Thailand Profile Updated
The Thailand profile in ClinRegs has been reviewed and updated with the following information:
- 2026 notice and guidance from the Thai Food and Drug Administration (Thai FDA) and the Central Research Ethics Committee (CREC) regarding decentralized clinical trials (See Scope of Assessment, Scope of Review, Initiation, Agreements & Registration, the Sponsorship topic, Documentation Requirements, Product Management, and Consent for Specimen)
- Updated 2025 Thai FDA regulation related to the composition and functions of ethics committees (See Ethics Committee, Scope of Review, and Oversight of Ethics Committees)
- Updated 2025 Thai FDA regulation regarding drug authorization review fees (See Regulatory Fees)
- 2025 resources and updated webpage from the CREC and the Foundation for Human Research Promotion in Thailand regarding ethical review fees (See Ethics Committee Fees)
- 2025 forms for accessing the E-Consult System (See Submission Process)
- Updated and additional references to CREC webpages throughout the profile (See Ethics Committee, Scope of Review, Submission Process, and Timeline of Review)
- Updated researcher code of ethics from the National Research Council of Thailand (See Scope of Review, Initiation, Agreements & Registration, Site/Investigator Selection, Documentation Requirements, and Participant Rights)
- Updated links and added information regarding DGA Digital ID and E-Consult System Services (See Submission Process and Definition of Sponsor)
- Updated and additional Thai FDA contact information (See Regulatory Authority)
- References to CREC and the Foundation for Human Research Promotion in Thailand announcements regarding certain review procedures (See Scope of Review)
- References to 2024 and 2025 regulations regarding approval of drug research studies for the purpose of providing data for drug registration (See Scope of Assessment and Submission Process)
- References to the ICH Guidelines for Good Clinical Practice E6(R3) for drug clinical trials throughout the profile
- Reference to Thai FDA webpage related to advanced medical therapy products (See Scope of Assessment)
Sources Added During this Update:
(Guidance) Thailand’s National Guideline on Decentralized Clinical Trial (G-Decntrl - Thai) (English-G-Decntrl – Google Translation) (Last Modified July 10, 2026)
Thai Food and Drug Administration and Central Research Ethics Committee
(Notice) Official Document No. STh 1009/W 12623: Thailand’s National Guideline on Decentralized Clinical Trial (N-Decntrl - Thai) (July 3, 2026)
Thai Food and Drug Administration
(Regulation) Notification of the Food and Drug Administration Re: the Standards, Applications, and Reporting Related to Drug Research Studies to Provide Data for Drug Registration (ClinDataDrug - Thai) (Effective January 25, 2025)
Thai Food and Drug Administration
(Regulation) Notification of the Ministry of Public Health Re: the Criteria, Methods, and Conditions for Drug Research Studies to Provide Data for Drug Registration (B.E. 2566) (CritDrugReg - Thai) (English-CritDrugReg – Google Translation) (Effective March 1, 2024)
Ministry of Public Health
(Document) Announcement Regarding “Criteria for Considering Research Project Review Fees in Special Cases” (THA-114 – Thai) (English-THA-114 – Google Translation) (Effective July 8, 2025)
Foundation for Human Research Promotion in Thailand
(Document) Announcement Regarding “Research Projects Involving Humans That are Exempt from Committee Review” (THA-111 – Thai and English) (English-THA-111 – Google Translation) (June 15, 2020)
Central Research Ethics Committee
(Document) Announcement Regarding “Research Projects/Research Reports Eligible for Expedited Review” (THA-110 – Thai and English) (English-THA-110 – Google Translation) (June 15, 2020)
Central Research Ethics Committee
(Document) Announcement Regarding the Guidelines for Issuing Certificate of Approval (THA-113 – Thai) (English-THA-113 – Google Translation) (Effective June 21, 2024)
