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

Updated February 3, 2020 – Brexit1 has been completed and the UK will now enter into a transition agreement with the EU until December 31, 2020. Until then, the current GMP regulations will continue to apply. . However, drug manufacturers and contract test laboratories should be proactive in understanding the potential regulatory considerations relating to commercial drug product release testing.

This article provides a brief overview of the EU-US Mutual Recognition Agreement (MRA) and discusses considerations for implementing viable alternatives for testing to support EU, UK and US drug product releases after Brexit.

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ECHA Decision Letters – What to Expect

The last REACH deadline was in May 2018 and brought to a close the period of active information gathering on the safety of chemical products marketed in the EU/EEA. It has resulted in a massive database of safety information on a wide range of substances and heralds an exciting new phase of evolution in scientific and regulatory thinking. So, with the data in, the decision letters start to roll out.

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