Clinical Research Regulation For Thailand
Regulatory Authority
Regulatory Authority
Scope of Assessment
Regulatory Fees
Ethics Committee
Ethics Committee
Scope of Review
Ethics Committee Fees
Authorizing Body
Clinical Trial Lifecycle
Submission Process
Submission Content
Timeline of Review
Trial Initiation
Safety Reporting
Progress Reporting
Sponsorship
Definition of Sponsor
Trial Authorization
Insurance
Compensation
Quality, Data & Records Management
Site/Investigator Selection
Informed Consent
Documentation Requirements
Required Elements
Compensation Disclosure
Participant Rights
Special Circumstances/Emergencies
Vulnerable Populations
Children/Minors
Pregnant Women, Fetuses & Neonates
Prisoners
Mentally Impaired
Investigational Products
Definition of Investigational Product
Manufacturing & Import
IMP/IND Quality Requirements
Labeling & Packaging
Product Management
Specimens
Definition of Specimen
Specimen Import & Export
QUICK FACTS
Clinical trial application language Unspecified
Regulatory authority & ethics committee review may be conducted at the same time Yes
Clinical trial registration required No
In-country sponsor presence/representation required Unclear
Age of minors Under 20
Specimens export allowed Unspecified
Regulatory Authority > Regulatory Authority
Last content review/update: August 26, 2020
Requirements
(1) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (DrugAct - Thai) (Last Amended April 16, 2019) (Effective October 13, 2019)
National Assembly
Relevant Sections: Section 4, Chapter I (6-7, 10-11), Chapter II (12), and Chapter V (46)
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for Importing or Ordering Drugs in the Kingdom for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (Effective September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface
(3) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface and Appendices 1-4
(4) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (Effective September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface and 3
(5) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Importing or Placing Medicines into the Kingdom of Thailand Without Registrations, No. 14 (BE 2532) (DrugImprtRules-1989 - Thai) (August 1, 1989)
Ministry of Public Health
Relevant Sections: Article 2 (Clause 3)
(6) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Taking or Placing Medicines into the Kingdom Without Requesting Registration of Drug Formulation, No. 2 (BE 2552) (DrugImprtRules-2009 - Thai) (Effective July 9, 2009)
Ministry of Public Health
Relevant Sections: Article 1 (Clauses 2 and 3)
(7) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Announcement: 2; Notice: Preface, 2-3, and 5
(8) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CT-DIPApp - English, unofficial version) (September 2009)
International Affairs and Investigational Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 2.1
(9) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom for Clinical Research in the Case of Biomedical Drugs (FDA 1) (PubGuide-ClinBiolProdReqs - Thai) (Effective 29/01/2559 in Thai calendar; January 1, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(10) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom For Clinical Research In the Case of Medicines in Humans, Except for Biologic Drugs (FDA1) (PubGuide-ClinDrugReqs - Thai) (Effective 22/06/2559 in Thai calendar; June 6, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
Summary

Overview

As per the DrugAct, TFDA-ClinDrugReqs, DrugImprtRules-1989, DrugImprtRules-2009, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, and TFDA-ClinDrugImprt2017, 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-34, 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 through issuing temporary suspensions, requests for 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 Bureau of Drug Control is a member of the Drug Board (also referred to as the Drug Committee in the English translation of 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. 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 to which this new subcommittee will be added.

As described in the G-CT-DIPApp, the Thai FDA’s International Affairs and Investigational New Drug Section within the Bureau of Drug Control is responsible for application review and recommendation for approval. Per the TFDA-ClinDrugReqs, 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.

As explained in TFDA-ClinDrugImprt2017, the Thai FDA has also established the Institute for the Promotion of Health Product Innovation to carry out activities related to the manufacture and import of drugs for research and to develop related requirements. This profile will be updated as more information becomes available.

Contact Information

Bureau of Drug Control
Food and Drug Administration
Ministry of Public Health
88/24 Tiwanon Road
Mueang District
Nonthaburi 11000
Thailand
Phone: Int. +66 2 590-7171 or Int. +66 2 590-7160
Fax: Int. +66 2 590-7170, +66 2 591-8390, or +66 2 591-8489
Email: drug@fda.moph.go.th

Additional Resources
(1) (Article) Amendments to Thailand’s Drug Act (THA-6) (May 21, 2019)
Homhuan, Atthachai; Tilleke & Gibbons
Relevant Sections: Guidelines for Clinical Research Compliance
(2) (Webpage) Organization Structure of Thai FDA (THA-33) (Current as of August 25, 2020)
Thai Food and Drug Administration, Ministry of Public Health
(3) (Webpage) Thai FDA - Bureau of Drug Control - Laws and Regulations (THA-32) (Current as of August 25, 2020)
Thai Food and Drug Administration, Ministry of Public Health
(4) (Webpage) The Roles and Responsibilities of Thai FDA (THA-34) (Current as of August 25, 2020)
Thai Food and Drug Administration, Ministry of Public Health
Regulatory Authority > Scope of Assessment
Last content review/update: August 26, 2020
Requirements
(1) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (DrugAct - Thai) (Last Amended April 16, 2019) (Effective October 13, 2019)
National Assembly
Relevant Sections: Section 4, Chapter I (10), Chapter II (12, and 17-18), and Chapter V (46)
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for Importing or Ordering Drugs in the Kingdom for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (Effective September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 2-4, and 10
(3) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 1.2-1.3, 1.10, 1.12-1.13, 3, and Appendices 1-7, and 13
(4) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (Effective September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 2-4, and 6
(5) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Importing or Placing Medicines into the Kingdom of Thailand Without Registrations, No. 14 (BE 2532) (DrugImprtRules-1989 - Thai) (August 1, 1989)
Ministry of Public Health
Relevant Sections: Article 2 (Clause 3)
(6) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Taking or Placing Medicines into the Kingdom Without Requesting Registration of Drug Formulation, No. 2 (BE 2552) (DrugImprtRules-2009 - Thai) (Effective July 9, 2009)
Ministry of Public Health
Relevant Sections: Article 1 (Clauses 2 and 3)
(7) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Announcement: 1; Notice: Preface, 2-3, and 5
(8) (Regulation) Notification of the Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 5 and 9-10
(9) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CT-DIPApp - English, unofficial version) (September 2009)
International Affairs and Investigational Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 2-3 and 15
(10) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom for Clinical Research in the Case of Biomedical Drugs (FDA 1) (PubGuide-ClinBiolProdReqs - Thai) (Effective 29/01/2559 in Thai calendar; January 1, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(11) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom For Clinical Research In the Case of Medicines in Humans, Except for Biologic Drugs (FDA1) (PubGuide-ClinDrugReqs - Thai) (Effective 22/06/2559 in Thai calendar; June 6, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(12) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 7
Summary

Overview

In accordance with the DrugAct, TFDA-ClinDrugReqs, DrugImprtRules-1989, DrugImprtRules-2009, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, and TFDA-ClinDrugImprt2017, the Thai Food and Drug Administration (Thai FDA) is responsible for overseeing the importation or ordering 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 TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugImprt2017, ECReg&Proc-2018, and G-CT-DIPApp, the Thai FDA’s approval of a drug importation license is dependent upon obtaining proof of ethics committee (EC) approval to conduct the clinical trial by a Thai FDA approved EC. Per TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the EC approval can be submitted to the Thai FDA after the rest of the application has been submitted for review. Therefore, the Thai FDA and EC may conduct their reviews in parallel.

Clinical Trial Review Process

As set forth in TFDA-ClinDrugReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugLicenseReqs, and G-CT-DIPApp, the Thai FDA coordinates the review of applications submitted to obtain drug import licenses for clinical trial purposes. Per PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, 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. Per G-CT-DIPApp, if the officer finds the package to be incomplete, 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, 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 permit application for clinical trial purposes. If the reviewer finds the application package technically incorrect, then he/she will forward the application for rejection. If the reviewer finds the technical information to be incomplete, then he/she will request that the applicant or his/her attorney to clarify and/or submit additional documents/information. If the documentation or amended information is not submitted within five (5) working days, then the Thai FDA will issue a rejection letter and return the package to the applicant. However, the applicant may resubmit a corrected package to the OSSC 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, TFDA-ClinDrugReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugLicenseReqs, and TFDA-ClinDrugImprt2017 further specify that once the Thai FDA receives the EC approval documentation, the agency will complete its review within 15 days.

According to TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the import license will expire in four (4) years from the date of issuance. TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017 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. The DrugAct states that the issued license shall also cover the license holder’s employees or agents.

As indicated in the DrugAct, a license will remain valid until December 31st 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. 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 sponsor may appeal in writing to the Minister within 30 days from the date of receiving the notice rejecting his/her request. The sponsor may obtain a temporary license to operate his/her business until the Minister issues a final decision.

Applicants may submit import permit applications electronically to the OSSC via the e-submission link (THA-42).

(See the Clinical Trial Lifecycle topic, Submission Content subtopic for submission requirements.)

Additional Resources
(1) (Form) Notification of the Food and Drug Administration Regarding the Requirements for the Importation or Ordering of Drugs into the Kingdom for Clinical Research - Appendices (THA-18 - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Appendix 1: Application Form for Permission to Import or Order Drugs into the Kingdom for Research Purposes (Nor Yor Mor 1)
(2) (Webpage) OSSC - E-submissions (THA-42 - Thai) (Current as of August 25, 2020)
Thai Food and Drug Administration, Ministry of Public Health
(3) (Webpage) Thai FDA - One Stop Service & Consultation Center (OSSC) (THA-35 - English and Thai) (Current as of August 25, 2020)
Thai Food and Drug Administration, Ministry of Public Health
Regulatory Authority > Regulatory Fees
Last content review/update: August 26, 2020
Requirements
No applicable regulatory requirements
Summary

Overview

Clinical trial application fee information is currently not available from the Thai Food and Drug Administration (Thai FDA). However, according to THA-2, charges for the import license application in 2016 were approximately 25000 Thailand Baht.

