News about GMP/cGMP

The current mutual recognition agreement (MRA) between the EU and Japan has been operational since 29 May 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.

The full scope of the 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
• Sterile medicines that belong to any of the above categories

This is the first update of the original 14-year old MRA agreement. As part of the product scope expansion project, Japan also evaluated and recognised as equivalent all EU competent authorities for human medicines inspection.

In the EU, inspections of manufacturing sites are carried out by national competent authorities from EU Member States. In Japan, GMP inspections are conducted by the Pharmaceuticals and Medical Devices Agency (PMDA) and the 47 inspectorates of the prefectures.

Source:

EMA: Press release