New drugs could get “near automatic” sign off for use in the UK under plans to enter new partnerships with other international drugs regulators.
Chancellor Jeremy Hunt announced that £10 million is to be given to the UK regulator – the Medicines and Healthcare products Regulatory Agency (MHRA) – to help streamline approvals for new medical products.
Under the plans, drugs which have already been approved by “trusted regulators” could be given the green light for UK use in an expedited way.
The first regulatory partners MHRA intends to build new “recognition routes” with are agencies in the USA and Japan, it said.
The MHRA said it will still be responsible for the approval of all “recognition route applications”.
We greatly welcome the £10 million funding 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.— Dr June Raine, MHRA chief executive
The money, announced in the Spring Budget, will also be used to be used to develop a “thorough but shortened process to speed up the approval process for cutting-edge treatments developed in the UK”, the MHRA said.
In his Budget speech, Mr Hunt said: “We are lucky with the MHRA to have one of the most respected drugs regulators in the world, indeed the very first to licence a Covid vaccine.
“From 2024, they will move to a different model which will allow rapid, often near automatic sign-off for medicines and technologies already approved by trusted regulators in other parts of the world such as the United States, Europe or Japan.
“At the same time from next year they will set up a swift new approval process for the most cutting-edge medicines and devices to ensure the UK becomes a global centre for their development.
“And with an extra £10m of funding over the next two years they will put in place the quickest, simplest, regulatory approval in the world for companies seeking rapid market access.”
Commenting on the announcement, Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry (APBI), said: “The Chancellor has announced welcome support for the MHRA.
“An increase in long-term funding, measures to speed up approvals for new medicines, and a commitment to increase collaboration with global regulators will all support pharmaceutical companies bringing new medicines to UK patients.”
Before Brexit, the UK was a member of the European Medicines Agency (EMA) which meant that drugs approved in Europe could be quickly available in the UK.
Alison Dennis, life sciences expert at international law firm Taylor Wessing, said: “The MHRA has had to recognise that outside the EU, the UK is a relatively small market and for which a separate regulatory system would be a barrier to placing medicines and devices on the market.
“By recognising other authorities’ decisions (both for medicines and devices), the MHRA can ensure that regulation is not a barrier to market entry into the UK.”
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.”
Health Secretary Steve Barclay added: “This new funding will accelerate the delivery of cutting-edge treatments like including 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.”
Commenting on the announcement, Sir Martin Landray, professor of medicine and epidemiology at the University of Oxford, said: “I am very pleased to see the MHRA given the additional resource it needs to attract, retain and develop the expertise it needs.
“With respect to timely approval of treatments that have undergone approval by other regulators – the UK is a small market for new products and consequently of lower priority for developers than many other territories, including USA, EU and Japan.
“The job of the MHRA is to assess the safety and efficacy of medicines.
“There are very few issues that are so specific to the UK that they require special assessment.
“So a default position of adopting an approval that has been issued by another sophisticated regulator such as US FDA or European Medicines Agency makes sense – and frees up resource to focus on medicines that have particular scientific or clinical issues or where approvals in other countries seem inappropriately slow for non-scientific reasons.”
