Thailand Profile Updated
The Thailand profile in ClinRegs has been reviewed and updated with the following information:
- Revised requirements and documentation for importing drugs for clinical research (See the Regulatory Authority, Ethics Committee, Clinical Trial Lifecycle, Sponsorship, Informed Consent, and Investigational Products topics)
- Revised requirements and documentation for producing drugs for clinical research (See the Regulatory Authority, Ethics Committee, Clinical Trial Lifecycle, Sponsorship, Informed Consent, and Investigational Products topics)
- Updated Thai Food and Drug Administration (Thai FDA) E-Submission System guideline from 2023 (see Submission Process)
- Webpage and related documents and forms providing Thai FDA drug import waiver request instructions (see Regulatory Fees and Submission Process)
- Webpage and instructions related to requesting a License Per Invoice (LPI) via the Thai FDA (see Submission Process)
- Webpages and forms for requesting permission to use the Thai FDA’s One Stop Service & Consultation Center (OSSC) E-Consult Service (see Submission Process)
- Central Research Ethics Committee (CREC) fees issued in 2022 and payment instructions (see Ethics Committee Fees)
- Updated CREC project submission documentation from 2022 and 2023 (see Submission Process, Submission Content, and Documentation Requirements)
- List of Thai FDA approved ethics committees from 2023 (see Ethics Committee and Oversight of Ethics Committees)
Sources Added During this Update:
(Regulation) Notification of the Food and Drug Administration Regarding the Establishment of an Evaluation Channel Based on the Evaluation Results of the Quality Accreditation Agency, Ethics Review Committee (EC-QualAccredReq - Thai) (Effective September 26, 2019)
Thai Food and Drug Administration
(Regulation) Notification of the Medicines Regulation Division Regarding Details of the Requirements for Importing or Ordering Drugs into the Kingdom for Clinical Research (N.Y.M.1 Applications) (ClinImprtOrdr - Thai) (English-ClinImprtOrdr - Google Translation) (Effective August 7, 2023)
Thai Food and Drug Administration
(Regulation) Notification of the Medicines Regulation Division Regarding Details of the Requirements for the Production of Modern Drug Samples for Clinical Research (P.Y.8 Application) (ClinSampleProd - Thai) (English-ClinSampleProd - Google Translation) (Effective August 7, 2023)
Thai Food and Drug Administration
(Article) How to Request a License Per Invoice (THA-88 -Thai) (August 4, 2023)
FDA Story Company Limited
(Document) CREC - Funding Source and Fee Receipt Information (THA-50 - Thai) (English-THA-50 - Google Translation) (Version 2.0) (January 10, 2024)
Central Research Ethics Committee, National Research Council of Thailand
(Document) Details of the Account Number of the Foundation for the Promotion of Human Research in Thailand (THA-42 - Thai) (Date Unavailable)
Central Research Ethics Committee, National Research Council of Thailand
(Document) Introducing the FDA Agency and General Registration Principles (THA-91 - Thai) (March 9, 2017)
Assawakitwiri, Winit; National Science and Technology Development Agency
(Document) System for Requesting a Waiver from Drug Importation (THA-87 - Thai) (July 2022)
Import and Export Inspection Division, Thai Food and Drug Administration
(Form) Application Form for Medicine Importation (THA-84 - English and Thai) (June 8, 2021)
Import and Export Inspection Division, Thai Food and Drug Administration
(Form) Documents Attached to the Notification of the Medicines Regulation Division - Details of the Requirements for the Production of Modern Drug Samples for Clinical Research (THA-76 - Thai) (English-THA-76 - Google Translation) (August 7, 2023)
Thai Food and Drug Administration
(Form) Form for Requesting Access to the FDA E-Submission System for Permission to Import Drugs for Other Purposes (THA-83 - Thai) (English-THA-83 - Google Translation) (Last Updated January 4, 2023)
Import and Export Inspection Division, Thai Food and Drug Administration