Additional Resources
(1) (Article) Thailand’s Clinical Trial Regulatory Scenario – Simplified (2/2) (THA-2) (September 26, 2016)
Credevo
Relevant Sections: Import Permit from FDA - Documents Required
Ethics Committee > Ethics Committee
Last content review/update: August 26, 2020
Requirements
(1) (Legislation) Hospital Act, B.E. 2541 (HospitalAct - English, unofficial translation) (Thai) (March 15, 1998)
National Assembly
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for Importing or Ordering Drugs in the Kingdom for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (Effective September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4
(3) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.1-1.3, 1.10- 1.12, 1.15, 5, and Appendices 1-7, 13, and 15
(4) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (Effective September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4
(5) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Announcement: 1; Notice: 4
(6) (Regulation) Notification of the Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4-6 and 9-10
(7) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CT-DIPApp - English, unofficial version) (September 2009)
International Affairs and Investigational Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3 and 15
(8) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Chapter 6
Summary

Overview

As per TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugImprt2017, ECReg&Proc-2018, 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). ECReg&Proc-2018 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)).

Pursuant to TFDA-ClinDrugReqs and ECReg&Proc-2018, an EC is 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 recognized EC.

As listed in THA-9 and THA-12, as of 2020, the Thai FDA has approved or renewed the approval of 11 ECs. ECReg&Proc-2018 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.

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 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. As described in THA-44, the focus of the CREC is on reviewing multi-center clinical research projects in order 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.

Per THA-39, in addition to the ECMOPH’s role in reviewing and approving clinical research projects involving human subjects, the committee 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.

Per TFDA-ClinDrugReqs, 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 order this type of drug for clinical research, an additional approval letter from this special committee is also required.

EC 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

ECReg&Proc-2018, 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 now 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 ECReg&Proc-2018, 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.

(For detailed EC requirements and information on other administrative processes, see G-ResEthics and ECReg&Proc-2018.)

Also, refer to THA-38 for a complete list of CREC SOPs.

Additional Resources
(1) (Article) Thailand’s Clinical Trial Regulatory Scenario - Simplified (1/2) (THA-1) (September 12, 2016)
Credevo
Relevant Sections: Which EC? and CREC
(2) (Article) UPDATE 1: Thailand’s Clinical Trial Regulatory Scenario (THA-3) (February 14, 2017)
Credevo
Relevant Sections: Important Modifications in the New List
(3) (Article) UPDATE 2: Thailand’s Latest Approved IRB List (THA-4) (March 27, 2019)
Credevo
Relevant Sections: Important Updates in the New List and Saving Time…and Cost!
(4) (Document) 2018 List of Ethics Review Committees for Drug Clinical Trials (THA-9 - Thai) (2018)
Thai Food and Drug Administration, Ministry of Public Health
(5) (Document) 2020 List of Ethics Review Committees for Drug Clinical Trials (THA-12 - Thai) (2020)
Thai Food and Drug Administration, Ministry of Public Health
(6) (Form) Request for Acceptance or to Renew Acceptance for Authorization as an Ethics Committee to Review Clinical Research Drug Studies in Humans - Jor Thor Form EC-1 (THA-23 - Thai) (September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(7) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.27 and 3.3
(8) (Webpage) Central Research Ethics Committee (CREC) - About Us (THA-44 - Thai) (Current as of August 25, 2020)
Central Research Ethics Committee, National Research Council of Thailand
(9) (Webpage) CREC - Submission Form (SOP v.4.0) (THA-38 - Thai) (Current as of August 25, 2020)
Central Research Ethics Committee, National Research Council of Thailand
(10) (Webpage) Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH) - Roles and Responsibilities (THA-39 - Thai) (Current as of August 25, 2020)
Ministry of Public Health
Ethics Committee > Scope of Review
Last content review/update: August 26, 2020
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for Importing or Ordering Drugs in the Kingdom for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (Effective September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.2-1.3, 1.9-1.10, 1.12, 3, and Appendices 1-7, and 13
(3) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (Effective September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4
(4) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Announcement: 1; Notice: 4
(5) (Regulation) Notification of the Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 5-6
(6) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CT-DIPApp - English, unofficial version) (September 2009)
International Affairs and Investigational Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3 and 15
(7) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Chapter 2, 4, and 6
Summary

Overview

As stated in G-ResEthics, ECReg&Proc-2018, 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 Food and Drug Administration (Thai FDA) recognized ethics committees (ECs), relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. 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 now implementing THA-28. (See Informed Consent topic, and the subtopics of Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses, and Neonates; Prisoners; and Mentally Impaired for additional information about these populations).

In addition, per G-ResEthics, ECReg&Proc-2018, and THA-28, the 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 taking into account local or national laws, religions, traditions, and cultures. See G-ResEthics, ECReg&Proc-2018, and THA-28 for detailed ethical review guidelines. Also, see THA-13 for details specific to the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH).

Role in Clinical Trial Approval Process

As stated in TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugImprt2017, ECReg&Proc-2018, 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. Per TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the EC approval can be submitted to the Thai FDA after the rest of the application has been submitted for review. Therefore, the Thai FDA and EC may conduct their reviews in parallel.

TFDA-ClinDrugReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugLicenseReqs, and TFDA-ClinDrugImprt2017 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 Central Research Ethics Committee (CREC) website.

Additional Resources
(1) (Document) Guidelines and Procedures for Conducting Research on Human Subjects (THA-13 - Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Instruction for the Submission of a Study/Research Proposal to be Reviewed by The Ethic Review Committee for Research in Human Subject, Ministry of Public Health (p.63)
(2) (Document) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (THA-29) (Thai) (April 18, 1979)
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
(3) (Document) The Ethics of Research Related to Healthcare in Developing Countries (THA-11) (Thai) (April 24, 2002)
Nuffield Council on Bioethics
(4) (Form) Request for Acceptance or to Renew Acceptance for Authorization as an Ethics Committee to Review Clinical Research Drug Studies in Humans - Jor Thor Form EC-1 (THA-23 - Thai) (September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(5) (International Guidance) Declaration of Helsinki (THA-45) (Thai) (October 19, 2013)
World Medical Association
(6) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.27 and 3.3
(7) (International Guidance) International Ethical Guidelines for Biomedical Research Involving Human Subjects (THA-7) (Thai) (2002)
Council for International Organizations of Medical Sciences (CIOMS)
(8) (International Guidance) Nuremberg Code (THA-10) (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
Ethics Committee > Ethics Committee Fees
Last content review/update: August 26, 2020
Requirements
(1) (Regulation) Notification of the Foundation for Human Research Promotion in Thailand, Ministry of Public Health 005/2563 Regarding the Amendment of the Central Research Ethics Committee (CREC) Research Fees (CREC-ResFeeReqs - Thai) (Effective July 23, 2020)
Central Research Ethics Committee (CREC), National Research Council of Thailand
Summary

Overview

As set forth in the CREC-ResFeeReqs, 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 CREC-ResFeeReqs 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 CREC that require 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 CREC-ResFeeReqs 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 CREC that require local EC to re-approve the revised project fee determined by local institution

In addition, the CREC-ResFeeReqs 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 10th 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:

Ploi Pailin Young Chaiyaphum
E-mail: Ploypailin_Ncyp_CREC@hotmail.com

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

Additional Resources
(1) (Webpage) Central Research Ethics Committee (CREC) (THA-36 - Thai) (Current as of August 25, 2020)
Central Research Ethics Committee (CREC), National Research Council of Thailand
Relevant Sections: CREC Submission Fees
Ethics Committee > Authorizing Body
Last content review/update: August 26, 2020
Requirements
(1) (Legislation) Hospital Act, B.E. 2541 (HospitalAct - English, unofficial translation) (Thai) (March 15, 1998)
National Assembly
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for Importing or Ordering Drugs in the Kingdom for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (Effective September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4
(3) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.2-1.3, 1.10, 1.12, and Appendices 1-6, 13, and 15
(4) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (Effective September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4
(5) (Regulation) Notification of the Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 4-6, 9, and 11
Summary

Overview

As indicated in ECReg&Proc-2018, TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, and TFDA-ClinDrugProdReqs, 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. TFDA-ClinDrugReqs and ECReg&Proc-2018 specify that authorized ECs are responsible for reviewing and approving protocols for clinical research involving drugs to be imported into Thailand.

ECReg&Proc-2018 states that an EC may function as a committee under a government agency (e.g., the 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 CREC). Additionally, per ECReg&Proc-2018, 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

As per ECReg&Proc-2018, the 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 not later than 60 days before the expiration date.

Additional Resources
(1) (Form) Annual Report of Operations/Amendments for the Ethics Committee on Clinical Research Drug Studies in Humans - Jor Thor Form 3 (THA-21 - Thai) (September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(2) (Form) Request for Acceptance or to Renew Acceptance for Authorization as an Ethics Committee to Review Clinical Research Drug Studies in Humans - Jor Thor Form EC-1 (THA-23 - Thai) (September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(3) (Webpage) Central Research Ethics Committee (CREC) - About Us (THA-44 - Thai) (Current as of August 25, 2020)
Central Research Ethics Committee, National Research Council of Thailand
(4) (Webpage) Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH) - Roles and Responsibilities (THA-39 - Thai) (Current as of August 25, 2020)
Ministry of Public Health
Clinical Trial Lifecycle > Submission Process
Last content review/update: August 26, 2020
Requirements
(1) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (DrugAct - Thai) (Last Amended April 16, 2019) (Effective October 13, 2019)
National Assembly
Relevant Sections: Section 4
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for Importing or Ordering Drugs in the Kingdom for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (Effective September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface and 4
(3) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface 1.2-1.3, 1.5-1.6, 1.8, 1.10, 1.12, and Appendices 1-8, 11, 13, and 15
(4) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (Effective September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface and 3-4
(5) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Importing or Placing Medicines into the Kingdom of Thailand Without Registrations, No. 14 (BE 2532) (DrugImprtRules-1989 - Thai) (August 1, 1989)
Ministry of Public Health
Relevant Sections: Article 2 (Clause 3)
(6) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Taking or Placing Medicines into the Kingdom Without Requesting Registration of Drug Formulation, No. 2 (BE 2552) (DrugImprtRules-2009 - Thai) (Effective July 9, 2009)
Ministry of Public Health
Relevant Sections: Article 1 (Clauses 2 and 3)
(7) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Announcement: 1; Notice: Preface and 2-3
(8) (Regulation) Notification of the Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 5 and Form EC-1
(9) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CT-DIPApp - English, unofficial version) (September 2009)
International Affairs and Investigational Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3, 11, 12, 13, and 15
(10) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom for Clinical Research in the Case of Biomedical Drugs (FDA 1) (PubGuide-ClinBiolProdReqs - Thai) (Effective 29/01/2559 in Thai calendar; January 1, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(11) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom For Clinical Research In the Case of Medicines in Humans, Except for Biologic Drugs (FDA1) (PubGuide-ClinDrugReqs - Thai) (Effective 22/06/2559 in Thai calendar; June 6, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(12) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 6.1
Summary

Overview

In accordance with the DrugAct, TFDA-ClinDrugReqs, DrugImprtRules-1989, DrugImprtRules-2009, TFDA-ClinDrugLicenseReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the Thai Food and Drug Administration (Thai FDA) is responsible for overseeing the import of drugs for research purposes, and also uses this authority to indirectly regulate drug clinical trials in humans. As set forth in TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, ECReg&Proc-2018, and G-CT-DIPApp, the Thai FDA’s approval of a drug importation license is dependent upon obtaining proof of ethics committee (EC) approval to conduct the clinical trial by a Thai FDA-approved EC. Per TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the EC approval can be submitted to the Thai FDA after the rest of the application has been submitted for review. Therefore, the Thai FDA and EC may conduct their reviews in parallel.

