The MHRA is set to have a ‘fully operational swift approval process for the most impactful new medicines and technologies’ in place from 2024. The funding is also designed to support the establishment of an international recognition framework: allowing it to fast-track medicines that have already been approved in other countries.
Funding will help MHRA ‘maximize Brexit freedoms’
In November, the government asked Sir Patrick Vallance, its chief scientific advisor, to lead a ‘Pro-innovation Regulation of Technologies Review’.
“Based on interim recommendations from Sir Patrick’s regulatory review of life sciences, the government is supporting the Medicines and Healthcare products Regulatory Agency (MHRA), the first drugs regulator in the world to authorize a COVID-19 vaccine, to become faster and nimbler,” said the government as it published the Spring Budget yesterday (15 March).
“With £10m extra funding over the next 2 years, the MHRA will maximize its use of Brexit freedoms and accelerate patient access to treatments.
“The MHRA is exploring partnerships with trusted international agencies, such as in the US, Europe and Japan, to provide simple, rapid approvals for medicines and technologies that have received their approval from 2024.
“The MHRA will also have a fully operational swift approval process in place from 2024 for the most impactful new medicines and technologies – such as cancer vaccines and AI therapeutics for mental health.”
The first regulatory partners that the MHRA intends to build new recognition routes with are the US Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
These will build on pre-existing international partnerships developed through the Access Consortium (comprised the national regulatory authorities of Australia, Canada, Singapore and Switzerland) and Project Orbis (a program to review and approve promising cancer drugs led by the FDA and involving also involving regulators in Australia, Canada, Singapore, Switzerland and Brazil).
Dr June Raine, MHRA Chief Executive, said: “We greatly welcome the £10m funding announced by HM Treasury, 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.”