The UK’s medicines regulator initiated the International Recognition Procedure (IRP) to streamline the authorization of new drugs, accelerating access for patients within the UK. Effective from January 1st, this framework allows the MHRA to leverage expertise from trusted global regulatory partners, expediting the review of medicines already approved in other countries.
Replacing the European Commission’s centralized procedure after the UK departs from the EU, the International Recognition Procedure facilitates information exchange with regulatory bodies in the EU, US, Japan, Australia, Canada, Switzerland, and Singapore. Julian Beach, the MHRA’s interim executive director of healthcare quality and access, emphasized its benefits for regulators, drug developers, and patients, terming it a “win-win” situation.
MHRA’s International Recognition Procedure: A Multinational Regulatory Exchange
While stressing the MHRA’s ultimate authority over application acceptance or rejection, the agency outlined two IRP routes: A and B, with respective review times set at 60 and 110 days, significantly shorter than the previous 150-day target.
The Association of the British Pharmaceutical Industry (ABPI) lauded the IRP’s introduction, noting the regulatory flexibilities it introduces for companies seeking UK market entry. However, they highlighted that most innovative products would fall under category B, which might have reviews paused using a ‘clock stop.’ ABPI suggested that the new system may not be as competitive as the national procedure or as favorable as the previous European procedure.
Initiative to Expedite Patient Access to New Medicines
Health Minister Andrew Stephenson lauded the announcement, stating that it optimizes Brexit freedoms, hastening patient access to new NHS medicines and positioning the UK at the forefront of medical innovation. Stephenson emphasized the initiative’s aim to expedite life-saving medicine availability for patients.
The MHRA introduced an Eligibility Checker tool in November to aid drugmakers in navigating the new pathway. Companies should use this tool six weeks before applying for the International Recognition Procedure, determining its suitability and the appropriate route to follow.
Resource: Pharmaphorum, January 03, 2023
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