Thai drug registration renewal: late filing closes on 13 November, after which renewal is no longer possible

What the notice says

On 12 October 2026 Thai FDA's Drug Control Division posted the slides from its 5 October follow-up meeting on registration renewals. They cover certificates renewed under the transitional provision, meaning drug registrations issued between 1 January 1983 and 13 October 2019. These certificates are valid until 12 October 2026.

• Fine-free filing: closed on 12 October 2026, under Clause 3 of the 2023 (B.E. 2566) Ministerial Regulation on renewal, which requires filing within one year before expiry.
• Late filing: possible until 13 November 2026 under Section 86/2, paragraph 3 of the Drug Act, with a fine of up to 500 baht per day until the application is filed (Section 123 quater).
• After 13 November: once a month has passed since expiry, the registration can no longer be renewed.

As of 1 October, 1,169 of the 3,503 applications due in this round had not been filed: 276 veterinary, 876 generic and new generic, 15 new drugs and 2 biologics. In the regular seven-year round, 25 of 87 were still outstanding.

A certificate stays valid after the application is filed and the fee is paid, until a refusal order is issued. Drugs that are not renewed cannot be manufactured or imported after expiry, but stock already on the market may be sold until its own expiry date and does not have to be recalled.

Business implications

Overseas manufacturers with Thai registrations should check now with their local registration holder whether renewal has been filed. 13 November is the filing deadline. After filing, document screening takes 30 working days, only one correction is allowed within 30 calendar days, and the application is returned if that deadline is missed or the documents are still incomplete.

Where Thai FDA has not yet published a reference SmPC or PIL, the existing approved leaflet is used, and the risk management plan (RMP) must include an undertaking to file a variation (ย.5) for the company's own SmPC and PIL by 13 April 2027. For products you decide not to renew, plan stock on the basis that imports stop at expiry.