New recognition routes to fast-track UK medicine access

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that new international regulatory recognition routes for medicines will be established using approvals from the EU, Switzerland, US, Canada, Australia, Singapore and Japan.

According to the MHRA, the recognition routes mark the start of a new international recognition framework for medicines that will be in place by the first quarter of 2024.

The new framework will allow the UK’s body for medicine regulation to streamline assessments of certain products, meaning cutting-edge medicines approved in other countries will get to UK patients more quickly, offering reductions in costs for industry.

New UK point of care manufacturing regulatory framework

Introducing new international regulatory recognition routes

The new routes will sit alongside the MHRA’s innovation pathway for medicines which integrates early regulatory advice with health technology assessment advice.

When the UK exited the European Union in 2020, the MHRA introduced temporary supply chain routes to market for European approved products in Great Britain. These are known as EU ‘reliance’ routes, to ensure that patients could continue to have timely access to new treatments. These temporary routes are due to expire at the end of 2023, the MHRA stated.

MHRA’s Chief Executive Dr June Raine added: “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.”

Through ILAP, the MHRA Innovation Passport was awarded to Boehringer Ingelheim’s investigational BI 907828 in November 2022, for de-differentiated liposarcoma (DDLPS). This is a rare tumoural cancer which has not seen new first-line treatment in over forty years. Read the article on Boehringer Ingelheim’s ILAP designation here.

In March 2023, the HM Treasury announced a total of £10 million was awarded to the MHRA, to support development of the new recognition framework. This will help bring innovative new medicines such as cancer vaccines and AI-based therapeutics for mental ill-health to UK patients more quickly.