Initial Review Period for Thai Drug MAs to Begin Fourth Quarter of This Year

Market Authorizations (MAs) for drugs in Thailand before 2019 never expired. With the implementation of the 2019 Thai Drug Act, drug MAs were only good for 7 years but could be renewed. Now, the Thai Drug Act has set out a detailed schedule for when existing drugs would need renewals. For example, drugs approved from January 1, 2008, to October 13, 2019, will expire in October 2028 and need to be renewed to stay on the Thai market.

Given the renewal schedule discussed above, in the last quarter of this year, the first renewals will need to be completed. The Thai FDA has now outlined specific documents and processes to follow for drug makers with MA renewals. For example, drug MAs need to submit renewal applications a full year prior to expiration. Drug renewals must follow the latest drug registration requirements. Documents to submit in the renewal application include verification that your drug is still safe and effective, a GMP certificate for imported drugs, packaging and labeling information, etc. Applicants should use the Thai electronic filing system to renew a pharmaceutical MA.

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.

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