The MHRA-NICE aligned pathway opens on 1st April 2026. The pathway and an improved advice service will help get new medicines to patients faster and support companies to plan with more certainty.
This follows commitments in the government’s 10 Year Health Plan for England and Lice Sciences Sector Plan for NICE and the MHRA to work more closely to get medicines to patients sooner.
Alongside the pathway, NICE and the MHRA are also launching an improved Integrated Scientific Advice service. This will offer a single-entry point, meeting and report, and one payment, while aligning data and scientific expectations where possible.
The MHRA-NICE aligned pathway overview:
Key Features:
- NICE appraisal process brought forward to align with market authorisation, resulting in same time decisions on licensing and value
Key Benefits:
- NHS and patients get medicines 3-6 months earlier
- More predictable timelines, helping forward-planning
- Commercial benefits realized sooner for industry
- NHS informed earlier, supporting efforts to speed up adoption of new medicines
Integrated scientific advice overview:
Key Features:
- A refreshed joint scientific advice service will provide independent scientific advice from MHRA and NICE through:
- Single gov.uk entry point and workflows
- Single integrated advice meeting and report
- Single payment
Key Benefits:
- Increased user confidence and clarity on evidence requirements, helping to avoid unnecessary delays and adhere to aligned pathway timings
- Independence retained, yet conflicting advice avoided through MHRA-NICE alignment on relevant topics e.g. endpoints
- More reliable and predictable timelines through closer alignment of MHRA and NICE operational processes
Guidance on the pathway can be found on the below link:https://www.gov.uk/government/publications/introducing-new-medicines-in-the-nhs-in-the-uk/introducing-new-medicines-in-the-nhs-in-the-uk-pathway