Brexit: Leveraging the Mutual Recognition Agreement to Mitigate Potential Risk With Commercial Drug Product Release Testing

The Brexit1 deadline has been extended once again, now to January 31, 2020, and the status of the Brexit deal will depend on the outcome of an upcoming election scheduled for December 12. Regardless of the outcome, drug manufacturers and contract test laboratories need to be proactive and understand the potential regulatory considerations relating to commercial drug product release testing and Brexit.

This article provides a brief overview of the EU-U.S. Mutual Recognition Agreement (MRA) and discusses considerations for implementing viable alternatives for testing to support EU, U.K. and U.S. drug product releases if and when Brexit moves ahead.

Continue reading