The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have launched the aligned pathway for new medicines, setting out how companies can coordinate marketing authorisation and technology appraisal submissions so that regulatory approval and NICE guidance are available at the same time.
The guidance, published by MHRA on 1 April 2026 and updated on 9 April with webinar material, implements a development announced earlier rather than creating a separate appraisal standard. MHRA says the pathway could bring National Health Service (NHS) access forward by three to six months. Use of the route is optional, and both organisations will continue to make independent decisions under their own assessment standards.
The pathway relies on earlier horizon-scanning and more disciplined submission timing. Companies must register their medicine on UK PharmaScan at least three years before the expected MHRA marketing authorisation. At NICE topic-selection stage, they must confirm that they can meet NICE’s optimal timelines. NICE will then share coordinated milestones linked to the expected authorisation date.
For products on track, NICE will schedule appraisal committee meetings, draft guidance and final draft guidance before MHRA grants marketing authorisation. Any draft NICE guidance issued before authorisation will remain conditional on the licence being granted. NICE will then aim to publish final technology appraisal guidance at the point of MHRA marketing authorisation.
MHRA and NICE strongly recommend integrated scientific advice, particularly for pivotal trial design, although it is not mandatory. The pathway therefore shifts part of the UK access timetable into earlier evidence planning. Its effect will depend on whether companies can align regulatory strategy, HTA evidence generation and NICE submission readiness far enough before launch.
Source: Medicines and Healthcare products Regulatory Agency
Link: Get medicines to NHS patients earlier via the MHRA-NICE aligned pathway
Date: 1 April 2026
