MHRA consults on ending EC Decision Reliance Procedure 4 Sep 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting feedback on plans to end use of the European Commission Decision Reliance Procedure (ECDRP) to bring medicines to market.

In order to minimise disruption to market access for medicines in the UK following Brexit, the procedure has allowed the regulator to rely on EC decisions to approve new therapies. However, in practice, the MHRA says it has had to conduct its own additional reviews in most cases.

Now, it proposes to terminate the ECDRP route on 31 December 2023 and introduce a new international recognition framework. This new framework will sit alongside three other existing pathways, namely the ACCESS Consortium, Project Orbis and the Mutual Recognition Decentralised Reliance Procedure. The government said, “ … we are now in a position to implement a more considered approach to our assessments and accept applications from a wider range of partners.”

The consultation seeks views on plans to amend the Human Medicines Regulations 2012 to remove the power for the MHRA to rely on the ECDRP. Interested parties can find out more and submit their responses via this link.

For advice on the changing regulatory landscape and your new product launch, contact PMC via hello@pharmamedic.co or T: +44 (0) 208 168 1668.