MHRA announces Cooperation with seven international Partners

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7/8 May 2024

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The U.K Medicines and Healthcare products Regulatory Agency (MHRA) is working on a new international recognition framework.
 
The aim is to leverage the expertise of seven trusted international regulatory partners:

• Singapore Health Sciences Authority
• Swissmedic
• Health Canada
• Australia's Therapeutic Goods Administration (TGA)
• European Medicines Agency (EMA)
• Pharmaceuticals and Medical Devices Agency Japan
• U.S. FDA

According to MHRA, patients in the UK will have access to safe and effective medicines that have been approved by trusted regulatory partners in other countries. This will be made possible through new international recognition routes, which will work alongside the UK's own innovation pathway for medicines.
The new framework will allow MHRA to utilize the expertise and decision-making of trusted regulatory partners to expedite assessments of specific products. This will enable advanced medicines that have already been approved in other countries to reach UK patients more quickly.

It is important to note that the MHRA will still have the responsibility of approving all applications under the new recognition framework and retains the authority to reject applications if the provided evidence is not robust enough.

While the current announcement primarily focuses on medicines, efforts are underway to establish similar recognition routes for medical devices as well. The MHRA will initiate a targeted consultation on medical devices to gather opinions on various topics, including the recognition of conformity assessments or approvals from international regulatory partners.

These recognition routes will be in place by early 2024.