that may result from participation in the research

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.

See the Vulnerable Populations and Consent for Specimen sections for further information.

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. Peran in-country subject matter expert, Thailand is implementing THA-28. ClinDrugReqsDetails, 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 ClinDrugReqsDetails, G-ResEthics, G-CT-DIPApp, and THA-28, the participant or his/her legal representative(s) or guardian(s) should be informed that participation is voluntary, that he/she 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 his/her consent at any time.

The Right to Information

As delineated in ClinDrugReqsDetails, G-ResEthics, the NatHlthAct, G-CT-DIPApp, and THA-28, a potential research participant and/or his/her legal representative(s) or guardian(s) 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

As per ClinDrugReqsDetails, 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 subject, the confidentiality of the patient's information, and to minimize the impacts of the study on the subject.

The Right of Inquiry/Appeal

ClinDrugReqsDetails, G-ResEthics, G-CT-DIPApp, and THA-28 state that the research participant and/or his/her legal representative(s) or guardian(s) should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries.

The Right to Safety and Welfare

G-ResEthics states that a research participant’s right to safety and the protection of his/her health and welfare must take precedence over the interests of science and society.

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

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.

THA-28 explains that in an emergency, if the signed informed consent form (ICF) cannot be obtained from the research participant, the consent of his/her legal representative(s) or guardian(s) should be obtained. If prior consent cannot be obtained from the legal representative(s) or guardian(s), 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 and/or his/her legal representative(s) or guardian(s) 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.

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 and/or his/her legal representative(s) or guardian(s) 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.

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. Per THA-37, according to the Central Research Ethics Committee (CREC), a minor is someone under 18 years of age. The ECMOPH and the CREC are both ethics committees (ECs) recognized by the Thai Food and Drug Administration (Thai FDA).

As set forth in G-ResEthics, when the research participant is a minor, informed consent should be obtained from his/her 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.

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 his or her understanding and, if capable, he or she 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 age 7 until they reach 18. Different assent forms should be created for the following age groups: 7 to 13 and over 13 until 18. Per THA-37, the CREC requires children aged 13 years and older to sign an assent form. The ECMOPH and the CREC are both ECs recognized by the Thai FDA.

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.

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.

Per G-ResEthics, informed consent should be obtained from the legal representatives or guardians of participants for studies involving psychiatric or mentally incapacitated patients.

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 his/her consent. In the case of a patient under 18 years old, or one who lacks the ability to make decisions, the patient’s legal representative(s) or guardian(s) should provide consent. If the patient is to be admitted to a public hospital or treatment facility, his/her 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.

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
• Registered drugs by the national drug authority, but being studied in new doses or indications not previously approved
• Locally produced drugs that require efficacy testing

Manufacturing

According to the DrugAct, ClinDrugReqs, ClinDrugReqsDetails, ECRegProc, ClinDrugProd, and ClinDrugImprt, 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.

ClinDrugReqs, ClinDrugProd, and ClinDrugImprt also state that the IP must be manufactured in accordance with GMP guidelines.

Import

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 trial purposes serves as the import license using the Nor Yor Mor 1 form via THA-18. Per DrugImprtRules-1989 and DrugImprtRules-2009, all requests approved by the Thai FDA to prescribe or import drugs into the country for research purposes are exempt from registration.

According to THA-2, the following documents are also required to be submitted to the Thai FDA:

• Import license application (THA-18)
• Ethics committee (EC) approval letter
• Local importer’s authorization
• Protocol
• Investigator’s brochure (IB)
• Informed consent form
• Package insert
• Label (Thai - necessary, English - optional)
• Quantity estimation for import (Note: Applicant is permitted to request for overages (not more than 20%) in the application)
• Proforma invoice (applies to international exporters)

ClinDrugReqsDetails 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 ClinDrugReqsDetails 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 THA-18 for Nor Yor Mor 1 form), along with supplemental documents as in Appendix 12, are also required. (Note: At this time, the Additional Amendment/Clarification Request Form referenced in G-CT-DIPApp as Appendix 12 is only available in the ClinDrugReqsDetails.)

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 prescribe 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 ethics committee waiver may be required)

See the Regulatory Fees section for information on IP import fees.

Pursuant to ClinDrugReqsDetails, ClinDrugReqs, ClinDrugProd, and ClinDrugImprt, the import license will expire in four (4) years from the date of issuance. However, the DrugAct states that a license will remain valid until December 31^st of the year of issue. The license holder who would like to renew his/her license must file an application for renewal prior to the license expiration date. ClinDrugReqs, ClinDrugProd, and ClinDrugImprt further note that if the study is still ongoing after the expiry date or the amount of drug approved for import is insufficient, the applicant can resubmit the application.

Per the DrugAct, once the renewal application has been filed, the license holder may continue to conduct business unless his/her 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 his/her request. The applicant may obtain a temporary license to operate his/her business until a final decision is issued by the Minister.

Investigator's Brochure

In accordance with ClinDrugReqsDetails, G-ResEthics, G-CT-DIPApp, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28), the sponsor or his/her 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. Per ClinDrugReqsDetails, the sponsor is also referred to as the applicant or importer.

