Thailand Introduced New Regulations On Drugs Imported for Clinical Trials

On March 1, 2024, new regulations governing drugs imported into Thailand for clinical studies will come into effect, transforming Thailand’s clinical trial landscape. These regulations introduce a detailed framework for the importation of drugs for clinical studies. Notably, while there were no specific requirements governing Clinical Trial Applications (CTAs) before, the new rules mandate the submission of a CTA, which must be approved by the Thai FDA before any clinical study begins. This permit will have a five-year validity and can be renewed.

Another critical change is the enhanced oversight and post-approval obligations outlined in the new regulations. The Thai FDA will now actively inspect and oversee clinical studies throughout different phases, including the authority to modify, suspend, or cancel studies. This is a significant shift from the past, where the focus was primarily on the approval process without explicit mention of ongoing oversight.

Furthermore, the new rules specify detailed reporting requirements, including the submission of progress reports and adverse event reports. This level of detailed oversight and reporting is designed to align Thailand’s clinical practices with international standards, such as those set by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines, which were already a part of the old rules, but are now being reinforced.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

Source used in the article:–thailand.pdf?rev=3372c4f88ce64393a11ebd75b65bd6e7&sc_lang=en&hash=24A9E756682CDCAB6B443F4B8166CE65