On October 20, 2010, the Philippines’ Food and Drug Administration (FDA) under the Department of Health requested comments on a draft of the new administrative order for GMP of foreign drug manufacturers. The guidelines serve to establish a formal system of evaluation, monitoring, and assurance for GMP compliance by foreign drug manufacturers. Furthermore, importers based in the Philippines will also be required to follow this order since several clauses importers to act to prevent non-GMP cleared pharmaceuticals from entering the country. The order builds off of Administrative Order 43 s. 1999 – cGMP for drugs that currently governs domestic manufacturers.
This GMP administrative order focuses on four key objectives:
- The Philippines’ FDA will release guidelines to standardize submission, review, monitoring, and archiving of GMP documents by foreign manufacturers.
- Importers must confirm GMP clearance of each product before the product begins the registration process.
- The importer continues to take on a key role by following up on the GMP of the foreign manufacturer. Evidence will need to be presented to the Philippines’ regulatory bodies periodically.
- Foreign drug manufacturers must now allow the Philippines’ FDA to conduct GMP audits.
Foreign manufacturers currently producing drugs in the Philippines should begin preparations for abiding by the Philippines’ new GMP requirements.