NEW | MHRA announces new recognition routes

MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners. The new recognition routes open additional options for the MHRA to bring cutting-edge medicines faster to UK patients by leveraging the expertise and decision-making of trusted regulatory partners.

MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners. The new recognition routes open additional options for the MHRA to bring cutting-edge medicines faster to UK patients by leveraging the expertise and decision-making of trusted regulatory partners.
June 7, 2023

 

The UK’s new international recognition framework will recognise marketing authorisations from Australia, Canada, the EU, Japan, Switzerland, Singapore and the US.

These recognition routes, which have been facilitated by existing international partnerships such as Access Consortium and Project Orbis, will be in place by the first quarter of 2024. The current European Commission Decision Reliance Procedure (ECDRP), in force until the end of 2023, will be superseded by this new framework.

While the international recognition routes announced focus on medicines, similar routes are also foreseen for medical devices.

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