Pharmaceutical companies producing qualifying medicines can now benefit from an accelerated approvals pathway, gaining access significantly earlier than initially expected.
The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) are offering early access to the aligned pathway six months ahead of schedule, as initial user research helps shape the programme’s next phase. Manufacturers whose medicines have received early access designation from NICE and the MHRA can now submit applications to the pathway.
Designed to support the government’s Regulatory Action Plan, the 10-Year Health Plan for England, and the Life Sciences Sector Plan, the aligned pathway integrates regulatory processes to speed up patient access and enhance the UK’s global competitiveness in life sciences. The pathway brings together the MHRA’s licensing process and NICE’s value assessment so that decisions come out at the same time, instead of one after the other. This cuts the 90-day gap between marketing authorisation and NICE guidance, giving patients quicker access, helping the NHS, and creating a smoother process for the industry.
A fully integrated joint scientific advice service will launch by April 2026, providing a single entry point for coordinated guidance from both organisations. It is designed to help companies prevent delays, get clarity on evidence requirements early, and keep to the pathway timelines. It also aims to give firms more confidence in their investment decisions.
Pharmaceutical companies are encouraged to register products on UK PharmaScan at least three years before they seek marketing authorisation and to engage early with both the MHRA and NICE. Both organisations remain committed to working closely together to improve efficiency, transparency, and timely access to innovative treatments.
The aligned pathway, which MHRA and NICE announced in July 2025 after the Regulatory Action Plan was published by HMT in March, asks companies to commit globally to its timelines. NICE will prioritise scheduling for medicinal topics on the pathway, so evaluations and regulatory decisions are published at the same time.
