Thailand’s Food and Drug Administration (FDA) has proposed draft amendment to the Announcement on Criteria, Procedures, and Conditions for Applying, Issuing, and Renewing Certificates of Good Manufacturing Practice (GMP) for Pharmaceutical Products from Foreign Manufacturing Facilities B.E. …. (3rd amendment) (“Draft Announcement”). After a public hearing period ending on 1 May 2024, the Draft Announcement will be presented to the Minister of the Ministry of Public Health for consideration and approval before being published in the Royal Gazette.

The proposed revisions aim to update and simplify the requirements outlined in the previous 2nd Issue of the announcement, which has been enforced since 24 March 2023. The key goals are to reduce administrative burdens for drug importers in preparing application documents, while also enabling a more streamlined and efficient evaluation process by FDA officials. This will allow more effective regulatory oversight of imported drug product quality based on current industry practices.

Key proposed changes to the certification criteria include:

1. Importers bringing in medicines from foreign facilities classified as an ASEAN Listed Inspection Service or as a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) can submit alternative documents demonstrating GMP compliance instead of a GMP Certificate or Certificate of Pharmaceutical Product (CPP) when applying for new certifications or renewals. Additionally, for PIC/S members, importers may not need to provide Corrective and Preventive Action plans when applying for new certifications.
2. For orphan drugs, veterinary medicines, and medicines from other foreign facilities not covered above, the FDA proposes to categorize document requirements based on the specific medicine type. This risk-based approach aims to facilitate more focused inspections while reducing unnecessary documentation demands.
3. In evaluating whether a foreign facility meets GMP standards, the FDA can consider alternative documents providing evidence of GMP compliance as acceptable instead of only accepting official GMP Certificates or CPPs.

The Draft Announcement allows for a more flexible, risk-based approach to verifying current good manufacturing practices at foreign facilities based on available documentation from trusted regulatory authorities. Highly regulated facilities under PIC/S would have streamlined certification renewals, while foreign sites producing orphan drugs or veterinary medicines would follow requirements commensurate with their risk profiles.

Overall, these proposed changes aim to increase efficiency for both FDA regulators and the industry while maintaining strict oversight of drug product quality, safety, and efficacy standards for imported pharmaceutical products in Thailand. The streamlined certification framework reduces administrative burdens while focusing inspection resources based on risk.

If approved, the Draft Announcement will provide an updated regulatory system better adapted to current pharmaceutical manufacturing practices and global regulatory collaboration on GMP inspections. Both importers and the Thai FDA could benefit from a more modern, agile system for ensuring public health protection.