Delivery Address for Clinical Trial Application

Per PubGuide-ClinDrugReqs, applications to be submitted for review and approval by the Thai FDA’s Bureau of Drug Control should be sent via the Thai FDA’s One Stop Service & Consultation Center (OSSC) (THA-35) at the address listed below. PubGuide-ClinDrugReqs also includes an address to track an application’s status and obtain the result of the application. THA-18 provides access to the clinical trial/drug import license application form, which is referred to as the Application Form for Permission to Import or Order Drugs into the Kingdom for Research Purposes (Nor Yor Mor 1) by the Thai FDA.

Applications should be submitted to:

One Stop Service & Consultation Center
Food and Drug Administration, 1st Floor
Ministry of Public Health
88/24 Tiwanon Road
Mueang District
Nonthaburi 11000
Thailand
Phone: +66 2 590-74124

To track status and get the result of the application:

Food and Drug Administration
Research Building 2, Floor 3, Room 315
Ministry of Public Health
88/24 Tiwanon Road
Mueang District
Nonthaburi 11000
Thailand
Phone: +66 2 590-7061

Assembly and Number of Copies

As per TFDA-ClinDrugReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, and THA-16, sponsors must submit two (2) original sets and one (1) copy of the completed Application for Permission to Import or Order Drugs into the Kingdom for Research Purposes (Nor Yor Mor 1) (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 TFDA-ClinDrugReqs). Per TFDA-ClinDrugReqs, 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 states that two (2) sets of the application package must be submitted to the Thai FDA.

According to THA-13, the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH) requires one (1) original and 20 copies of the protocol to be submitted in Thai, and one (1) copy be submitted in English for review purposes. The ECMOPH is one of the ECs approved by the Thai FDA to review and approve clinical trial protocols.

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).

THA-37 indicates that investigators applying for a new research project review by the Central Research Ethics Committee (CREC) should submit the following:

  • 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 (the Information sheet/Consent Form) (if required) (page number/version and date; noting in the event a participant has children; including documents specifying if participants are children and/or if assent form is required) (See THA-41 for details) (four (4) sets)
  • Investigator/co-investigator Curriculum vitaes (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 permits investigators to electronically submit applications 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 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.

Language Requirements

TFDA-ClinDrugReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, and G-CTDIPApp 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

According to THA-13, the ECMOPH requires the protocol to be submitted in Thai. One (1) copy may be provided in English for review. 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.

Additional Resources
(1) (Document) Guidelines and Procedures for Conducting Research on Human Subjects (THA-13 - Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Guidelines for the preparation of a research proposal submitted to the Ethical Review Committee for Research on Human Subjects, Ministry of Public Health (p.67)
(2) (Form) Notification of the Division of Drugs on Methods, Forms and Documents for Clinical Research Permission by Special Expressway Channel (THA-19 - Thai) (March 16, 2020)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(3) (Form) Notification of the Food and Drug Administration Regarding the Requirements for the Importation or Ordering of Drugs into the Kingdom for Clinical Research - Appendices (THA-18 - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Appendix 1: Application Form for Permission to Import or Order Drugs into the Kingdom for Research Purposes (Nor Yor Mor 1)
(4) (Form) Self-Submission Form for New Drug Registration Application Form (Except Biological Substances) (THA-17 - Thai) (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health
(5) (Form) Self-Submission Form for the Authorization, Production, Packaging, Importing or Ordering Placebos into the Kingdom (THA-24 - Thai) (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health
(6) (Form) Self-Submission Form for the Registration of a New Biological Drug Formula (Except Human Biological Vaccines) (THA-25 - Thai) (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health
(7) (Form) Self-Submission Form to Request Permission to Import or Order Drugs into the Kingdom for Clinical Trials (FDA 1) (THA-16 - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(8) (Webpage) Central Research Ethics Committee (CREC) - Online Submission System (THA-43 - English and Thai) (Current as of August 25, 2020)
Central Research Ethics Committee, National Research Council of Thailand
(9) (Webpage) Central Research Ethics Committee (CREC) - Submission Form (SOP v.4.0) (THA-37 - Thai) (Current as of August 25, 2020)
Central Research Ethics Committee, National Research Council of Thailand
Relevant Sections: CREC - Protocol Package Checklist Form
(10) (Webpage) Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH) - E-Submission Login (THA-40) (Thai) (Current as of August 25, 2020)
Institute of Medical Research and Technology Assessment, Ministry of Public Health
(11) (Webpage) Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH) - Frequently Asked Questions (THA-41 - Thai) (Current as of August 25, 2020)
Ministry of Public Health
Relevant Sections: 1. Introduce the Ethics Request System (E-Submission)
(12) (Webpage) Thai FDA - One Stop Service & Consultation Center (OSSC) (THA-35 - English and Thai) (Current as of August 25, 2020)
Thai Food and Drug Administration, Ministry of Public Health
Clinical Trial Lifecycle > Submission Content
Last content review/update: August 26, 2020
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for Importing or Ordering Drugs in the Kingdom for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (Effective September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1 and 4
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.1-1.4, 1.10, 1.12, 3, and Appendices 1-7, and 13
(3) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (Effective September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4
(4) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Importing or Placing Medicines into the Kingdom of Thailand Without Registrations, No. 14 (BE 2532) (DrugImprtRules-1989 - Thai) (August 1, 1989)
Ministry of Public Health
Relevant Sections: Article 2 (Clause 3)
(5) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Taking or Placing Medicines into the Kingdom Without Requesting Registration of Drug Formulation, No. 2 (BE 2552) (DrugImprtRules-2009 - Thai) (Effective July 9, 2009)
Ministry of Public Health
Relevant Sections: Article 1 (Clauses 2 and 3)
(6) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Announcement: 1; Notice: 4
(7) (Regulation) Notification of the Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 5
(8) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CT-DIPApp - English, unofficial version) (September 2009)
International Affairs and Investigational Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3, 12, 13, and 15
(9) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom for Clinical Research in the Case of Biomedical Drugs (FDA 1) (PubGuide-ClinBiolProdReqs - Thai) (Effective 29/01/2559 in Thai calendar; January 1, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(10) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom For Clinical Research In the Case of Medicines in Humans, Except for Biologic Drugs (FDA1) (PubGuide-ClinDrugReqs - Thai) (Effective 22/06/2559 in Thai calendar; June 6, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface and Appendices 1-5
(11) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 6
Summary

Overview

As set forth in TFDA-ClinDrugReqs, DrugImprtRules-1989, DrugImprtRules-2009, ECReg&Proc-2018, TFDA-ClinDrugLicenseReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, and G-CT-DIPApp, the Thai Food and Drug Administration (Thai FDA)’s approval of a drug importation license is dependent upon obtaining proof of ethics committee (EC) approval to conduct the clinical trial by a Thai FDA approved institutional EC.

Thai FDA Requirements

As per TFDA-ClinDrugReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, G-CT-DIPApp, and THA-16, sponsors must submit one (1) original set and two (2) copies of the following documents to the 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
  • Checklists and Attached Documents for Application Import License of Medicinal Drugs into Thailand for Clinical Trial according to Application for Permission to Import or Order Drugs into the Kingdom for Research Purposes (Nor Yor Mor 1) (THA-18)
  • Application for Permission to Import or Order Drugs into the Kingdom for Research Purposes (Nor Yor Mor 1) (THA-18)
  • Drug labels for every container (Thai or English)
  • Package inserts (for registered drugs)
  • Prescriptions (for registered drugs)
  • Investigator’s Brochure (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
  • EC approval from a Thai FDA-recognized institutionally-based EC and/or an independent EC (If not available, per TFDA-ClinDrugReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugLicenseReqs, and TFDA-ClinDrugImprt2017, 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

EC Requirements

As delineated in G-CT-DIPApp, applicants are required to submit the following documents to the Thai FDA for 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

THA-13 represents the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH)’s requirements and THA-37 represents the Central Research Ethics Committee (CREC) requirements; the ECMOPH and the CREC are two (2) of the ECs recognized by the Thai FDA to review and approve clinical research protocols.

Per THA-13, the ECMOPH requires investigators (applicants) to submit the following documentation for ethics approval:

  • One (1) original set and 20 copies in Thai of the protocol, 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
  • Result 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 PI required for each side
  • Material transfer agreement for transfer of blood or biomedical samples
  • References

According to THA-37, investigators applying for a new research project review by the 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 (the Information sheet/Consent Form) (if required) (page number/version and date; noting in the event a participant has children; including documents specifying if participants are children and/or if assent form is required) (See THA-37 for details) (four (4) sets)
  • Investigator/co-investigator Curriculum vitaes (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-13 and THA-37 for detailed ECMOPH and CREC submission requirements respectively.

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.

Clinical Protocol

As delineated in TFDA-ClinDrugReqs, 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 Clinical Trial Lifecycle topic, Safety Reporting subtopic 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
  • Investigational medicinal products (IMPs) to be used

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

G-CT-DIPApp also provides requirements to submit to the Thai FDA to be included in the protocol synopsis. 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 substance and details, 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.

