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EU, US Commit To Sharing Full Inspection Reports To Supplement GMP Mutual Recognition

 
• By Vibha Sharma

EU and US drug regulators have signed a new confidentiality commitment that allows both parties to exchange full medicine inspection reports with each other. This was not possible before.

Business men exchanging files
EU, US Can Exchange Full Medicine Inspection Reports • Source: Shutterstock

Drug regulatory authorities in the EU and the US will be able to exchange full medicine inspection reports with each other under a new confidentiality commitment signed by the two regions. The initiative aims to improve patient safety on both sides of the Atlantic and to allow EU and US regulators to make better use of their inspection resources.

The new confidentiality commitment, involving the European Commission, the European Medicines Agency and the US Food and Drug Administration, will help with the implementation of the EU-US mutual recognition agreement,...

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