UK Seeks Feedback on Plan to End EU Regulatory Reciprocity Pathway

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is seeking public feedback on a plan that would end regulatory reciprocity between the UK and the EU for drug and device review and approvals.

MHRA said last week that it has proposed amending the Human Medicines Regulations 2012 to strip away powers under the regulations that allow an approval decision from the European Commission (EC) to stand in the UK without further consideration, currently achieved via a procedure called the European Commission Decision Reliance Procedure (ECDRP). The UK regulator noted it plans to terminate the pathway by year’s end.

Starting Jan. 1, 2024, the ECDRP will be replaced by the International Recognition Procedure (IRP), which will also include the current Mutual Recognition/Decentralized Reliance Procedure (MRDCRP).

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