EU and Japan expand scope of drug manufacturers inspections

The European Union and Japan have agreed to broaden the range of medicines for which they will recognize each other’s inspections of manufacturing sites.

The current mutual recognition agreement (MRA) between the EU and Japan has been operational since May 29, 2004. It allows regulators to rely on Good Manufacturing Practice (GMP) inspections in each other’s territories, to waive batch testing of medicines that enter Japan from EU countries and vice versa and to share information on inspections and quality defects. Thanks to this agreement, regulatory authorities in the EU and Japan can make better use of their inspections resources by reducing duplication of inspections in each other’s territory.

The scope of this agreement has now been extended to include sterile medicines, certain biological medicines including vaccines and immunologicals, and active pharmaceutical ingredients (APIs) of any medicine covered in the agreement. This means that authorities from the EU and Japan have agreed that they have equivalent regulatory and procedural frameworks for inspections of manufacturers for these products and can therefore rely on each other’s inspections.