Additional Resources
(1) (Document) Guidelines and Procedures for Conducting Research on Human Subjects (THA-13 - Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Guidelines for the preparation of a research proposal submitted to the Ethical Review Committee for Research on Human Subjects, Ministry of Public Health (p.67); Ethical Criteria: The Ethical Review Committee for Research in Human Subjects (Revised 2007) (p. 72)
(2) (Form) Notification of the Division of Drugs on Methods, Forms and Documents for Clinical Research Permission by Special Expressway Channel (THA-19 - Thai) (March 16, 2020)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(3) (Form) Notification of the Food and Drug Administration Regarding the Requirements for the Importation or Ordering of Drugs into the Kingdom for Clinical Research - Appendices (THA-18 - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Appendix 1: Application Form for Permission to Import or Order Drugs into the Kingdom for Research Purposes (Nor Yor Mor 1)
(4) (Form) Self-Submission Form for New Drug Registration Application Form (Except Biological Substances) (THA-17 - Thai) (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health
(5) (Form) Self-Submission Form for the Authorization, Production, Packaging, Importing or Ordering Placebos into the Kingdom (THA-24 - Thai) (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health
(6) (Form) Self-Submission Form for the Registration of a New Biological Drug Formula (Except Human Biological Vaccines) (THA-25 - Thai) (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health
(7) (Form) Self-Submission Form to Request Permission to Import or Order Drugs into the Kingdom for Clinical Trials (FDA 1) (THA-16 - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(8) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 6
(9) (International Guidance) Structure and Content of Clinical Study Reports (E3) (THA-27) (Step 4 Version) (November 1995)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(10) (Webpage) Central Research Ethics Committee (CREC) - Submission Form (SOP v.4.0) (THA-37 - Thai) (Current as of August 25, 2020)
Central Research Ethics Committee, National Research Council of Thailand
Relevant Sections: CREC - Protocol Package Checklist Form
Clinical Trial Lifecycle > Timeline of Review
Last content review/update: August 26, 2020
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for Importing or Ordering Drugs in the Kingdom for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (Effective September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1 and 4
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.2-1.3, 1.10, 1.12, and Appendices 1-7, and 13
(3) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (Effective September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4
(4) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Importing or Placing Medicines into the Kingdom of Thailand Without Registrations, No. 14 (BE 2532) (DrugImprtRules-1989 - Thai) (August 1, 1989)
Ministry of Public Health
Relevant Sections: Article 2 (Clause 3)
(5) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Taking or Placing Medicines into the Kingdom Without Requesting Registration of Drug Formulation, No. 2 (BE 2552) (DrugImprtRules-2009 - Thai) (Effective July 9, 2009)
Ministry of Public Health
Relevant Sections: Article 1 (Clauses 2 and 3)
(6) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1, 4, and 5
(7) (Regulation) Notification of the Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(8) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CT-DIPApp - English, unofficial version) (September 2009)
International Affairs and Investigational Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 2-3 and 15
(9) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom for Clinical Research in the Case of Biomedical Drugs (FDA 1) (PubGuide-ClinBiolProdReqs - Thai) (Effective 29/01/2559 in Thai calendar; January 1, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(10) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom For Clinical Research In the Case of Medicines in Humans, Except for Biologic Drugs (FDA1) (PubGuide-ClinDrugReqs - Thai) (Effective 22/06/2559 in Thai calendar; June 6, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(11) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 6
Summary

Overview

As set forth in TFDA-ClinDrugReqs, ECReg&Proc-2018, DrugImprtRules-1989, DrugImprtRules-2009, TFDA-ClinDrugLicenseReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugImprt2017, and G-CT-DIPApp, the Thai Food and Drug Administration (Thai FDA)’s approval of a drug importation license is dependent upon obtaining proof of ethics committee (EC) approval to conduct the clinical trial by a Thai FDA approved institutional EC. Per TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the EC approval can be submitted to the Thai FDA after the rest of the application has been submitted for review. Therefore, the Thai FDA and EC may conduct their reviews in parallel.

Thai FDA Approval

As delineated in PubGuide-ClinDrugReqs and PubGuide-ClinBiolProdReqs, 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-ClinBiolProdReqs, the Thai FDA review and approval process for biological medicines takes 60 days.

As set forth in TFDA-ClinDrugReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugLicenseReqs, and G-CT-DIPApp, the Thai FDA coordinates the review of applications submitted to obtain drug import licenses for clinical trial purposes. Per PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, 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 permit application for clinical trial purposes. If the reviewer finds the application package technically incorrect, then he/she will forward the application for rejection. If the reviewer finds the technical information to be incomplete, then he/she will request that the applicant or his/her attorney to clarify and/or submit additional documents/information. If the documentation or amended information is not submitted within five (5) working days, the Thai FDA will issue a rejection letter and return the package to the applicant. However, the applicant may resubmit a corrected package to the OSSC 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, TFDA-ClinDrugReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugLicenseReqs, and TFDA-ClinDrugImprt2017 further specifies that once the Thai FDA receives the EC approval documentation, the agency will complete its review within 15 days.

Applicants may submit import permit applications electronically to the OSSC via the e-submission link (THA-42).

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.

Additional Resources
(1) (Article) Medicinal Product Regulation and Product Liability in Thailand: Overview (THA-5) (January 1, 2020)
Practical Law
Relevant Sections: Clinical Trials
(2) (Document) Guidelines and Procedures for Conducting Research on Human Subjects (THA-13 - Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Instruction for the Submission of a Study/Research Proposal to be Reviewed by The Ethic Review Committee for Research in Human Subject, Ministry of Public Health (p.63); Guidelines for the preparation of a research proposal submitted to the Ethical Review Committee for Research on Human Subjects, Ministry of Public Health (p.67)
(3) (Form) Notification of the Division of Drugs on Methods, Forms and Documents for Clinical Research Permission by Special Expressway Channel (THA-19 - Thai) (March 16, 2020)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(4) (Form) Notification of the Food and Drug Administration Regarding the Requirements for the Importation or Ordering of Drugs into the Kingdom for Clinical Research - Appendices (THA-18 - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(5) (Form) Self-Submission Form for New Drug Registration Application Form (Except Biological Substances) (THA-17 - Thai) (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health
(6) (Form) Self-Submission Form for the Authorization, Production, Packaging, Importing or Ordering Placebos into the Kingdom (THA-24 - Thai) (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health
(7) (Form) Self-Submission Form for the Registration of a New Biological Drug Formula (Except Human Biological Vaccines) (THA-25 - Thai) (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health
(8) (Form) Self-Submission Form to Request Permission to Import or Order Drugs into the Kingdom for Clinical Trials (FDA 1) (THA-16 - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(9) (Webpage) OSSC - E-submissions (THA-42 - Thai) (Current as of August 25, 2020)
Thai Food and Drug Administration, Ministry of Public Health
(10) (Webpage) Thai FDA - One Stop Service & Consultation Center (OSSC) (THA-35 - English and Thai) (Current as of August 25, 2020)
Thai Food and Drug Administration, Ministry of Public Health
Clinical Trial Lifecycle > Trial Initiation
Last content review/update: August 26, 2020
Requirements
(1) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (DrugAct - Thai) (Last Amended April 16, 2019) (Effective October 13, 2019)
National Assembly
Relevant Sections: Section 4, Chapter I (10), Chapter II (12), and Chapter V (46)
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for Importing or Ordering Drugs in the Kingdom for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (Effective September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4
(3) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 1.2-1.3, 1.10, 1.12, and Appendices 1-7, 11, and 13
(4) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (Effective September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 3-4, and 6
(5) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Importing or Placing Medicines into the Kingdom of Thailand Without Registrations, No. 14 (BE 2532) (DrugImprtRules-1989 - Thai) (August 1, 1989)
Ministry of Public Health
Relevant Sections: Article 2 (Clause 3)
(6) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Taking or Placing Medicines into the Kingdom Without Requesting Registration of Drug Formulation, No. 2 (BE 2552) (DrugImprtRules-2009 - Thai) (Effective July 9, 2009)
Ministry of Public Health
Relevant Sections: Article 1 (Clauses 2 and 3)
(7) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Announcement (1); Notice: Preface and 2-5
(8) (Regulation) Notification of the Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4-5 and 9-10
(9) (Guidance) Guidance for Adverse Event Report from “Achieving Guidance in Clinical Trial Safety Information Among Stakeholder” Forum for Ethical Review Committee in Thailand (FERCIT) (G-AEReptReqs - Thai and English) (June 2011)
Forum for Ethical Review Committees in Thailand
Relevant Sections: Descriptions and Definitions
(10) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CT-DIPApp - English, unofficial version) (September 2009)
International Affairs and Investigational Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1-3 and 15
(11) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom for Clinical Research in the Case of Biomedical Drugs (FDA 1) (PubGuide-ClinBiolProdReqs - Thai) (Effective 29/01/2559 in Thai calendar; January 1, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(12) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom For Clinical Research In the Case of Medicines in Humans, Except for Biologic Drugs (FDA1) (PubGuide-ClinDrugReqs - Thai) (Effective 22/06/2559 in Thai calendar; June 6, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(13) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 5 (6)
Summary

Overview

In accordance with TFDA-ClinDrugReqs, ECReg&Proc-2018, DrugImprtRules-1989, DrugImprtRules-2009, TFDA-ClinDrugLicenseReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugImprt2017, and G-CT-DIPApp, 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. See the Ethics Committee topic, Ethics Committee subtopic for detailed institutional EC requirements.

According to TFDA-ClinDrugReqs, ECReg&Proc-2018, DrugImprtRules-1989, DrugImprtRules-2009, TFDA-ClinDrugLicenseReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugImprt2017, DrugAct, and G-CT-DIPApp, 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 TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the import license will expire in four (4) years from the date of issuance. TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017 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 Investigational Products topic, Manufacturing & Import subtopic for additional information).

G-ResEthics and THA-5 specify that all investigators must also possess appropriate qualifications, training, and experience. 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.

See THA-13 for requirements specifically related to studies approved by the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH).

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.

EC Confirmation of Review and Approval

As per TFDA-ClinDrugReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugImprt2017 and ECReg&Proc-2018, clinical trials require institutional level EC approval for each trial site from an EC recognized by the Thai FDA. As delineated in ECReg&Proc-2018 and G-CT-DIPApp, Thai FDA recognized ECs are responsible for reviewing and approving clinical research involving drugs to be imported for use in Thailand. (See Ethics Committee topic, Scope of Review subtopic for additional details on the EC review process).

Thailand Clinical Trials Registry

The TFDA-ClinDrugReqs 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 TFDA-ClinDrugReqs 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.

