Thailand Profile Updated in ClinRegs
July 22, 2021
The Thailand profile in ClinRegs has been reviewed and updated to reflect all current regulatory requirements. Key updates include:
- Updated clinical trial drug importation license application submission instructions to the Thai Food and Drug Administration (Thai FDA)’s Division of Innovative Health Products and Services via Skynet, email, or postal mail (See Submission Process and Timeline of Review)
- Revised fees to submit a clinical trial drug importation license application and new payment instructions (See Regulatory Fees)
- New regulation requiring ethics committees (ECs) to complete self-submission verification form, source of income disclosure statement, and conflict of interest form (See Ethics Committee)
- Revised list of Thai FDA approved ECs for clinical trials (See Ethics Committee)
- Revised regulation and forms updating the Thai FDA’s labeling and packaging requirements for clinical trial drug importation license applications, including an updated labeling section in the self-submission checklist and a new drug labeling waiver form (See Labeling & Packaging)