MHRA and NICE roll out new joint pathways to accelerate access to new medicines

The new MHRA–NICE aligned pathway and integrated advice service from the UK’s regulatory and HTA bodies aim to enable parallel decision-making, supporting earlier NHS access and more coordinated evidence generation across the medicines lifecycle.

The Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) have announced that their new aligned pathway and Integrated Scientific Advice service are now fully operational, marking a significant step toward closer coordination between regulatory approval and health technology assessment (HTA) in England.

Launched on April 1, 2026, the MHRA–NICE aligned pathway is designed to enable the parallel delivery of marketing authorization and NICE technology appraisal guidance. By aligning timelines and processes across both organizations, the initiative aims to reduce the gap between regulatory approval and patient access within the NHS.

The move reflects broader policy commitments set out in the UK government’s 10 Year Health Plan for England and the Life Sciences Sector Plan, both of which emphasize the need for more integrated approaches across regulatory and reimbursement decision-making.

Under the new pathway, companies can receive NICE guidance at the same time as MHRA approval, enabling earlier entry into the NHS. The approach is supported by coordinated milestones and priority scheduling from NICE, offering greater predictability for developers and facilitating forward planning across clinical, regulatory, and market access functions. Earlier market entry may also allow companies to realize commercial benefits sooner, including extended periods before the application of Voluntary Scheme for Branded Medicines Pricing Access and Growth rebates.

The pathway is open to all therapeutic areas and does not impose limits on participation. Products progressing through existing routes such as the Innovative Licensing and Access Pathway, the national licensing route, the ACCESS Consortium, or Project Orbis will be prioritized for inclusion. However, participation remains optional, allowing companies to retain flexibility where global development timelines or submission strategies are not compatible with the aligned approach.

Initial industry engagement has been strong. In October 2025, 27 pharmaceutical companies registered as early adopters, and the first products are currently progressing through the pathway, with initial NICE guidance expected from June 2026.

Alongside the aligned pathway, the new Integrated Scientific Advice service introduces a more streamlined mechanism for early engagement with both agencies. Replacing the previous joint advice model, the service offers a single point of entry, one integrated meeting, one consolidated report, and a single fee. By bringing together regulatory and HTA evidence requirements at an earlier stage, the service is intended to support more efficient clinical development planning and reduce the risk of misalignment later in the process. Fees have also been reduced, with costs approximately 25% lower than the previous model and further reductions available for small and medium-sized enterprises.

Beyond improving timelines, the initiative is also positioned as part of a broader effort to strengthen the UK’s life sciences ecosystem. Professor Jonathan Benger, Chief Executive of NICE, noted that “by working more closely with our partners at the MHRA, we can get medicines into the NHS faster, helping to improve peoples’ health, ease pressure on NHS services and support a strong life sciences industry in this country.” Lawrence Tallon, Chief Executive of the MHRA, added that “our continued collaboration also makes the UK an even more attractive launch market for the global life sciences industry so will boost R&D investment and economic growth in this country.”

The launch of both initiatives was formally announced at the NICE Conference in Manchester and further outlined in a joint webinar held on March 25, 2026 attended by more than 2300 participants.