Data and Safety Monitoring Board

Although G-AEReptReqs and the G-ResEthics do not mandate establishing a Data Safety Monitoring Board (DSMB), it is encouraged. Per THA-28, a DSMB may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Additional Resources
(1) (Article) Medicinal Product Regulation and Product Liability in Thailand: Overview (THA-5) (January 1, 2020)
Practical Law
Relevant Sections: Clinical Trials
(2) (Document) Guidelines and Procedures for Conducting Research on Human Subjects (THA-13 - Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Ethical Criteria: The Ethical Review Committee for Research in Human Subjects (p. 72)
(3) (Form) Notification of the Food and Drug Administration Regarding the Requirements for the Importation or Ordering of Drugs into the Kingdom for Clinical Research - Appendices (THA-18 - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(4) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.25, 2.8, 4.1, 5.1, and 5.5
(5) (Webpage) Thai Clinical Trials Registry (TCTR) (THA-31) (Current as of August 25, 2020)
Medical Research Network (MedResNet), Medical Research Foundation
Clinical Trial Lifecycle > Safety Reporting
Last content review/update: August 26, 2020
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for Importing or Ordering Drugs in the Kingdom for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (Effective September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4.5 and Appendix 20
(3) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (Effective September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 2
(4) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3.3
(5) (Guidance) Guidance for Adverse Event Report from “Achieving Guidance in Clinical Trial Safety Information Among Stakeholder” Forum for Ethical Review Committee in Thailand (FERCIT) (G-AEReptReqs - Thai and English) (June 2011)
Forum for Ethical Review Committees in Thailand
Relevant Sections: Descriptions and Definitions, 1, 2, 4, Appendix 1, Appendix 2, Appendix 3, and Appendix 4
(6) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CT-DIPApp - English, unofficial version) (September 2009)
International Affairs and Investigational Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 16.3
(7) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 5 (17)
Summary

Overview

In accordance with TFDA-ClinDrugReqs, 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 now 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.

Reporting Requirements for AEs/ADRs

As delineated in TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugImprt2017, G-CT-DIPApp, and THA-28, sponsors who are permitted to import or order drugs into Thailand for research 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. TFDA-ClinDrugReqs 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 TFDA-ClinDrugReqs, 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. Refer to THA-22 for the Thailand Health Product Adverse Event Report Form
  • 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

Furthermore, per TFDA-ClinDrugReqs, annual and end of study safety reports must be provided to the Thai FDA’s Bureau of Drug Control. 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 TFDA-ClinDrugReqs for an example of the reporting form.

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-38 respectively.

Sponsor Responsibilities

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.

THA-28 also 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.

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-38 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:

Mailing Address:

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

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

Pursuant to TFDA-ClinDrugReqs, 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.

Data Safety Monitoring Board

Although G-ResEthics and G-AEReptReqs do not appear to mandate establishing a Data Safety Monitoring Board (DSMB), it is encouraged. Per THA-28, a DSMB may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Additional Resources
(1) (Document) Comparative Analysis: Pharmacovigilance Systems in Five Asian Countries (THA-8) (September 2013)
Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program and US Agency for International Development (USAID)
Relevant Sections: Signal Generation and Data Management - Existence of a Form for Reporting Suspected ADRs, and Annex F and G
(2) (Document) Guidelines and Procedures for Conducting Research on Human Subjects (THA-13 - Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Ethical Criteria: The Ethical Review Committee for Research in Human Subjects (Revised 2007) (p. 72); Additional Resolution of the Committee (2005) (p. 76)
(3) (Form) Additional investigation Guidelines (HPVC Form - 13) (THA-15 - Thai) (Date Unavailable)
Health Product Vigilance Center (HPVC), Food and Drug Administration, Ministry of Public Health
(4) (Form) CIOMS Form I (THA-20) (Date Unavailable)
Council for International Organizations of Medical Sciences
(5) (Form) Investigation of Adverse Events After Receiving a Suspected Product (HPVC Form - 12) (THA-14 - Thai and English) (Date Unavailable)
Health Product Vigilance Center (HPVC), Food and Drug Administration, Ministry of Public Health
(6) (Form) Thailand Health Product Adverse Event Report Form (HPVC Form-1 - THA-22) (Form and Instructions - Thai) (Date Unavailable)
Health Product Vigilance Center (HPVC), Food and Drug Administration, Ministry of Public Health
(7) (International Guidance) Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A) (THA-26) (Step 4 Version) (October 27, 1994)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: II
(8) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.1-1.2, 1.50, 1.60, 5.5, and 5.17
(9) (Webpage) CREC - Submission Form (SOP v.4.0) (THA-38 - Thai) (Current as of August 25, 2020)
Central Research Ethics Committee, National Research Council of Thailand
Relevant Sections: CREC 11 / v.4.0 Review of Adverse Event Reports
(10) (Webpage) Health Product Vigilance Center (HPVC) (THA-30 - Thai) (Current as of August 25, 2020)
Health Product Vigilance Center (HPVC), Food and Drug Administration, Ministry of Public Health
Clinical Trial Lifecycle > Progress Reporting
Last content review/update: August 26, 2020
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for Importing or Ordering Drugs in the Kingdom for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (Effective September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4.1, 4.3 and Appendices 14-15 and 19
(3) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (Effective September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3
(4) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3.3
(5) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 6.6
Summary

Overview

Pursuant to G-ResEthics, the investigator(s) is responsible for submitting progress reports on the status of the trial and for submitting a final study report to the ethics committee (EC). The International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28) also indicates that investigator(s) should submit progress reports to the EC. Per an in-country subject matter expert, Thailand is now implementing THA-28. TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017 state that the sponsor is required to submit annual progress reports to the Thai Food and Drug Administration (Thai FDA).

Interim/Progress Reports

As delineated in G-ResEthics, the investigator(s) must submit progress reports to the 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.

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.

In addition, according to TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the sponsor must submit a study progress report annually to the Thai FDA between October 1 and 31 every year until the study ends. Per TFDA-ClinDrugReqs, 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 TFDA-ClinDrugReqs and TFDA-ClinDrugImprt2017, in the event of early termination of the research study, the sponsor must submit a summary report (Appendix 19 of TFDA-ClinDrugReqs) 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-38 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.

Per an in-country subject matter expert, because each EC has its own requirements, it is recommended that the individual ECs be contacted to confirm their specific requirements.

Additional Resources
(1) (Document) Guidelines and Procedures for Conducting Research on Human Subjects (THA-13 - Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Ethical Review Committee for Research in Human Subjects Ministry of Public Health (Revised 2007) (p. 72); Additional Resolution of the Committee (2005) (p. 76); Additional Resolution of the Committee (2006) (p. 80)
(2) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.10
(3) (Webpage) CREC - Submission Form (SOP v.4.0) (THA-38 - Thai) (Current as of August 25, 2020)
Central Research Ethics Committee, National Research Council of Thailand
Relevant Sections: CREC 12 / v.4.0 Review of Close Study Reports; CREC 13 / v.4.0 Management of Study Termination Report
Sponsorship > Definition of Sponsor
Last content review/update: August 26, 2020
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Appendices 1, 3, and 7-8
(2) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 5
Summary

Overview

In accordance with G-ResEthics, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28), a sponsor is defined as an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. Per an in-country subject matter expert, Thailand is now 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), which is one (1) of the ethics committees approved by the Thai Food and Drug Administration (Thai FDA) to approve clinical research protocols, requires that the sponsor and/or CRO be legally registered in Thailand. See THA-13 for more details.

Per TFDA-ClinDrugReqs, the sponsor is also referred to as the applicant or importer.

Additional Resources
(1) (Document) Guidelines and Procedures for Conducting Research on Human Subjects (THA-13 - Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Additional Resolution of the Committee (2005) (p. 76) and Additional Resolution of the Committee (2006) (p. 80)
(2) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.20, 1.53-1.54, and 5.2
Sponsorship > Trial Authorization
Last content review/update: August 26, 2020
Requirements
(1) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (DrugAct - Thai) (Last Amended April 16, 2019) (Effective October 13, 2019)
National Assembly
Relevant Sections: Section 4, Chapter I (10), Chapter II (12), and Chapter V (46)
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for Importing or Ordering Drugs in the Kingdom for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (Effective September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3-5
(3) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 1.1-1.4, 1.10, 1.12, and Appendices 1-4 and 13
(4) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (Effective September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface and 3-4
(5) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Importing or Placing Medicines into the Kingdom of Thailand Without Registrations, No. 14 (BE 2532) (DrugImprtRules-1989 - Thai) (August 1, 1989)
Ministry of Public Health
Relevant Sections: Article 2 (Clause 3)
(6) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Taking or Placing Medicines into the Kingdom Without Requesting Registration of Drug Formulation, No. 2 (BE 2552) (DrugImprtRules-2009 - Thai) (Effective July 9, 2009)
Ministry of Public Health
Relevant Sections: Article 1 (Clauses 2 and 3)
(7) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Notice: Preface, 2-3, and 5
(8) (Regulation) Notification of the Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 4-5
(9) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CT-DIPApp - English, unofficial version) (September 2009)
International Affairs and Investigational Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3 and 15
(10) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom for Clinical Research in the Case of Biomedical Drugs (FDA 1) (PubGuide-ClinBiolProdReqs - Thai) (Effective 29/01/2559 in Thai calendar; January 1, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(11) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom For Clinical Research In the Case of Medicines in Humans, Except for Biologic Drugs (FDA1) (PubGuide-ClinDrugReqs - Thai) (Effective 22/06/2559 in Thai calendar; June 6, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
Summary

Overview

In accordance with TFDA-ClinDrugReqs, ECReg&Proc-2018, DrugImprtRules-1989, DrugImprtRules-2009, TFDA-ClinDrugLicenseReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, 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 per the DrugAct, TFDA-ClinDrugReqs, DrugImprtRules-1989, DrugImprtRules-2009, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, and TFDA-ClinDrugImprt2017, the Thai FDA is the authority responsible for controlling the import of drugs for research purposes, and also uses this authority to indirectly regulate drug clinical trials in humans. Per TFDA-ClinDrugReqs, the sponsor is also referred to as the applicant or importer.

To complete the application package, the sponsor or his/her CRO must use the Thai FDA’s Application for Permission to Import or Order Drugs into the Kingdom for Research Purposes (Nor Yor Mor 1) (see THA-18). In addition to the completed application, the sponsor or the CRO must also provide the ethics committee (EC) approval letter, clinical protocol, participant information sheet, informed consent certificate, a certificate of analysis, and other documentation covered in the Clinical Trial Lifecycle topic, Submission Content subtopic.

