MHRA-NICE aligned pathway: faster access to medicines in the NHS
A new aligned pathway between MHRA and NICE aims to accelerate patient access to medicines by synchronising regulatory approval and health technology assessment timelines.
Introduction
A new aligned pathway between the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) has been introduced to support faster patient access to new medicines in the NHS. The pathway enables medicines to reach patients 3 to 6 months sooner by aligning regulatory and health technology assessment decisions.
What is the MHRA-NICE aligned pathway?
The aligned pathway brings NICE’s decision-making process forward so that it runs alongside MHRA marketing authorisation. This allows regulatory approval and NICE technology appraisal guidance to be delivered at the same time.
Participation in the pathway is optional, and both organisations continue to operate independently, maintaining their own evaluation standards.
Key benefits of the aligned pathway
Earlier NHS access to medicines
NICE guidance can be published at the same time as MHRA marketing authorisation, enabling earlier availability of medicines within the NHS.
Improved predictability for companies
Coordinated milestones and priority scheduling from NICE provide more predictable timelines for planning submissions and market entry.
Commercial and system benefits
Earlier NHS entry allows companies to realise commercial benefits sooner and extend the period before pricing scheme rebates apply. The pathway also aims to support faster NHS adoption of new medicines over time.
Who can use the pathway?
The aligned pathway is open to all therapeutic areas, with no limit on the number of participating companies.
Medicines entering through existing routes such as the Innovative Licensing and Access Pathway (ILAP), national licensing route, ACCESS consortium or Project Orbis may be prioritised for scheduling.
How the aligned pathway works
Step 1: Register on UK PharmaScan
Companies must register their medicine on UK PharmaScan at least three years before expected MHRA marketing authorisation. This is a mandatory requirement.
Step 2: Confirm commitment to timelines
At the NICE topic selection stage, companies confirm their ability to meet optimal timelines. NICE then provides coordinated milestones aligned with expected marketing authorisation.
Step 3: Submit to MHRA and NICE
Submissions are made to both organisations, which independently assess the evidence. For optimal timelines, submission to NICE should occur around seven months before expected MHRA authorisation.
Step 4: Receive aligned decisions
NICE schedules appraisal activity so that draft and final guidance align with MHRA approval. Final NICE guidance is published at the same time as marketing authorisation.
Role of integrated scientific advice
Although not mandatory, integrated scientific advice from MHRA and NICE is strongly recommended. Early advice, particularly during clinical trial design, can help ensure that evidence meets both regulatory and health technology assessment requirements, supporting adherence to aligned timelines.
Conclusion
The MHRA-NICE aligned pathway represents a coordinated approach to medicines regulation and evaluation, designed to reduce delays between approval and NHS access. By aligning regulatory and NICE decisions, the pathway aims to deliver faster access to new treatments, improve planning certainty for companies, and support more efficient adoption of medicines within the NHS.
Citation
Recent Resources
