DOOSIGAN / Thailand regulatory updates
We review recent notices from Thai regulators and explain their practical impact by product category.
01 / Regulatory updates
3 regulatory updates
Thai FDA's Drug Control Division has restated the renewal timeline for drugs registered before 13 October 2019. The fine-free filing deadline of 12 October has passed. Applications can still be filed until 13 November with a daily fine of up to 500 baht, after which renewal is no longer possible.
Thai FDA has posted the Type 2 submission checklist for renewing human modern drug registrations. It covers generic, new generic and low-risk medicines, and excludes Transfer registrations whose quality dossier has not been brought up to ASEAN or ICH guidelines.
Thai FDA reminded relevant license holders to complete production, import and sales reporting for listed controlled drugs for May–August 2026 by 30 September. Operators should confirm whether FDA Reporter, Track and Trace, or both apply.
