Thailand

DCT Feasibility Assessment Thailand The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers ...

This workbook provides an overview of the current regulatory landscape in Thailand in relation to Decentralized Clinical Trials (“DCTs”). Thailand abides by the regulations set forth by the Thai Food and Drug Administration (FDA). The regulations i...

2.1 Name of Regulatory Authority In Thailand, drugs, medical devices, food, narcotics, cosmetics, and hazardous substances are regulated by the Thai Food and Drug Administration.  https://en.fda.moph.go.th/ 2.2 Name of Ethic...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.  The Thai FDA accepts paper and electronic clinical trial application submission packag...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  Sponsors must submit one original set and two copies of the following documents to the ...

5.1 Does local regulation require PI/CI to be approved/registered by any regulatory authority (e.g., RA/EC)? No . In accordance with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( THA-28 ) , the ...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment.  In the case of the transfer of biological materials, the sponsor must complete the Material Transfer Agreement (MTA) form (Annex 8 of ...

7.1 Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? There is nothing preventing the conduct of a decentralized trial in Thailand, pendi...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   Data collection from clinical trials is governed mostly by Thailand's Personal Data Protection Act (PDPA) 2019 . ...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ? Yes , digital advertisement is allowed as long as the appropriate message ...

10.1 Clinical Trial with Investigational Medicinal Product  Submit CTA to  EC for approval. Upon approval, submit an application for Import Licence to the Thai FDA. 10.2 Pediatric Investigation Plan (PIP) FDA does NOT re...

Sueblinwong T, Mahaisavariya P and Panichkul S (2007) The Ethical Guidelines for Research on Human Subject in Thailand, 2007 ,  Forum for Ethical Review in Thailand RegDesk (16 November 2020) Thailand FDA on Direct Advertising and Label...

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