Posted by Michael Wonder on 18 Jul 2018
EU and Japan reinforce their collaboration on inspections of medicine manufacturers
18 July 2018 - Update of 2004 mutual recognition agreement extends scope to sterile products, active pharmaceutical ingredients and biologicals including vaccines
The European Union (EU) and Japan have agreed to broaden the range of medicines for which they will recognise each other’s inspections of manufacturing sites.
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. 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.
