On 10 October 2025 the UK Government issued an update jointly on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) on the joint regulatory and approval pathway. The news follows the launch of the Regulatory Action Plan in March 2025, and marks an unexpected acceleration of the ‘aligned pathway’ - a process designed to bring together regulatory evaluation and value assessment into a single, streamlined route.
Traditionally, the licensing process run by the MHRA and the value assessment performed by NICE have occurred consecutively, resulting in a 90-day lag between marketing authorisation and NICE guidance. Under the new scheme, these processes are handled in parallel, with both agencies’ decisions now published simultaneously. This structural change is intended to reduce delays and enable patients to access new medicines up to three months earlier.
Applications for the pathway are now being welcomed from pharmaceutical companies whose products have been designated as eligible for early access by both NICE and the MHRA. To maintain eligibility, companies are required to commit at a global level to the timelines set by the pathway. In addition, NICE is offering priority scheduling for products that opt into this process, further reducing time to evaluation and decision.
Preparatory steps include encouraging manufacturers to register new medicines on the UK PharmaScan database at least three years before marketing authorisation. Early engagement with the regulatory and assessment bodies is recommended to maximise the benefits of the streamlined approach.
A significant further enhancement will be the launch of a fully integrated joint scientific advice service, due by April 2026. This service will provide a single entry point for coordinated advice from both the MHRA and NICE and is intended to offer clarity on evidence expectations and minimise duplicative requirements.
Any companies with existing technology appraisals scheduled who believe their medicines may be suited to the aligned pathway are invited to contact the NICE scheduling team for further guidance.
The expected effect will be more rapid patient access to innovative medicines within the NHS, increased efficiency for developers, and reinforcement of the UK’s position as a competitive location for life sciences.
Source: MHRA and NICE invite early adopters to trial accelerated aligned pathway – six months ahead of schedule
Date: 10 October 2025
