Thailand is preparing to open its first renewal period for drug marketing authorizations (MAs) since the passage of the Drug Act (No. 6) B.E. 2562 (2019).
Before 2019, MAs for pharmaceuticals and vaccines in Thailand had lifelong validity. The 2019 Drug Act stipulated that all new MAs would be valid for seven years and could be renewed.
The 2019 law also set out expiration dates for existing pharmaceutical products registered and approved prior to the implementation of the law (i.e., before October 13, 2019):
- Drug MAs issued before January 1, 1997, expire on October 13, 2024.
- Drug MAs approved between January 1, 1997, and December 31, 2007, expire on October 13, 2026.
- Drug MAs approved between January 1, 2008, and October 13, 2019, expire on October 13, 2028.
Based on these dates, the first renewal period for drug MAs will commence in the fourth quarter of 2023. To facilitate the renewal process, the Thai Food and Drug Administration (FDA) has publicized draft regulations and notifications on the required application form and documents, the rules and conditions, and the process for renewing an MA.
In May 2023, the Thai FDA issued Ministerial Regulation Re: Renewal of Drug MA Licenses B.E. 2566 (2023) to prescribe the essential requirements for filing a renewal application:
- To renew a drug MA, holders must submit their renewal application to the Thai FDA within the one-year period before the MA’s expiration date.
- Renewal applications can only be submitted online via the Thai FDA’s electronic system.
- The Thai FDA will grant approval for an MA renewal if the following conditions are satisfied:
- The documents in relation to efficacy and safety are up-to-date, accurate, and in accordance with academic principles.
- The specification and analytical method comply with the official pharmacopeias as prescribed in the Drug Act, as amended. For noncompendial specifications or methods, justification or evidence that substantiates the quality, safety, and efficacy of the drug product must also be provided.
The ministerial regulation also provided examples of required information and documents:
- Evidence of the quality, efficacy, and safety of the drug products.
- Label and package insert.
- Documents demonstrating the patent number or petty patent number as announced in Thailand.
- GMP (Good Manufacturing Practice) clearance letter (for imported drug products).
It is expected that the official document checklist and other requirements will be published in the fourth quarter of 2023. MA holders should recheck the renewal period for their pharmaceutical products and start preparing the most up-to-date version of the drug registration dossier.
Those who obtained conditional approval for COVID-19 drugs and wish to continue their related business operations must apply for a new conditional approval under Thailand’s new rules for conditional approval before the expiration of their current MA.
For further information, please contact:
Kittiya Nopparatrungroj, Tilleke & Gibbins
kittiya.n@tilleke.com
