Navigating the MHRA’s International Recognition Procedure

Since 1 January 2024, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has offered drug developers a faster route to market through its International Recognition Procedure (IRP).

In this blog, Lisa Allenby, Associate Director in Boyds’ Regulatory Operations team, outlines the process and important considerations for applicants.  

Developed by the MHRA following the UK’s departure from the EU, the IRP aims to bring life-saving medicines to UK patients, taking into account the expertise of trusted regulatory partners in other countries when authorising medicines. The scheme replaces the MHRA’s EC Decision Reliance Procedure (ECDRP).

The IRP is open to applicants that have already received an authorisation for the same product from one of MHRA’s specified reference regulators (RRs). The accepted regulators are:

• Australia – Therapeutic Goods Administration (TGA)
• Canada – Health Canada
• Switzerland – SwissMedic
• Singapore – Health Science Authority Singapoe (HSA)
• Japan – Pharmaceuticals and Medical Devices Agency (PMDA)
• Food and Drug Administration (FDA)
• EU/Europe – European Medicines Agency (EMA) and Member State Competent Authorities of the EU, Norway, Iceland and Lichtenstein

The IRP can be used for several types of marketing authorisation applications (MAAs), including:

• Regulation 50: chemical and biological new active substances and known active substances
• Regulation 51B: generic applications
• Regulation 52B: hybrid applications
• Regulation 53B: biosimilar applications
• Regulation 55: new fixed combination product applications

New IRP marketing authorisation applications (MAA)

A new MAA can be achieved via two different routes.

Recognition A is a 60-day timetable. To be eligible, the RR approval must have been granted within the previous two years.

Recognition B is a 110-day timetable and RR approval should have been granted within the previous ten years.

IRP applications should be submitted to the MHRA as one electronic Common Technical Document (eCTD) through the MHRA Submissions Platform.

Some key points to be aware of include:

• The IRP application should be in the EU format with UK-specific information included in Module 1
• Modules 2-5 of the eCTD should include all relevant information required for the MHRA application and form the baseline of the required information as approved by the RR at the MHRA submission date. This will need to comply with any EU regional requirements of the ICH eCTD standards
• Individual patient data listings (CSR appendices 16.4) typically submitted to the FDA in Module 5 are not required
• Word versions of RR assessment reports and the risk management plan are to be provided in the ‘Working documents’ folder outside of the eCTD

The full guidance is available to view here. This also details where associated RR files that do not form part of an EU/MHRA format should be placed, as well as setting out the specifics required in the cover letter. The guidance should be referred to at the time of application to ensure no information is omitted.

Benefits of the IRP

The IRP is designed to enable faster patient access to medicines by shortening MHRA review times, easing both time and resource demands on the agency. The work sharing enabled by the programme means drug developers can repurpose data packages submitted for approvals in other regions, minimising the duplication of work and supporting continued innovation whilst maintaining high regulatory standards.

Support with your regulatory operations

At Boyds, our dedicated Regulatory Operations team combines deep expertise with a proactive approach to guide you through every stage of the regulatory submission process. We manage the planning, coordination and execution of global regulatory submissions, ensuring precision, compliance and accelerated delivery for biotech and pharma companies.

Ready to accelerate your path to market? Speak with an expert today and discover how we can streamline your submission journey.