Additional Resources
(1) (Article) Medicinal Product Regulation and Product Liability in Thailand: Overview (THA-5) (January 1, 2020)
Practical Law
Relevant Sections: Clinical Trials
(2) (Form) Notification of the Food and Drug Administration Regarding the Requirements for the Importation or Ordering of Drugs into the Kingdom for Clinical Research - Appendices (THA-18 - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Appendix 1: Application Form for Permission to Import or Order Drugs into the Kingdom for Research Purposes (Nor Yor Mor 1)
Sponsorship > Insurance
Last content review/update: August 26, 2020
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.10 and Appendices 3 and 7
(2) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 5 (8)
Summary

Overview

TFDA-ClinDrugReqs 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.

See the Sponsorship topic, Compensation subtopic and Informed Consent topic, Compensation Disclosure subtopic for specific details related to sponsorship compensation obligations.

Additional Resources
No additional resources
Sponsorship > Compensation
Last content review/update: August 26, 2020
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.8 and Appendices 3
(2) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CT-DIPApp - English, unofficial version) (September 2009)
International Affairs and Investigational Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 11
(3) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 3.2 and Annex 5 (8)
Summary

Overview

As specified in TFDA-ClinDrugReqs, 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 now implementing THA-28.

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.

Additional Resources
(1) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8
Sponsorship > Quality, Data & Records Management
Last content review/update: August 26, 2020
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for Importing or Ordering Drugs in the Kingdom for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (Effective September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.7, 1.10, 4.3-4.4, 4.6, and Appendix 19
(3) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (Effective September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3
(4) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Notice: 3
(5) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CT-DIPApp - English, unofficial version) (September 2009)
International Affairs and Investigational Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 16.2
(6) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 5 (1, 5, 6, 19, 21, and 23)
Summary

Overview

As stated in TFDA-ClinDrugReqs 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's Guideline for Good Clinical Practice E6(R2) (THA-28). Per an in-country subject matter expert, Thailand is now 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
  • Permit 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)

TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017 state that the trial must be conducted in accordance with the Good Clinical Practice (GCP) and Good Laboratory Practice principles (GLP).

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 SOPs 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. TFDA-ClinDrugReqs 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.

Record 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.

Audit 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 FDA. No specific timeframe is provided for the audit process.

Per TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, 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.

TFDA-ClinDrugReqs 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 permit (Nor Yor Mor 1) (THA-18) 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 TFDA-ClinDrugReqs.) As stated in TFDA-ClinDrugReqs and TFDA-ClinDrugImprt2017 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 TFDA-ClinDrugReqs contains a sample notification form required to be completed when terminating a research project).

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 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
Additional Resources
(1) (Form) Notification of the Food and Drug Administration Regarding the Requirements for the Importation or Ordering of Drugs into the Kingdom for Clinical Research - Appendices (THA-18 - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Appendix 1: Application Form for Permission to Import or Order Drugs into the Kingdom for Research Purposes (Nor Yor Mor 1)
(2) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.65, 4.9, 4.12, 5.0, 5.1, 5.5, 5.6, 5.18, 5.19, 5.21, 5.23, 6.10, and 8
Sponsorship > Site/Investigator Selection
Last content review/update: August 26, 2020
Requirements
(1) (Guidance) Guidance for Adverse Event Report from “Achieving Guidance in Clinical Trial Safety Information Among Stakeholder” Forum for Ethical Review Committee in Thailand (FERCIT) (G-AEReptReqs - Thai and English) (June 2011)
Forum for Ethical Review Committees in Thailand
Relevant Sections: Descriptions and Definitions, Appendix 3
(2) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 5 (5, 6 and 7)
Summary

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. 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 seem to encourage the establishment of a Data Safety Monitoring Board (DSMB).

Additional Resources
(1) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.25, 4.1, 5.1, 5.5, and 5.7
Informed Consent > Documentation Requirements
Last content review/update: August 26, 2020
Requirements
(1) (Legislation) National Health Act B.E. 2550 (NatHlthAct - English, unofficial translation) (Thai) (March 3, 2007)
National Assembly
Relevant Sections: Section 9
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.8 and Appendix 3
(3) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CT-DIPApp - English, unofficial version) (September 2009)
International Affairs and Investigational Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 11
(4) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 2.2, 3.1, 3.2, and 3.3
Summary

Overview

In all Thai clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in TFDA-ClinDrugReqs, 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 now implementing THA-28. As per TFDA-ClinDrugReqs, 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 permit application to conduct a clinical trial. (See the Informed Consent topic, Required Elements subtopic 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.)

TFDA-ClinDrugReqs, THA-28, the NatHlthAct, and G-ResEthics 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.

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.

Language Requirements

As stated in TFDA-ClinDrugReqs, 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.

Documentation Copies

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.

Additional Resources
(1) (Document) Guidelines and Procedures for Conducting Research on Human Subjects (THA-13 - Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Information Sheet (p.70)
(2) (Document) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (THA-29) (Thai) (April 18, 1979)
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
(3) (Document) The Ethics of Research Related to Healthcare in Developing Countries (THA-11) (Thai) (April 24, 2002)
Nuffield Council on Bioethics
(4) (International Guidance) Declaration of Helsinki (THA-45) (Thai) (October 19, 2013)
World Medical Association
(5) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.27-1.28, 2.9, 3.1, 4.8, and 8.2-8.3
(6) (International Guidance) International Ethical Guidelines for Biomedical Research Involving Human Subjects (THA-7) (Thai) (2002)
Council for International Organizations of Medical Sciences (CIOMS)
(7) (International Guidance) Nuremberg Code (THA-10) (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
Informed Consent > Required Elements
Last content review/update: August 26, 2020
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.8 and Appendix 3
(2) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CT-DIPApp - English, unofficial version) (September 2009)
International Affairs and Investigational Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 11
(3) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 3.1.1 and 3.2
Summary

Overview

As delineated in TFDA-ClinDrugReqs and G-ResEthics, prior to beginning a clinical trial, the sponsor or his/her contract research organization (CRO) is required to obtain ethics committee (EC) approval from the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH) and/or the institutional ECs for the written informed consent form (ICF) and any other information being provided to the research participant and/or his/her legal representative(s) or guardian(s). The International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28) also indicates that the ICF and other consent related documentation must be approved by the institutional EC. Per an in-country subject matter expert, Thailand is now implementing THA-28.

No Coercion

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.

ICF Required Elements

Based on TFDA-ClinDrugReqs, G-ResEthics, G-CT-DIPApp, and THA-28, the 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 ECs, 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 ECMOPH, which is one (1) of the institutional ECs approved by the Thai FDA.

See the Informed Consent topic, Compensation Disclosure and Vulnerable Populations subtopics and the Specimens topic, Consent for Specimens subtopic for further information.

Additional Resources
(1) (Document) Guidelines and Procedures for Conducting Research on Human Subjects (THA-13 - Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Information Sheet (p.70)
(2) (Document) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (THA-29) (Thai) (April 18, 1979)
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
(3) (Document) The Ethics of Research Related to Healthcare in Developing Countries (THA-11) (Thai) (April 24, 2002)
Nuffield Council on Bioethics
(4) (International Guidance) Declaration of Helsinki (THA-45) (Thai) (October 19, 2013)
World Medical Association
(5) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.27, 2.6, 3.1, 4.8, and 8.2-8.3
(6) (International Guidance) International Ethical Guidelines for Biomedical Research Involving Human Subjects (THA-7) (Thai) (2002)
Council for International Organizations of Medical Sciences (CIOMS)
(7) (International Guidance) Nuremberg Code (THA-10) (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
Informed Consent > Compensation Disclosure
Last content review/update: August 26, 2020
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.8 and Appendix 3
(2) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CT-DIPApp - English, unofficial version) (September 2009)
International Affairs and Investigational Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 11
(3) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 3.1.1, 3.1.2, and Annex 5 (8)
Summary

Overview

In accordance with TFDA-ClinDrugReqs, G-ResEthics, G-CT-DIPApp, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28), the informed consent form (ICF) should contain a statement describing the compensation or medical treatment a participant can receive for participating in a clinical trial. Per an in-country subject matter expert, Thailand is now implementing THA-28. (See the Informed Consent topic, Required Elements subtopic for additional details on what should be included in the ICF, and the Sponsorship topic, Compensation subtopic for information on sponsor requirements.)

Compensation for Participation in Research

TFDA-ClinDrugReqs and G-CT-DIPApp state that participants should be informed of compensation (if any) to be provided for participating in the research. 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. In addition, as specified in the G-ResEthics and THA-28, the ICF should also inform all trial participants of any types of expenses that they may incur as a result of participation. THA-28 also indicates that the ICF should state if any compensation will be provided for participants involved in the research study.

Compensation for Injury

As stated in TFDA-ClinDrugReqs, G-ResEthics, G-CT-DIPApp, and THA-28, the ICF should contain a statement advising the participant and describing the compensation and medical treatment available in the event of any trial-related injury in a clinical trial.

Additional Resources
(1) (Document) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (THA-29) (Thai) (April 18, 1979)
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
(2) (Document) The Ethics of Research Related to Healthcare in Developing Countries (THA-11) (Thai) (April 24, 2002)
Nuffield Council on Bioethics
(3) (International Guidance) Declaration of Helsinki (THA-45) (Thai) (October 19, 2013)
World Medical Association
(4) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8
(5) (International Guidance) International Ethical Guidelines for Biomedical Research Involving Human Subjects (THA-7) (Thai) (2002)
Council for International Organizations of Medical Sciences (CIOMS)
(6) (International Guidance) Nuremberg Code (THA-10) (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
Informed Consent > Participant Rights
Last content review/update: August 26, 2020
Requirements
(1) (Legislation) National Health Act B.E. 2550 (NatHlthAct - English, unofficial translation) (Thai) (March 3, 2007)
National Assembly
Relevant Sections: Section 9
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.8 and Appendix 3
(3) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CT-DIPApp - English, unofficial version) (September 2009)
International Affairs and Investigational Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 11
(4) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 2.2, 3.1, 3.2, 3.3, and 4.1
Summary

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. Per an in-country subject matter expert, Thailand is now implementing THA-28. TFDA-ClinDrugReqs, 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 TFDA-ClinDrugReqs, 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 TFDA-ClinDrugReqs, 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 TFDA-ClinDrugReqs, 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.

The Right of Inquiry/Appeal

TFDA-ClinDrugReqs, G-ResEthics, G-CT-DIPApp, and THA-28 states 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 Informed Consent topic, and the subtopics of Required Elements and Vulnerable Populations for additional information regarding requirements for participant rights.)

