The Medicines and Healthcare products Regulatory Agency (MHRA) has issued detailed guidance on its International Recognition Procedure (IRP) for medicines manufacturers. It spells out how the sector can use the scheme to apply for a medicines license in the UK, when previously approved by its trusted regulatory partner agencies in Australia, Canada, the EU, Japan, Switzerland, Singapore and the US.

This guidance follows the announcement of the new IRP to replace the European Commission (EC) Decision Reliance Procedure from January 2024. This temporary measure, which allowed the agency to rely on the EC’s decision to authorise a medicine without any further consideration, was put in place to ensure patients could continue to have timely access to medicines following the UK’s exit from the European Union.

The transition to this new reliance model, where the MHRA will rely on the approvals made by trusted regulatory partners, means that patients should benefit from faster access to medicines through both MHRA review and by leveraging the expertise of its regulatory partners.

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