Philippines: Revision of the Guidelines on Good Manufacturing Practice (GMP) Clearance for Foreign Drug Manufacturers

 

Philippines has published a new draft Administrative Order concerning Revised Guidelines on Good Manufacturing Practice (GMP) Clearance for Foreign Drug Manufacturers.

The purpose of the revision is to update the current guidelines on the Foreign GMP Clearance requirements and the processes on application for initial, variation and renewal for foreign drug manufacturers represented by the drug distributor-importers intending to register and supply finished drug products and active pharmaceutical ingredients in the country.

The guidelines apply to all Foreign Drug Manufacturers of drug and biological products, including API as applicable, represented by a local drug distributor-importer with a valid License to Operate that intends to register and supply drug products in the country.

The responsibilities and accountabilities when drug products are imported from other countries are shared by the foreign drug manufacturers and the drug distributor-importers. The FDA Philippines requires foreign drug manufacturers through the assigned drug distributor-importer to obtain a GMP Clearance before applying for a Certificate of Product Registration, a product market authorization, prior to importing drugs products and Active Pharmaceutical Ingredients (API), when applicable into the country. The foreign drug manufacturer needs to demonstrate acceptable evidence of compliance to international GMP standards before supplying them in the country.

GMP Clearance ensures the timely supply of innovative and established pharmaceutical and biological products from other countries in an efficient and effective way while ensuring the appropriateness and suitability of manufacturing processes and quality procedures.

The GMP Clearance can be obtained primarily through a desktop assessment and/or on-site inspection by the FDA Philippines Drug GMP Inspectorate. These guidelines describe the criteria, requirements and process for regulatory reliance and recognition to determine suitability of evidence of GMP compliance for the protection of the patients and public health.

The new draft revises Administrative Order No. 2013-0022 on Guidelines for Current Good Manufacturing Practice (cGMP) Clearance and Inspection of Foreign Drug Manufacturers, and its implementing guidelines, the FDA Circular No. 2014-016.

The full text of the draft is available HERE.