Additional Resources
(1) (Document) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (THA-29) (Thai) (April 18, 1979)
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
(2) (Document) The Ethics of Research Related to Healthcare in Developing Countries (THA-11) (Thai) (April 24, 2002)
Nuffield Council on Bioethics
(3) (International Guidance) Declaration of Helsinki (THA-45) (Thai) (October 19, 2013)
World Medical Association
(4) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.28, 4.8, and 8.2
(5) (International Guidance) International Ethical Guidelines for Biomedical Research Involving Human Subjects (THA-7) (Thai) (2002)
Council for International Organizations of Medical Sciences (CIOMS)
(6) (International Guidance) Nuremberg Code (THA-10) (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
Informed Consent > Special Circumstances/Emergencies
Last content review/update: August 26, 2020
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 2.2.3, 3.3, and 6.4
Summary

Overview

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 now implementing THA-28. G-ResEthics also makes provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by special circumstances.

Medical Emergencies

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.

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.

Additional Resources
(1) (Document) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (THA-29) (Thai) (April 18, 1979)
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
(2) (Document) The Ethics of Research Related to Healthcare in Developing Countries (THA-11) (Thai) (April 24, 2002)
Nuffield Council on Bioethics
(3) (International Guidance) Declaration of Helsinki (THA-45) (Thai) (October 19, 2013)
World Medical Association
(4) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.61, 3.17, and 4.8.15
(5) (International Guidance) International Ethical Guidelines for Biomedical Research Involving Human Subjects (THA-7) (Thai) (2002)
Council for International Organizations of Medical Sciences (CIOMS)
(6) (International Guidance) Nuremberg Code (THA-10) (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
Informed Consent > Vulnerable Populations
Last content review/update: August 26, 2020
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 2.2.2 and 3.4
Summary

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. 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. Per an in-country subject matter expert, Thailand is now implementing THA-28. 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 Informed Consent topic, and the subtopics of Children/Minors; Pregnant Women, Fetuses & Neonates; and Mentally Impaired for additional information about these vulnerable populations.

Additional Resources
(1) (Document) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (THA-29) (Thai) (April 18, 1979)
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
(2) (Document) The Ethics of Research Related to Healthcare in Developing Countries (THA-11) (Thai) (April 24, 2002)
Nuffield Council on Bioethics
(3) (International Guidance) Declaration of Helsinki (THA-45) (Thai) (October 19, 2013)
World Medical Association
(4) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.61
(5) (International Guidance) International Ethical Guidelines for Biomedical Research Involving Human Subjects (THA-7) (Thai) (2002)
Council for International Organizations of Medical Sciences (CIOMS)
(6) (International Guidance) Nuremberg Code (THA-10) (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
Informed Consent > Children/Minors
Last content review/update: August 26, 2020
Requirements
(1) (Legislation) Thailand Civil and Commercial Code (B.E. 2468) (ThaiCode - English, unofficial version) (Thai) (January 1, 1925)
National Assembly
Relevant Sections: Part II (Sections 19 and 20)
(2) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 2.2.2 and 3.4
Summary

Overview

According to the ThaiCode a minor is someone under 20 years of age or married. 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 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. See THA-13 for more details, as well as information regarding age of assent. Per THA-37, according to the Central Research Ethics Committee (CREC), a minor is someone under 18 years of age, and children aged 13 years and older should sign an assent form. The ECMOPH and the CREC are both ECs recognized by the Thai Food and Drug Administration (Thai FDA).

Additional Resources
(1) (Document) Guidelines and Procedures for Conducting Research on Human Subjects (THA-13 - Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Additional Resolution of the Committee (2006) (p.77)
(2) (Document) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (THA-29) (Thai) (April 18, 1979)
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
(3) (Document) The Ethics of Research Related to Healthcare in Developing Countries (THA-11) (Thai) (April 24, 2002)
Nuffield Council on Bioethics
(4) (International Guidance) Declaration of Helsinki (THA-45) (Thai) (October 19, 2013)
World Medical Association
(5) (International Guidance) International Ethical Guidelines for Biomedical Research Involving Human Subjects (THA-7) (Thai) (2002)
Council for International Organizations of Medical Sciences (CIOMS)
(6) (International Guidance) Nuremberg Code (THA-10) (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
(7) (Webpage) Central Research Ethics Committee (CREC) - Submission Form (SOP v.4.0) (THA-37 - Thai) (Current as of August 25, 2020)
Central Research Ethics Committee, National Research Council of Thailand
Relevant Sections: CREC - Protocol Package Checklist Form
Informed Consent > Pregnant Women, Fetuses & Neonates
Last content review/update: August 26, 2020
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 2.2 and 3.4
Summary

Overview

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.

Additional Resources
(1) (Document) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (THA-29) (Thai) (April 18, 1979)
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
(2) (Document) The Ethics of Research Related to Healthcare in Developing Countries (THA-11) (Thai) (April 24, 2002)
Nuffield Council on Bioethics
(3) (International Guidance) Declaration of Helsinki (THA-45) (Thai) (October 19, 2013)
World Medical Association
(4) (International Guidance) International Ethical Guidelines for Biomedical Research Involving Human Subjects (THA-7) (Thai) (2002)
Council for International Organizations of Medical Sciences (CIOMS)
(5) (International Guidance) Nuremberg Code (THA-10) (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
Informed Consent > Prisoners
Last content review/update: August 26, 2020
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 2.2, 3.2, and 3.4
Summary

Overview

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.

Additional Resources
(1) (Document) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (THA-29) (Thai) (April 18, 1979)
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
(2) (Document) The Ethics of Research Related to Healthcare in Developing Countries (THA-11) (Thai) (April 24, 2002)
Nuffield Council on Bioethics
(3) (International Guidance) Declaration of Helsinki (THA-45) (Thai) (October 19, 2013)
World Medical Association
(4) (International Guidance) International Ethical Guidelines for Biomedical Research Involving Human Subjects (THA-7) (Thai) (2002)
Council for International Organizations of Medical Sciences (CIOMS)
(5) (International Guidance) Nuremberg Code (THA-10) (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
Informed Consent > Mentally Impaired
Last content review/update: August 26, 2020
Requirements
(1) (Legislation) Mental Health Act B.E. 2551 (MentalHlthAct - Thai) (Effective February 21, 2008)
National Assembly
Relevant Sections: Sections 3, 17, and 20-22
(2) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 3.4.5
Summary

Overview

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.

Additional Resources
(1) (Document) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (THA-29) (Thai) (April 18, 1979)
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
(2) (Document) The Ethics of Research Related to Healthcare in Developing Countries (THA-11) (Thai) (April 24, 2002)
Nuffield Council on Bioethics
(3) (International Guidance) Declaration of Helsinki (THA-45) (Thai) (October 19, 2013)
World Medical Association
(4) (International Guidance) International Ethical Guidelines for Biomedical Research Involving Human Subjects (THA-7) (Thai) (2002)
Council for International Organizations of Medical Sciences (CIOMS)
(5) (International Guidance) Nuremberg Code (THA-10) (Thai) (1947)
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2
Investigational Products > Definition of Investigational Product
Last content review/update: August 26, 2020
Requirements
(1) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (DrugAct - Thai) (Last Amended April 16, 2019) (Effective October 13, 2019)
National Assembly
Relevant Sections: General Provisions (4)
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Appendix 1
(3) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 7.1 and Annex 5
Summary

Overview

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 now 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

According to TFDA-ClinDrugReqs, drugs used in clinical trials may be modern drugs or traditional drugs, which are defined by the DrugAct as follows:

  • “Modern drug” means a drug intended for use in the practice of modern medicine or the cure of an animal disease
  • “Traditional drug” means a drug intended for use in the practice of traditional medicine or the cure of an animal disease which appears in a pharmacopoeia of traditional drugs notified by the Minister, or a drug notified by the Minister as a traditional drug, or a drug with a formula that has been registered as a traditional drug
Additional Resources
(1) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.33
Investigational Products > Manufacturing & Import
Last content review/update: August 26, 2020
Requirements
(1) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (DrugAct - Thai) (Last Amended April 16, 2019) (Effective October 13, 2019)
National Assembly
Relevant Sections: Chapter I (10), Chapter II (12), Chapter III (25 and 27), and Chapter V (46)
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for Importing or Ordering Drugs in the Kingdom for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (Effective September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 2-3, 5, and 10
(3) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 1.1-1.4, 1.9, 1.11, 1.13, and Appendices 1-4, 7-11, and 18
(4) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (Effective September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 2-3, 5-6, and 10
(5) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Importing or Placing Medicines into the Kingdom of Thailand Without Registrations, No. 14 (BE 2532) (DrugImprtRules-1989 - Thai) (August 1, 1989)
Ministry of Public Health
(6) (Regulation) Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for Taking or Placing Medicines into the Kingdom Without Requesting Registration of Drug Formulation, No. 2 (BE 2552) (DrugImprtRules-2009 - Thai) (Effective July 9, 2009)
Ministry of Public Health
(7) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Notice: Preface, 2-3, and 5
(8) (Regulation) Notification of the Food and Drug Administration: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (ECReg&Proc-2018 - Thai) (Effective September 10, 2018)
Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 5
(9) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CT-DIPApp - English, unofficial version) (September 2009)
International Affairs and Investigational Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 14.2 and 16.2
(10) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom for Clinical Research in the Case of Biomedical Drugs (FDA 1) (PubGuide-ClinBiolProdReqs - Thai) (Effective 29/01/2559 in Thai calendar; January 1, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
(11) (Guidance) Public Guide: Permission to Bring or Order Medicine into the Kingdom For Clinical Research In the Case of Medicines in Humans, Except for Biologic Drugs (FDA1) (PubGuide-ClinDrugReqs - Thai) (Effective 22/06/2559 in Thai calendar; June 6, 2016 in Western Calendar)
Thai Food and Drug Administration, Ministry of Public Health
Summary

Overview

According to TFDA-ClinDrugReqs, the DrugAct, ECReg&Proc-2018, DrugImprtRules-1989, DrugImprtRules-2009, TFDA-ClinDrugLicenseReqs, PubGuide-ClinDrugReqs, PubGuide-ClinBiolProdReqs, TFDA-ClinDrugProdReqs, TFDA-ClinDrugImprt2017, and THA-16, 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.

The Thai FDA is also responsible for authorizing the import of IPs. The Thai FDA’s approval of a drug import permit application for clinical trial purposes serves as the import license. THA-18 provides access to this application form, which is referred to as the Application for Permission to Import or Order Drugs into the Kingdom for Research Purposes (Nor Yor Mor 1) by the Thai FDA.

