MHRA and NICE open accelerated drug approvals pathway six months early

Pharmaceutical companies developing qualifying medicines can now apply for early access to the UK’s new aligned regulatory pathway, six months ahead of schedule.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have begun trialling the system with early adopters, bringing together the licensing and value assessment processes to speed up access to new medicines.

The scheme also allows the MHRA and NICE to issue decisions at the same time, removing the typical 90-day delay between authorisation and NHS use.

A fully integrated joint scientific advice service is also due to launch by April 2026. This will provide a single entry point for coordinated advice from both agencies, giving companies earlier clarity on evidence expectations and helping to keep development on track.

The aligned pathway initiative is part of the government’s broader ambitions set out in its regulatory action plan, the 10-year health plan for England and the life sciences sector plan.

It aims to support NHS access to innovation, boost UK competitiveness in life sciences, and attract investment by offering faster, more predictable market routes.

Pharmaceutical companies are encouraged to register products on UK PharmaScan at least three years before marketing authorisation and to engage early with both the MHRA and NICE.