IRP - some practical experience

I have been working with clients looking at the suitability of the International Recognition Procedure (IRP) and thought it would be useful to share some thoughts:

• What is the IRP? The Medicines and Healthcare products Regulatory Agency (MHRA) introduced the IRP on 1 January 2024, replacing the EC Decision Reliance Procedure (ECDRP). It allows the MHRA to recognise approvals from trusted international regulators, streamlining medicine authorisation in the UK.

• Which regulators are recognised? The MHRA accepts approvals from seven reference regulators: Australia, Canada, the European Commission, Japan, Switzerland, Singapore, and the USA.

• How does it work? Companies applying for UK authorisation via IRP must have already received approval for the same product from a recognised regulator. The MHRA then conducts a targeted assessment, considering the expertise of the reference regulator while retaining the right to reject applications if evidence is insufficient.

• Post-authorisation procedures: The IRP also applies to line extensions, variations, and renewals, ensuring continued regulatory oversight throughout a medicine’s lifecycle.

• Impact on UK healthcare: The IRP aims to accelerate patient access to innovative medicines while maintaining high safety standards. It also helps the UK remain globally competitive in pharmaceutical regulation following Brexit.

This approach strengthens international collaboration while ensuring UK patients benefit from faster access to approved medicines.

However, although this seems clear and easy in reality there can be issues, for instance the MHRA want unredacted assessment reports which some regulators do not supply to the applicant. The MHRA does have a good contact point which is responsive and can help navigate the process.

If you have a product and are potentially interested in IRP then PharmaGuard is here to help you. Please do reach out to us.