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September 15, 2023

Thailand Updates Rules on Conditional Approval for Emergency Use of Medicinal Products

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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.

Distribution

The 2023 FDA notification also clearly defines permissible distribution channels based on the dosage form of drug products:

  • Vaccines can be distributed to governmental organizations that have a duty to prevent or treat diseases, such as the Thai Red Cross Society (TRCS), the Government Pharmaceutical Organization (GPO), public hospitals, private hospitals, medicinal clinics, or other organizations specified by the Thai FDA.
  • Pills taken orally can be distributed to the entities listed in the previous item and to pharmacies, but a prescription is required for the drugs to be dispensed by a pharmacist.
  • Other drug products can be distributed to governmental organizations that have a duty to prevent or treat diseases, such as the TRCS, the GPO, or public hospitals.

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:

  • The registration dossier must be prepared using the required template, and it must be submitted along with a risk management plan that includes risk minimization measures. During the assessment, the Thai FDA may rely on an assessment report provided by stringent overseas regulatory authorities, including the USA, the EU, Australia, Japan, or the WHO.
  • Following registration approval, the company must implement a patient registry system and submit regulatory records to the Thai FDA.
  • The storage and distribution of drug products approved under the conditional approval mechanism must comply with the good storage practices (GSP) and good distribution practices (GDP).
  • Marketing authorization license holders must also prepare and submit regulatory reports as required by the Thai FDA (e.g., importation report, sales report)

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.

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