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From 1 January 2024, developers of new medicines can now submit applications via the MHRA’s new, International Recognition Procedure (IRP).
The IRP will help bring life-saving medicines to UK patients and has been developed by the MHRA following the UK’s departure from the European Union. It allows the Agency to take into account the expertise of trusted regulatory partners in other countries when authorising medicines.
As a sovereign regulator, the MHRA retains ultimate authority to accept or reject applications submitted under the IRP – but the shared, global expertise inherent in the IRP process is designed to result in a more rapid, efficient, and cost-effective process for applicants.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said: With this new application procedure fully live, we are delighted to have created a further, innovative route for bringing new medicines to UK patients.
IRP allows us to access the expertise of trusted regulatory partners, who have already authorised products. In return, our partners can consider applications based on MHRA authorisations, creating a ‘win-win’ for regulators, developers of innovative treatments, and patients.
Health Minister, Andrew Stephenson, said: This announcement shows how organisations can maximise Brexit freedoms, accelerating patient access to new medicines on the NHS and putting the UK on the forefront of medical innovation. We’re making it easier than ever for patients to receive the life-saving medicines they may need, faster. This new international recognition procedure will speed up the licensing process by allowing access to the expertise of other trusted regulatory partners, including those in Australia, Canada and Switzerland.
At launch, the MHRA will partner with regulators in Australia, Canada, Japan, Singapore, Switzerland and the USA, as well as the European Medicines Agency, individual EU member states and those in the EEA (European Economic Area).
Applications under IRP can be received via the MHRA website under one of two recognised routes. Time horizons for authorisations are set at 60 to 110 days – considerably shorter than the current 150-day time horizon for applications.
To further streamline the IRP application process, the MHRA launched an ‘Eligibility Checker’ tool on 20 November 2023. Six weeks prior to making a full submission under IRP, applicants should use this tool to determine whether their Marketing Authorisation Application (MAA) is suitable and to identify which route (A or B) to follow.