Medicines Healthcare Products Regulatory Agency
A total of 10 million has been awarded to the Medicines and Healthcare products Regulatory Agency (MHRA) to help bring innovative new medicines and medical technologies to UK patients more quickly, HM Treasury has announced today. 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 regulatory partners globally.
The funding over the next two years will support development of a thorough but shortened process to speed up the approval process for cutting-edge treatments developed in the UK with the greatest opportunity to meet the UKs healthcare priorities, such as cancer vaccines and AI-based therapeutics for mental ill-health.
It will also support the establishment of an international recognition framework, allowing the MHRA to?capitalise on the expertise and decision-making of trusted regulatory partners and provide patients?with fast-track access to best-in-class medical products that have been approved in other countries.
The MHRA will still be responsible for the approval of all recognition route applications, ensuring that all products are of sufficient quality to be licensed in the UK and it will operate a robust process promoting patient safety and access to improve the health of the UK population.
Using the Agencys pre-existing international partnerships developed through the Access Consortium and Project Orbis, the first regulatory partners that the MHRA intends to build new recognition routes with are the FDA, in the USA, and with the PMDA, in Japan.
Dr June Raine, MHRA Chief Executive, said:
We greatly welcome the 10 million funding announced by HM Treasury today, which will be used to fund our ongoing innovation work and to accelerate the development of ground-breaking global recognition routes, which will give UK patients faster access to the most cutting-edge medical products in the world.
This cash injection will ensure that we have access to the best resources, talent, and infrastructure to deliver this ambitious vision for patients across the UK.
Steve Barclay, Secretary of State for Health and Social Care, said:
Technology is transforming our care for patients, delivering faster and more accurate diagnoses. This new funding will accelerate the delivery of cutting-edge treatments like cancer vaccines and new artificial intelligence technology that will make therapy more accessible to those who suffer from mental health conditions.
It will also fast-track access to medical products that have been approved in other countries by trusted regulatory partners, ensuring we continue to provide the best, most innovative and safest treatments in the UK.
The MHRA is a global leader in regulatory innovation. The MHRA Innovation Office was established in 2013 to provide healthcare innovators with access to world-class regulatory knowledge, expertise, and experience from within?the MHRA. The Agency is continually building new, international partnerships to ensure that innovative treatments reach patients as quickly as possible. Scientific progress has been made at the Agency through highly successful internationally collaborative schemes such as the Access Consortium, which has enabled an approval for the vision-loss medicine faricimab, and Project Orbis, from which there have been eight approvals for new cancer medicines.
Notes to Editors
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Healt