IPEC e-newsletter - Excipients Insight July/August 2018 - 31-08-18

 

Inside this issue

     

EU, Japan expand MRA on inspections

The 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 two territories has been operational since 2004, and allows regulators to rely on good manufacturing practice (GMP) inspections in each other’s jurisdiction, 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 scope of the MRA 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. More information is available here.

 

 

 

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