Guidance published on the new international regulatory recognition routes for medicines approvals
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued detailed guidance on the new International Recognition Procedure (IRP) for medicines manufacturers, including how to apply for a medicine licence.
Following announcement in May of the new scheme to replace the current EC Decision Reliance Procedure (ECDRP) on 1 January 2024, this guidance informs the sector on how they can use the scheme to apply for a medicine licence in the UK, following approval by trusted regulatory partners in Australia, Canada, the European Union, Japan, Switzerland, Singapore, and the United States.
This means that patients will have faster access to safe, effective cutting-edge medicines through our review and by leveraging the expert decision-making of our regulatory partners to streamline assessments of specific products, while maintaining the power of the MHRA as a sovereign regulator to scrutinise each application and the authority to reject them if the evidence provided is considered insufficiently robust.
At the time of the UK’s exit from the European Union, the MHRA introduced temporary routes to market for European approved products in Great Britain, known as EU ‘reliance’ routes, to ensure that patients could continue to have timely access to new treatments. These temporary routes will end on 31 December 2023. The MHRA is currently running a public consultation on their closure that will close on 27 September 2023.
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International Recognition Procedure
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Notes to editors
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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