The UK MHRA has announced today that new regulatory recognition routes for medicines will be established using approvals from the following countries:
- Australia
- Canada
- European Union
- Japan
- Switzerland
- Singapore
- United States
This means that patients will have access to safe and effective medicines that have been approved by trusted regulatory partners in other countries.
How have these new regulatory recognition routes been facilitated?
These recognition routes have been facilitated by existing international partnerships such as those developed via the Access Consortium and Project Orbis.
The new international recognition routes will sit alongside the MHRA’s own unique innovation pathway (ILAP) for medicines which integrates early regulatory advice with health technology assessment advice.
When will the new international recognition framework for medicines start?
A new international recognition framework for medicines that will be in place by Q1 2024
What are the expected benefits of the new framework?
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. As a result, cutting-edge medicines that have been approved in other countries will get to UK patients more quickly, with cost reductions and streamlined regulatory processes for industry.
Will the MHRA still be responsible for approving all ‘recognition route’ applications?
Yes, as a sovereign regulator, the UK regulator will still be responsible for approving all ‘recognition route’ applications under the new framework, ensuring that all products are safe and of sufficient quality to be licensed in the UK. The MHRA will maintain rigorous scrutiny and retain the authority to reject applications if the evidence provided is considered insufficiently robust.
Is there a similar plan for recognition routes for medical devices?
Yes there is.
While the international recognition routes announced today focus on medicines, work is underway to establish similar routes for medical devices. As part of this ongoing work, the MHRA will launch a new targeted consultation on medical devices that will gather views on a wide range of topics, including recognising conformity assessments or approvals from international regulatory partners.
Source: MHRA