Foundation for Human Research Promotion in Thailand
(Document) Announcement Regarding Types of Amendments to Research Protocol Documents (Site-Specific) (THA-112 – Thai) (English-THA-112 – Google Translation) (Effective October 20, 2023)
Foundation for Human Research Promotion in Thailand
(Form) Requesting Access Rights for an Individual (General Public, Entrepreneurs, Researchers) – E-Consult System Access Request Form (THA-118 - Thai) (English-THA-118 – Google Translation) (Last Updated June 11, 2025)
Division of Innovative Health Products and Services, Thai Food and Drug Administration
(Form) Requesting Access Rights for Legal Entities (Agency Representatives, Registration Agents, and Researchers Submitting Applications on Behalf of an Agency) – E-Consult System Access Request Form (THA-120 - Thai) (English-THA-120 – Google Translation) (Last Updated June 11, 2025)
Division of Innovative Health Products and Services, Thai Food and Drug Administration
(Webpage) About Us (THA-115 - Thai) (Current as of October 22, 2026)
Central Research Ethics Committee
(Webpage) Advanced Therapy Medicinal Products (ATMPs) (THA-122 - Thai) (Current as of October 22, 2026)
Thai Food and Drug Administration
(Webpage) Division of Innovative Health Products and Services – About Us (THA-123 - Thai) (Current as of October 22, 2026)
Division of Innovative Health Products and Services, Thai Food and Drug Administration
(Webpage) Frequently Asked Questions (THA-116 -Thai) (Current as of October 22, 2026)
Central Research Ethics Committee
(Webpage) OSSC (THA-121 - Thai) (Current as of October 22, 2026)
Division of Innovative Health Products and Services, Thai Food and Drug Administration
(Webpage) System User Manual and Videos (for Business Operators) (THA-119 - Thai) (May 25, 2023)
Division of Innovative Health Products and Services, Thai Food and Drug Administration
Sources Revised During this Update:
(Regulation) Notification of the Food and Drug Administration Re: Rules, Procedures, and Conditions for the Acceptance of Human Research Ethics Committees Reviewing Clinical Trial Protocols Involving Drugs (ECRegProc - Thai) (Effective October 30, 2025)
Thai Food and Drug Administration
(Regulation) Notification of the Ministry of Public Health Re: Fees to be Collected from Applicants for the Drug Authorization Review Process (B.E. 2568) (ClinDrugFees - Thai) (Effective December 31, 2025)
Thai Food and Drug Administration
(Document) Research Ethics and Guidelines for Practice (THA-14 – Thai) (4th Edition) (2013)
National Research Council of Thailand
(Form) CREC - Financial Information/Financial Statement (THA-50 - Thai) (English-THA-50 - Google Translation) (Version 3.0) (August 14, 2025)
Central Research Ethics Committee
(International Guidance) ICH Harmonised Guideline: Guideline for Good Clinical Practice E6(R3) (THA-28) (January 6, 2025)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(Webpage) About the Organization (THA-44 - Thai) (Current as of October 22, 2026)
Central Research Ethics Committee
(Webpage) CREC - Research Ethics Review: Online Submission System (THA-19 - Thai) (Current as of October 22, 2026)
Central Research Ethics Committee
(Webpage) DGA Digital ID (THA-89 - Thai) (Current as of October 22, 2026)
Digital Government Development Agency
(Webpage) E-Consult System Services (THA-77 - Thai) (August 27, 2025)
Division of Innovative Health Products and Services, Thai Food and Drug Administration
(Webpage) Medicines Regulation Division - Contact Us (THA-72 - Thai) (Current as of October 13, 2026)
Thai Food and Drug Administration
(Webpage) Payment of Project Review Fees (THA-25 - Thai) (Current as of October 22, 2026)
Central Research Ethics Committee
(Webpage) Project Submission Channels (THA-95 - Thai) (Current as of October 22, 2026)
Central Research Ethics Committee
(Webpage) Review Projects Subject to CREC Consideration (CREC Eligibility Assessment) (THA-117 -Thai and English) (Current as of October 22, 2026)
Central Research Ethics Committee