(Form) Form for Requesting Permission to Use the Health Product Consultation Information System (E-Consult) (THA-80 - Thai) (English-THA-80 - Google Translation) (Last Updated March 20, 2023)
Division of Innovative Health Products and Services, Thai Food and Drug Administration
(Form) Form Requesting Power of Attorney Access to the FDA E-Submission System for Permission to Import Drugs for Other Purposes (THA-82 - Thai) (Last Updated June 27, 2023)
Import and Export Inspection Division, Thai Food and Drug Administration
(Form) Form Requesting Power of Attorney Permission to Use the Health Product Consultation Information System (E-Consult) (THA-81 - Thai) (English-THA-81 - Google Translation) (Date Unavailable)
Division of Innovative Health Products and Services, Thai Food and Drug Administration
(Webpage) Digital ID (THA-89 - Thai) (Current as of March 20, 2024)
Electronic Government Agency
(Webpage) E-Consult System Service (THA-77 - Thai) (July 12, 2023)
Division of Innovative Health Products and Services, Thai Food and Drug Administration
(Webpage) Forms for Pharmaceutical Products (THA-85 - Thai) (April 24, 2023)
Import and Export Inspection Division, Thai Food and Drug Administration
(Webpage) Importing Drugs for Other Purposes (THA-79 - Thai) (November 19, 2023)
Import and Export Inspection Division, Thai Food and Drug Administration
(Webpage) List of Human Research Ethics Committees Accepted by the FDA (THA-90 - Thai) (Current as of March 20, 2024)
Thai Food and Drug Administration
(Webpage) Procedures for Drug Products – Process, Processing Time and Expenses (THA-78 - Thai) (Current as of March 20, 2024)
Division of Innovative Health Products and Services, Thai Food and Drug Administration
(Webpage) Steps for Using License Per Invoice (THA-86 - Thai) (Last Updated March 5, 2024)
Import and Export Inspection Division, Thai Food and Drug Administration
Sources Revised During this Update:
(Regulation) Notification of the Foundation for Human Research Promotion in Thailand, M.S.T. 011/2565 Amending the Notification of the Fees for Ethical Consideration of Human Research (CRECFees - Thai) (English-CRECFees - Google Translation) (Effective July 6, 2022)
Central Research Ethics Committee, National Research Council of Thailand
(Regulation) Notification of the Ministry of Public Health on the Expenses to be Collected from Applicants for the Drug Approval Process (ClinDrugFees - Thai) (December 2, 2023)
Thai Food and Drug Administration
(Document) Preparing for Use of the FDA E-Submissions System (THA-75 - Thai) (English-THA-75 - Google Translation) (August 22, 2023)
Thai Food and Drug Administration
(Document) Research Protocol Package Checklist (THA-34 - Thai) (English-THA-34 - Google Translation) (Version 5.0) (Updated October 31, 2023)
Central Research Ethics Committee, National Research Council of Thailand
(Document) Submitting Project Documents for Initial Protocol (THA-29 - Thai) (English-THA-29 - Google Translation) (May 19, 2022)
Central Research Ethics Committee, National Research Council of Thailand
(Form) Documents Attached to the Notification of the Medicines Regulation Division - Details of the Requirements for Importing or Ordering Drugs into the Kingdom for Clinical Research (THA-18 - Thai) (English-THA-18 - Google Translation) (August 7, 2023)
Thai Food and Drug Administration
(Webpage) Payment of Project Review Fees (THA-25 - Thai) (Current as of March 20, 2024)
Central Research Ethics Committee, National Research Council of Thailand
(Webpage) Standard Operating Procedures for the Conduct of the Central Research Ethics Committee and Office Staff (THA-37 - Thai) (Version 5.0) (October 31, 2023)
Central Research Ethics Committee, National Research Council of Thailand
(Webpage) Thai FDA Skynet E-Submission System (THA-54 - Thai) (Current as of March 20, 2024)
Thai Food and Drug Administration
(Webpage) Types of Projects Eligible for CREC Consideration and the Scope of Cooperation of Partner Institutions (THA-24 - Thai) (Current as of March 20, 2024)
Central Research Ethics Committee, National Research Council of Thailand