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Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines.
The European Union (EU) and Japan have agreed to extend the scope of their mutual recognition agreement (MRA) to cover a wider range of medicines for which each other’s inspections of manufacturing sites will be recognized. This marks the first update of the original MRA agreement between the two parties, which has been operational since May 29, 2004.
The extended scope now includes sterile medicines, certain biological medicines, including vaccines and immunological product, and APIs of any medicine covered in the agreement. 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.
The MRA reduces duplication of inspections, hence, enabling regulators to make better use of their inspection resources. It allows the EU and Japan to recognize 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.
Inspections of European manufacturing sites are carried out by national competent authorities from EU member states, whereas in Japan, GMP inspections are conducted by the Pharmaceuticals and Medical Devices Agency (PMDA) and the 47 inspectorates of the prefectures.
The full scope of the EU–Japan MRA now covers chemical pharmaceuticals, homeopathic medicinal products (as long as treated as medicinal products and subject to the GMP requirements in Japan), vitamins, minerals, and herbal medicines (if considered as medicinal products in both parties); certain biological pharmaceuticals including immunologicals and vaccines, APIs for any of the above categories and sterile products belonging to any of the above categories.The scope expansion means that Japan has evaluated and will recognize as equivalent all EU competent authorities for human medicines inspection.