MHRA Grants First Approval through International Recognition Procedure

In a stride towards expediting patient access to medical treatments, the MHRA announced the authorisation of a new formulation for XGEVA (denosumab) via the International Recognition Procedure (IRP) on the 29th of February 2024. The approval, granted within a 30-day timeframe, marks a milestone in accelerating the availability of essential medications for UK patients.

Launched in January 2024, the IRP aims to facilitate the swifter introduction of life-saving medicines by leveraging the expertise and decisions of trusted regulatory partners worldwide. By recognising medications approved by international regulators, the IRP ensures a streamlined, efficient, and cost-effective pathway for pharmaceutical companies to bring their products to UK patients promptly.

The approval process for XGEVA under IRP was expedited following a positive initial review by the European Medicines Agency (EMA) and opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on January 25, 2024. The MHRA’s assessment, complemented by the European regulator’s review, was quick compared to standard timelines for new national MAAs/line extensions.

Under the IRP framework, applicants with prior authorisations from specified trusted reference regulators (RR), including those from Australia, Canada, the European Union, Japan, Switzerland, Singapore, and the United States, can seek approval from the MHRA. The MHRA, as the sovereign regulator, retains ultimate authority to accept or reject IRP applications, ensuring adherence to safety, quality, and effectiveness standards in licensing medications for the UK market. We are yet to see a product approved by the MHRA using a RR outside of the EU. It will be interesting to see if this introduces any disparities or challenges in the approval process compared to what we have seen so far using the EU as the RR.

Lauren Foster
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