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New recognition routes for drugs approved outside the UK will come into place in the first three months of 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) has said.
Medicines approved by regulators in Australia, Canada, Japan, Switzerland, Singapore and the United States will be added to those given marketing authority in Europe by the European Medicines Agency (EMA), making them eligible for the faster MHRA approval route.
Since the UK left the European Union in January 2020, the MHRA’s European Commission Decision Reliance Procedure has allowed companies to apply immediately for a marketing authorisation in Great Britain on receipt of a positive opinion from the EMA’s Committee for Medicinal Products for Human Use.
The fast-track mechanism to GB approval was intended to last for two years after Brexit, but was extended in January 2023 for another year. EMA decisions have continued to apply in Northern Ireland.
The new, extended, scheme will begin before the existing European scheme expires.
Announcing the new approvals system in a statement on 26 May 2023, the MHRA said the recognition routes had been facilitated by existing international partnerships, such as those developed through the Access Consortium and Project Orbis.
“The new framework will allow the MHRA to make the most of the expertise and decision-making of trusted regulatory partners to streamline assessments of specific products,” the statement said.
Chancellor Jeremy Hunt announced £10m of funding for the new system as part of the spring budget in March 2023, saying at the time that the MHRA’s model for approving medicines would allow “rapid, often near automatic sign-off” for those already approved by regulators in some other parts of the world.
Announcing the finalisation of the scheme on 26 May 2023, June Raine, chief executive of the MHRA, said: “We are focused on providing UK patients faster access to the absolute best, most cutting-edge, and safest medical treatments. By fast-tracking access to approved products from other countries, we’re ensuring that innovative healthcare solutions reach those in need without delay.
“The introduction of the new routes will complement the work being done through the MHRA’s Innovative Licensing and Access Pathway (ILAP), establishing an additional avenue for accelerated access to life-saving new medicines. Combining MHRA’s globally recognised high standards with improved flexibility and a sustained collaborative approach across the healthcare system, the ILAP is helping reduce the time to market for innovative treatments by developing medicines that are both regulatory and access ready.
Commenting on the announcement, Claire Machin, executive director international policy and UK competitiveness at the Association of the British Pharmaceutical Industry, said: “This announcement confirms the countries which will be included in the MHRA’s new international recognition framework and marks an important step forward for this promising initiative, which we hope will contribute to faster access to new medicines for UK patients.
“Life science companies now await further essential detail around the timeline and operational aspects to inform their regulatory planning and decisions for 2024 and beyond.”