As specified in G-ResEthics and ClinDrugReqsDetails, 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.

ClinDrugReqsDetails also indicates 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 Documentation

ClinDrugReqsDetails, ClinDrugReqs, ClinDrugProd, and ClinDrugImprt also state that the IP must be manufactured in accordance with Good Manufacturing Practice (GMP) guidelines.

As stated in ClinDrugReqsDetails and the DrugAct, the Thai FDA requires the manufacturer to provide the following (Note: The regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source):

• 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: At this time, the Appendices referenced below as being included in G-CT-DIPApp are only available in the ClinDrugReqsDetails):

• For Phase I clinical trial applications, the Quality Overall Summary should include all the information indicated in Appendix 8
• For Phase II clinical trial applications, the Quality Overall Summary should include all the information indicated in Appendix 9
• For Phase III clinical trial applications, the Quality Overall Summary should include all the information indicated in Appendix 10

Refer to THA-18 for additional quality control and manufacturing requirement information to be included in Nor Yor Mor 1 form.

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 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.

Investigational product (IP) labeling in Thailand must comply with the requirements set forth in ClinDrugReqsDetails, G-ResEthics, G-CT-DIPApp, the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28), and Nor Yor Mor 1 form (THA-18). 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.

ClinDrugReqsDetails, THA-18, and G-CT-DIPApp specify that in general, primary and secondary labels must contain (at least) the following requirements (Note: The regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source):

• 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 his/her 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 ClinDrugReqsDetails and THA-18, 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 process
• Participant number or treatment number and appointment number (if applicable)
• Sponsor/CRO/investigator name

Refer to ClinDrugReqsDetails for additional primary label requirements.

As indicated in ClinDrugReqsDetails and THA-18, in the case of drug preparation for administration at the research site, it is necessary to re-label the drug package to be used (e.g., injectable drug preparations, preparing to dispense drugs to be taken immediately, etc.). Per ClinDrugReqsDetails, drug labeling must be carried out in a facility licensed to manufacture drugs and in accordance with the DrugProdReqs (see Appendix 12: Production of Research Pharmaceutical Products). The label(s) or label image(s) created must be submitted to the Medicines Regulation Division in the format of the original label in order to be used at the research site for the purpose of administering drugs. The label(s) should be accompanied by the standard operating procedures (SOPs) used in the preparation and labeling of the drug. Labeling procedures must be performed by a pharmacist, another health professional, or a suitable, 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 is strictly controlled and operations must be consistent with modern drug production manufacturing guidelines and procedures.

Per ClinDrugReqsDetails, for labels on drugs authorized for import or prescription 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 ClinDrugReqsDetails, 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.

Per ClinDrugReqsDetails and THA-18, if necessary, the applicant may request that the Medicines Regulation Division consider a waiver of drug label requirements in the following cases:

• 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; 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 in Appendix 21 of ClinDrugReqsDetails or THA-18, the reasons should be stated, and the SOPs should be attached.

ClinDrugReqsDetails states 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

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 his/her 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 his/her designated CRO should not supply either party with the IP(s) until he/she obtains approval 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 his/her 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.

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.

Import/Export

Information is currently unavailable 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 Material Transfer Agreement and Material Transfer Record forms provided by the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH). The ECMOPH is one (1) of the ethics committees currently approved by the Thai FDA to review and approve clinical trial protocols.

In accordance with G-ResEthics, prior to collecting, storing, or using a research participant’s biological specimen(s), written consent must be obtained from the participant and/or his/her legal representative(s).

As per G-ResEthics, the investigator(s) are responsible for clarifying to the participant and his/her legal representative(s) whether the biological materials collected from the study will be destroyed. If the samples will be used, a clear explanation must be provided as to how the samples will be stored, plans for future use, and whether such use is limited. In addition, the investigator(s) must inform the participants whether any products will be derived from the biological materials collected during the study. (See the Required Elements and Participant Rights sections for additional information on informed consent).

G-ResEthics states that written consent should be obtained from the donor or the giver of the tissue samples. The general requirements for consent must be met, including the investigator(s) obtaining institutional ethics committee (EC) review and approval of the research protocol and for complying with ethical guidelines in compliance with the applicable laws and regulations when conducting research using tissue samples. The guidelines should provide procedures for tissue sample collection, processing, distribution, disposal, and storage for the duration of the research or for future use. The participant or his/her legal representative(s) must be given detailed information about how the samples will be used and stored, and about their right to request the samples be destroyed when the research is complete.

In addition, per G-ResEthics, for retrospective studies using stored human tissue samples, the institution and the EC should establish the rules and regulations to decide when the investigator can waive a donor’s informed consent in order to use stored tissue samples for research. Refer to Section 7.5 of G-ResEthics for detailed information.

G-ResEthics states that the investigator or institution must obtain consent for human genetic research. Investigators and institutions must comply with numerous requirements to ensure participant consent, protection, and privacy rights are upheld with regard to the storage of genetic materials. See Sections 7.6 and 7.7 of G-ResEthics for detailed coverage of genetic research consent requirements.