In May 2023, Thailand issued a regulation on conditional approval for emergency use of medicinal products, replacing a series of similar notifications that had been issued to aid mitigation efforts during the COVID-19 pandemic.
During the pandemic, regulatory authorities worldwide—including the Thai Food and Drug Administration (FDA)—reshaped the approval pathway for emergency drugs intended for the treatment of COVID-19. The Thai FDA published five Notifications Re: Conditional Approval for the Emergency Use of Medicinal Products to outline the registration requirements and channels of distribution for drugs intended for the diagnosis, treatment, or prevention of COVID-19.
As the threat from COVID-19 was receding, the Thai FDA saw fit to prepare for the potential emergence of other serious communicable diseases by enabling the supply of timely medications for disease diagnosis, treatment, and prevention. The Thai FDA therefore cancelled the five COVID-19-related emergency use notifications, which were published in 2020 and 2022, and replaced them with the Notification Re: Conditional Approval for Emergency Use of Medicinal Products published in May 2023.
Under the May 2023 FDA notification on emergency use, conditional approval can be applied to drugs supported by empirical scientific evidence demonstrating their capacity to diagnose, treat, alleviate, cure, or prevent a serious communicable disease. The drugs eligible for approval under this new emergency pathway include novel drugs that are not yet approved in Thailand, as well as existing drugs approved in Thailand but recently discovered to have additional potential indications for the diagnosis, treatment, alleviation, cure, or prevention of a serious communicable disease.
The 2023 FDA notification also clearly defines permissible distribution channels based on the dosage form of drug products:
This differs from the COVID-19-era notifications issued between 2020 and 2022, which were less clear regarding distribution channels.
Special Regulatory Requirements
The 2023 FDA notification also enumerates several essential requirements that must be fulfilled when seeking emergency use approval. For instance:
License holders who previously obtained conditional approval for COVID-19 drugs and wish to continue their related business operations must apply for a new conditional approval under the 2023 FDA notification, before the expiration of their current marketing authorization license obtained in accordance with the previous notifications.
For more details on the 2023 FDA notification on conditional approval for emergency use, or on any aspect of medicinal product registration requirements, please contact Kittiya Nopparatrungroj at [email protected] or +66 2056 5750.