In addition, as per TFDA-ClinDrugReqs, the DrugAct, G-CT-DIPApp, and THA-16, 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 codes of Good Manufacturing Practice
  • A Certificate of Analysis for each batch of IPs (must be in Thai if the manufacturer is foreign)
  • A Certificate of Free Sale
  • For a drug registered in a foreign country, Certificate of Product (CPP)/Certificate of Free Sale (CFS)/evidence of registration from the Drug Control Department from that country. A qualified translator must certify translations of these documents
  • 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

TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017 also state that the IP must be manufactured in accordance with Good Manufacturing Practice guidelines.

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

  • Import permit application form (Nor Yor Mor 1) (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)

Pursuant to TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017, the import permit will expire in four (4) years from the date of issuance. TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017 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.

The DrugAct further specifies that a license will remain valid until December 31st 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. 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 permit to operate his/her business until a final decision is issued by the Minister.

TFDA-ClinDrugReqs 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 can exceed 20% to cover drug damage. Please refer to TFDA-ClinDrugReqs for more detailed IP supply requirements.

In addition, per G-CT-DIPApp, after the import permit 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 permit (Nor Yor Mor 1) (THA-18), 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 TFDA-ClinDrugReqs.)

Furthermore, per G-CT-DIPApp, after the import permit is granted, the applicant must 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 Sponsorship topic, Quality, Data & Records Management subtopic for detailed notification requirements)
Additional Resources
(1) (Article) Thailand’s Clinical Trial Regulatory Scenario – Simplified (2/2) (THA-2) (September 26, 2016)
Credevo
Relevant Sections: Import Permit from FDA - Documents Required
(2) (Form) Notification of the Food and Drug Administration Regarding the Requirements for the Importation or Ordering of Drugs into the Kingdom for Clinical Research - Appendices (THA-18 - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Appendix 1: Application Form for Permission to Import or Order Drugs into the Kingdom for Research Purposes (Nor Yor Mor 1)
(3) (Form) Self-Submission Form for New Drug Registration Application Form (Except Biological Substances) (THA-17 - Thai) (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health
(4) (Form) Self-Submission Form for the Authorization, Production, Packaging, Importing or Ordering Placebos into the Kingdom (THA-24 - Thai) (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health
(5) (Form) Self-Submission Form for the Registration of a New Biological Drug Formula (Except Human Biological Vaccines) (THA-25 - Thai) (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health
(6) (Form) Self-Submission Form to Request Permission to Import or Order Drugs into the Kingdom for Clinical Trials (FDA 1) (THA-16 - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Investigational Products > IMP/IND Quality Requirements
Last content review/update: August 26, 2020
Requirements
(1) (Legislation) Drug Act B.E.2510 (A.C. 1967) and its Amendments (DrugAct - Thai) (Last Amended April 16, 2019) (Effective October 13, 2019)
National Assembly
Relevant Sections: Chapter III (25 and 27)
(2) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for Importing or Ordering Drugs in the Kingdom for Clinical Research (TFDA-ClinDrugLicenseReqs - Thai) (Effective September 17, 2018)
Office of the Board of Directors, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3
(3) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Preface, 1.7, 1.11, 1.13, and Appendices 2-3, 7-11, and 18
(4) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018 (TFDA-ClinDrugProdReqs - Thai) (Effective September 25, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3
(5) (Regulation) Notification Regarding the Requirements for Bringing Drugs into the Kingdom (TFDA-ClinDrugImprt2017 - Thai) (March 20, 2017)
Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Notice: 3
(6) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CT-DIPApp - English, unofficial version) (September 2009)
International Affairs and Investigational Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3, 6, 10, and 14.1
(7) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 5 (6.2, 12.2, and 13)
Summary

Overview

In accordance with TFDA-ClinDrugReqs, 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 now implementing THA-28.

IB Content Requirements

As specified in G-ResEthics and TFDA-ClinDrugReqs, 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.

TFDA-ClinDrugReqs also indicates that evidence must be provided that the IB has been submitted to the ethics committee.

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.

TFDA-ClinDrugReqs, TFDA-ClinDrugLicenseReqs, TFDA-ClinDrugProdReqs, and TFDA-ClinDrugImprt2017 also state that the IP must be manufactured in accordance with Good Manufacturing Practice (GMP) guidelines.

(See the Investigational Products topic, Product Management subtopic for additional information on IP supply, storage, and handling requirements).

Certificate of Analysis and Drug Manufacturing Certificate Requirements

As stated in TFDA-ClinDrugReqs, the DrugAct, and THA-16, the Thai Food and Drug Administration (Thai FDA) requires the manufacturer to provide the following:

  • 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

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 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 TFDA-ClinDrugReqs):

  • 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

(See Clinical Trial Lifecycle topic, Submission Process and Submission Content subtopics for detailed application requirements).

Additional Resources
(1) (Form) Self-Submission Form for New Drug Registration Application Form (Except Biological Substances) (THA-17 - Thai) (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health
(2) (Form) Self-Submission Form for the Authorization, Production, Packaging, Importing or Ordering Placebos into the Kingdom (THA-24 - Thai) (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health
(3) (Form) Self-Submission Form for the Registration of a New Biological Drug Formula (Except Human Biological Vaccines) (THA-25 - Thai) (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health
(4) (Form) Self-Submission Form to Request Permission to Import or Order Drugs into the Kingdom for Clinical Trials (FDA 1) (THA-16 - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(5) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.36, 5.14, and 7
Investigational Products > Labeling & Packaging
Last content review/update: August 26, 2020
Requirements
(1) (Regulation) Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials (TFDA-ClinDrugReqs - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 1.5 and Appendices 2-3
(2) (Guidance) Guideline on Submission of Application for Drug Import Permit into Thailand for Clinical Trial (G-CT-DIPApp - English, unofficial version) (September 2009)
International Affairs and Investigational Drug Section, Drug Control Division, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: 3 and 8
(3) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 5 (13.1)
Summary

Overview

Investigational product (IP) labeling in Thailand must comply with the requirements set forth in TFDA-ClinDrugReqs, G-ResEthics, G-CT-DIPApp, the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28), THA-16, and THA-5. Per an in-country subject matter expert, Thailand is now 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. The TFDA-ClinDrugReqs and G-CT-DIPApp specify that the drug labels must include the following information in Thai or English (Note: The regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source):

  • Drug product (non-proprietary or common name) or code and strength(s) of active ingredient
  • Research project code (or trial number) and/or project name
  • Batch number
  • Number or letter of production
  • How to use the drug if the participant(s) are using the drug by him/herself (e.g., taking drugs home for use). Instructions should be in Thai or in language that the participant(s) understand
  • Sponsor name and address
  • Expiration or retest date
  • Storage conditions
  • Include a message stating "For Research Only" in Thai
  • Requirements for Package Inserts (for registered drug)

According to an in-country subject matter expert, the label or picture of the label of all containers must also be similar to the real label. In addition, in the event the label is smaller than three (3) square inches, the label should include items in the first three (3) bullets listed above. 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.

Additional Resources
(1) (Article) Medicinal Product Regulation and Product Liability in Thailand: Overview (THA-5) (January 1, 2020)
Practical Law
(2) (Form) Notification of the Food and Drug Administration Regarding the Requirements for the Importation or Ordering of Drugs into the Kingdom for Clinical Research - Appendices (THA-18 - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
Relevant Sections: Appendix 1: Application Form for Permission to Import or Order Drugs into the Kingdom for Research Purposes (Nor Yor Mor 1)
(3) (Form) Self-Submission Form for New Drug Registration Application Form (Except Biological Substances) (THA-17 - Thai) (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health
(4) (Form) Self-Submission Form for the Authorization, Production, Packaging, Importing or Ordering Placebos into the Kingdom (THA-24 - Thai) (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health
(5) (Form) Self-Submission Form for the Registration of a New Biological Drug Formula (Except Human Biological Vaccines) (THA-25 - Thai) (Date Unavailable)
Thai Food and Drug Administration, Ministry of Public Health
(6) (Form) Self-Submission Form to Request Permission to Import or Order Drugs into the Kingdom for Clinical Trials (FDA 1) (THA-16 - Thai) (Effective May 31, 2018)
Clinical Research Medicine Pre-Market Supervision Group, Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health
(7) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 5.13
Investigational Products > Product Management
Last content review/update: August 26, 2020
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: Annex 5 (5.11, 6.2, 13 and 14)
Summary

Overview

In accordance with 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) 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. Per an in-country subject matter expert, Thailand is now implementing THA-28.

Investigational Product Supply, Storage, and Handling Requirements

As defined in G-ResEthics and THA-28, the sponsor or his/her designated CRO must also supply the investigator(s)/institution(s) with the 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.

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.

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.

Additional Resources
(1) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (THA-28) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.33, 4.9, 5.5, 5.13-5.14, and 7
Specimens > Definition of Specimen
Last content review/update: August 26, 2020
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 1.4, 7.5-7.7, and Annex 8
Summary

Overview

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.

Additional Resources
No additional resources
Specimens > Specimen Import & Export
Last content review/update: August 26, 2020
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 7.5 and Annex 8
Summary

Overview

Information is currently unavailable regarding the Thai Food and Drug Administration (Thai FDA)’s role in approving the import and export of biological specimens. However, G-ResEthics does state 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.

Additional Resources
(1) (Document) Guidelines and Procedures for Conducting Research on Human Subjects (THA-13 - Thai and English) (Date Unavailable)
Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Relevant Sections: Material Transfer Agreement (p. 83) and Material Transfer Record (p. 87)
Specimens > Consent for Specimen
Last content review/update: August 26, 2020
Requirements
(1) (Guidance) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 (G-ResEthics) (Thai) (December 2007)
Sueblinwong, Tada; Mahaisavariya, Punkae; Panichkul, Suthee (eds.), Forum for Ethical Review Committees in Thailand
Relevant Sections: 3.1 and 7.5-7.7
Summary

Overview

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 Informed Consent topic, Required Elements and Participant Rights subtopics for additional information on informed consent).

Human Tissue Sample Consent Requirements

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.

Human Genetic Research Consent Requirements

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.

Additional Resources
No additional resources
Sections Country Announcement
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COVID-19 Guidance

On May 26, 2020, Thailand's Food and Drug Administration issued guidance to sponsors and investigators regarding the conduct of clinical trials during the COVID-19 outbreak. The guidelines provide examples of flexible approaches to ensure participant safety while still complying with good clinical practices and maintaining data integrity.

This message was reviewed on January 20, 2021
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