The IRP will bring life-saving medicines to UK patients from 1 January 2024
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the launch of an online Eligibility Checker tool as part of the agency’s new International Recognition Procedure (IRP).
The IRP will allow the agency to help bring life-saving medicines to patients in the UK from 1 January 2024, following the UK’s exit from the EU.
Published in August 2023, the IRP was created to initiate a new international recognition route for medicines that utilise pre-existing approvals from Canada, Australia, the EU, Japan, Switzerland and the US.
From 2024 onwards, international recognition will sit alongside the MHRA’s current national procedures.
The new tool will allow the MHRA to consider the expertise of trusted regulatory partners in other countries when authorising medicines.
Julian Beach, MHRA interim executive director of healthcare quality and access, said: “Our new online Eligibility Checker tool has been tailored to facilitate a smooth and efficient process for marketing authorisation applicants.
“From today, we encourage applicants to begin to use the tool in readiness for making submissions via the IRP from 1 January 2024.
“Once IRP is fully up-and-running in January, we will have created a further route for bringing new medicines to UK patients.”
The launch is supported by £10m in funding from HM Treasury in March to support the development of the new recognition framework.
The funding will be used to accelerate routes for bringing innovative medical products developed in the UK onto the market, as well as those made and approved by other trusted global regulatory partners.
Steve Barclay, secretary of state for health and social care, said that the funding “will accelerate the delivery of cutting-edge treatments like cancer vaccines and new artificial intelligence technology” and will “continue to provide the best, most innovative and safest treatments in the UK”.
