The International Recognition Procedure (IRP), introduced by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) from January 1, 2024, represents a pivotal step in the UK's approach to medicine approvals post-Brexit. This initiative is a response to the evolving global landscape of life sciences and medicine development, ensuring that the UK remains an attractive location for pharmaceutical innovation and patient access to new treatments.
What is the IRP?
The IRP is designed to facilitate the UK registration of pharmaceutical products that have already been authorised in specific high-fidelity regions, leveraging the assessment already conducted by their medicines regulators. This procedure applies to various product types including new chemical entities, fixed combination products, generic medicines, new biologicals, vaccines, and biosimilars. The countries and regions included are Australia, Canada, the European Union, Japan, Switzerland, Singapore, and the United States.
How It's Expected to Help
This new reliance procedure is expected to increase the speed and efficiency of the assessment process for new medicines in the UK. By utilizing pre-existing approvals from trusted regulatory partners, the IRP aims to provide faster access to safe and effective medicines for UK patients. It underscores the MHRA's commitment to patient safety while fostering a competitive and globally aligned regulatory environment.
Overview of the Application Procedure
The IRP offers two distinct assessment routes: Recognition A and Recognition B.
Recognition A follows a 60-day timetable without any clock stop after validation. It is suitable for applications based on approval from a Reference Regulator (RR) within the last two years, without significant divergence from the quality dossier approved by the RR.
Recognition B has a 110-day timetable with a clock stop at Day 70, allowing for up to a 60-day response period. This route is applicable for RR approvals within the last ten years and covers products with certain criteria like conditional approvals or significant manufacturing process changes.
Applicants must be established in the UK or the EU/EEA and are required to use an eligibility checker tool six weeks prior to making a full submission. The eligibility form, generated via this tool, helps determine the suitability of their Marketing Authorisation Application (MAA) and identifies the appropriate route (A or B) to follow.
For the application, all IRP submissions should be made using a consolidated electronic Common Technical Document (eCTD) sequence through the MHRA Submissions Platform. Specific UK requirements, such as pharmacovigilance and product information, must be complied with in the application.
Conclusion
The IRP, by streamlining the medicine approval process and fostering a collaborative approach with global partners, signifies the UK's adaptability and forward-thinking in the post-Brexit era. This procedure not only accelerates patient access to new treatments but also positions the UK at the forefront of medical innovation.
For more detailed information on the IRP, you can visit the MHRA’s guidance on the International Recognition Procedure.
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