The Medicines and Healthcare products Regulatory Agency has announced new recognition routes to facilitate safe access to new medicines.
The new routes are set to open up additional options for the MHRA to bring new medicines faster to UK patients by leveraging the expertise and decision-making of trusted regulatory partners.
New regulatory recognition routes for medicines will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States.
The new international recognition routes will sit alongside the MHRA’s own unique innovation pathway for medicines which integrates early regulatory advice with health technology assessment advice.
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.
£10 million of funding was announced earlier this year to support the development of the framework.
Dr June Raine, MHRA chief executive, 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.
"Through this new dual approach, we will contribute to the UK’s ambition to be a global science superpower, by making the UK one of the best places in the world to bring life-changing healthcare products to patients safely."
Image by Gerd Altmann from Pixabay
