UK – 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

New regulatory recognition routes for medicines will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States, the Medicines and Healthcare products Regulatory Agency has announced today.

This means that patients will have access to safe and effective medicines that have been approved by trusted regulatory partners in other countries. The new international recognition routes will sit alongside the MHRA’s own unique innovation pathway for medicines which integrates early regulatory advice with health technology assessment advice.

These recognition routes, which have been facilitated by existing international partnerships such as those developed through the Access Consortium and Project Orbis, mark the start of a new international recognition framework for medicines that will be in place by the first quarter of 2024…