The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have announced the early rollout of their accelerated aligned pathway for medicines launching six months sooner than originally planned. This new approach aims to streamline regulatory and value assessment processes, allowing patients to gain faster access to innovative treatments.

Under the initiative, pharmaceutical companies developing eligible medicines can now apply for entry into the aligned pathway. This joint effort supports key government strategies, including the Regulatory Action Plan, England’s 10-Year Health Plan, and the Life Sciences Sector Plan, by enhancing the UK’s global competitiveness in life sciences and strengthening access to cutting-edge therapies for both patients and the NHS.

The aligned pathway integrates MHRA’s marketing authorization process with NICE’s health technology assessment, enabling both decisions to be released simultaneously rather than in sequence. This eliminates the usual 90-day gap between regulatory approval and NICE guidance, speeding up patient access and simplifying industry procedures.

Additionally, a fully integrated joint scientific advice service is set to launch by April 2026. The service will act as a single-entry point for coordinated guidance from both agencies, ensuring companies receive early clarity on evidence requirements and can efficiently meet pathway timelines improving investment confidence and reducing delays.

Pharmaceutical manufacturers are encouraged to register their products on UK PharmaScan at least three years before seeking marketing authorisation and to initiate early engagement with both MHRA and NICE.

Both agencies confirm their commitment to closer collaboration to enhance efficiency, transparency, and timely access to innovative medicines.

Learn more: MHRA and NICE invite early adopters to trial accelerated aligned pathway – six months ahead of schedule