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MHRA announces new regulatory recognition routes with seven international partners

May 26, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) announced the establishment of new regulatory recognition routes for medicines, utilising approvals from Australia, Canada, the EU, Japan, Switzerland, Singapore, and the US to expedite new product approvals This framework will leverage the expertise and decision-making of regulatory partners to expedite the assessment of specific products, resulting in faster access to medicines in the UK and reducing costs and streamlining regulatory processes for the industry.  The UK regulator will remain responsible for approving and/or rejecting applications under the new framework.  The MHRA expects the framework will be in place by Q1 2024.