Thailand Profile Updated

August 27, 2025
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The Thailand profile in ClinRegs has been reviewed and updated with the following information:

  • Additional and updated documents, forms, and webpages related to Central Research Ethics Committee clinical trial approval processes (see the Ethics Committee topic, Submission Process, Submission Content, and Timeline of Review)
  • Additional and updated Thai Food and Drug Administration (Thai FDA) Import and Export Inspection Division webpages and application forms regarding importing drugs for research (see Submission Process)
  • Additional Thai FDA webpage with information on submitting power of attorney to access the Thai FDA’s One Stop Service & Consultation Center (OSSC) (see Regulatory Fees and Submission Process)
  • Additional information on informed consent/assent for clinical trials involving children and minors (see Children/Minors)
  • Additional Thai FDA webpage with forms regarding the authorization of ethics committees (see Oversight of Ethics Committees)
  • Reference to Thai FDA guidelines on conditional authorization of advanced medical products (See Scope of Assessment)
  • Updated adverse event reporting form (see Forms)

 

Sources Added During this Update:

(Guidance) Guidelines for Conditional Authorization of Advanced Medical Products (G-ATMPAuth - Thai) (October 24, 2024)
Thai Food and Drug Administration

(Document) Announcement of Document Processing Fees for “Request for Amendment of Certification Document” (THA-108 - Thai) (Effective December 1, 2023)
Central Research Ethics Committee, National Research Council of Thailand

(Document) Local Ethics Committee Information (THA-94 - Thai) (Update 4) (Date Unavailable)
Central Research Ethics Committee, National Research Council of Thailand

(Document) Notification of New Guidelines for Conducting Multi-Institutional Research Projects (THA-97 - Thai) (English-THA-97 – Google Translate) (March 6, 2025)
Foundation for Human Research Promotion in Thailand, National Research Council of Thailand

(Form) Declaration of Conflict of Interest (AP 06-S04) (THA-103 – Thai and English) (English-THA-103 – Google Translate) (Version 5.1) (July 24, 2024)
Central Research Ethics Committee, National Research Council of Thailand

(Form) List of Documents (AP 08-S04) (THA-96 - Thai) (English-THA-96 – Google Translate) (Version 5.1) (February 5, 2025)
Central Research Ethics Committee, National Research Council of Thailand

(Form) List of Items Attached to N.D.W. (THA-106 - Thai) (Date Unavailable)
Import and Export Inspection Division, Thai Food and Drug Administration

(Form) Patient Information Sheet Checklist (AP 09-S04) (THA-109 - Thai) (English-THA-109 – Google Translation) (Version 5.1) (July 24, 2024)
Central Research Ethics Committee, National Research Council of Thailand

(Form) Request for Officers at the Import Checkpoint to Inspect Drugs Brought or Ordered into the Kingdom for Research, Analysis, Exhibition, or Charitable Donation (Form N.D.W.) (THA-105 - Thai) (English-THA-105 – Google Translate) (Date Unavailable)
Import and Export Inspection Division, Thai Food and Drug Administration

(Form) Submission Form for Biomedical Research (AP 04-S04) (THA-102 - Thai) (English-THA-102 – Google Translation) (Version 5.1) (July 24, 2024)
Central Research Ethics Committee, National Research Council of Thailand

(Webpage) Acceptance of the Committee for Consideration of Ethics in Human Research - Form (THA-107 - Thai) (Current as of August 22, 2025)
Thai Food and Drug Administration

(Webpage) Amendment Report Type (Site-Specific) (THA-99 - Thai) (May 16, 2024)
Foundation for Human Research Promotion in Thailand, National Research Council of Thailand

(Webpage) CREC - Calendar (THA-101 - Thai) (Current as of August 22, 2025)
Central Research Ethics Committee, National Research Council of Thailand

(Webpage) CREC - Flow Chart of Project Review Process (THA-98 - Thai) (Current as of August 22, 2025)
Central Research Ethics Committee, National Research Council of Thailand

(Webpage) CREC - Form for Submitting Research Project Documents (Standard Operating Procedures (SOPs) Version 5.1, Dated July 24, 2024) (THA-93 - Thai) (Current as of August 22, 2025)
Central Research Ethics Committee, National Research Council of Thailand

(Webpage) CREC - Project Submission Channels (THA-95 - Thai) (Current as of August 22, 2025)
Central Research Ethics Committee, National Research Council of Thailand

(Webpage) CREC - Project Submission Process with CREC (THA-100 - Thai) (Current as of August 22, 2025)
Central Research Ethics Committee, National Research Council of Thailand

(Webpage) Frequently Asked Questions - Research Ethics (THA-92 - Thai) (Current as of August 22, 2025)
National Science and Technology Development Agency

(Webpage) Power of Attorney (THA-104 - Thai) (April 28, 2025)
Import and Export Inspection Division, Thai Food and Drug Administration

Sources Revised During this Update:

(Document) Account Details for the Foundation for the Promotion of Human Research in Thailand (THA-42 – Thai and English) (English-THA-42 – Google Translation) (Date Unavailable)
Central Research Ethics Committee, National Research Council of Thailand

(Form) Application Form for Medicine Importation (THA-84 - English and Thai) (February 28, 2025)
Import and Export Inspection Division, Thai Food and Drug Administration

(Form) Health Product Adverse Event Report Form (HPVC Form-1) (THA-22 - Thai) (English-THA-22 - Official Translation) (August 1, 2024)
Health Product Vigilance Center (HPVC), Thai Food and Drug Administration

(Form) Protocol Package Checklist Form (AO 01-S04) (THA-34 - Thai) (English-THA-34 - Google Translation) (Version 5.1) (October 15, 2024)
Central Research Ethics Committee, National Research Council of Thailand

(Webpage) CREC - Research Project Submission Guide (THA-47 - Thai) (Current as of August 22, 2025)
Central Research Ethics Committee, National Research Council of Thailand

(Webpage) E-Consult System Services (THA-77 - Thai) (February 10, 2025)
Division of Innovative Health Products and Services, Thai Food and Drug Administration

(Webpage) Forms for Pharmaceutical Products (THA-85 - Thai) (March 31, 2025)
Import and Export Inspection Division, Thai Food and Drug Administration

(Webpage) Importing Drugs for Other Purposes (THA-79 - Thai) (February 21, 2025)
Import and Export Inspection Division, Thai Food and Drug Administration

(Webpage) Payment of Project Review Fees (THA-25 - Thai) (Current as of August 22, 2025)
Central Research Ethics Committee, National Research Council of Thailand

(Webpage) Standard Operating Procedures for the Conduct of the Central Research Ethics Committee and Its Staff (THA-37 - Thai) (Version 5.1) (July 24, 2024)
Central Research Ethics Committee, National Research Council of Thailand

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