The Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) are offering access to their aligned pathway six months earlier than expected.

The pathway brings together the MHRA's licensing process and NICE's value assessment process, meaning decisions will be published at the same time, instead of consecutively to reduce the 90-day gap between marketing authorisation and NICE guidance decisions, meaning faster patient access, support for the NHS and a more efficient route for industry. 

A new fully integrated joint scientific advice service, launching by April 2026, will provide a single-entry point for coordinated advice from the MHRA and NICE to help avoid delays and support alignment.

Pharmaceutical companies are invited to register products on UK PharmaScan at least three years before marketing authorisation and to engage early with both organisations. 

The aligned pathway delivers on Government ambitions in the Regulatory Action Plan, 10-Year Health Plan for England and the Life Sciences Sector Plan by streamlining regulation, accelerating access to medicines for patients and the NHS, and improving the UK's global competitiveness in life sciences.