Guidance

Get medicines to NHS patients earlier via the MHRA-NICE aligned pathway

Published 1 April 2026

1. Overview

The MHRA-NICE aligned pathway will get new medicines to patients 3 – 6 months sooner. This will be achieved by bringing the National Institute for Health and Care Excellence’s (NICE) decisions forward to align with the Medicines and Healthcare products Regulatory Agency (MHRA), resulting in delivery of regulatory and health technology assessment decisions at the same time.

Using the aligned pathway is optional. Both organisations continue to operate independently and maintain their own distinct evaluation standards.

2. Key benefits

Pharmaceutical companies using the aligned pathway can benefit from:

• Earlier NHS market access – NICE TA guidance will be published at the same time as MHRA marketing authorisation.
• Predictable timelines – priority scheduling from NICE and coordinated milestones to support forward-planning.
• Commercial benefits realised sooner due to earlier entry into the NHS and longer exclusivity before Voluntary Scheme for Branded Medicines Pricing Access and Growth (VPAG) rebates apply.
• NHS and global markets will be notified earlier. While the aligned pathway is one part of a broader ecosystem, the ambition is that over time, it will contribute to  speeding up NHS adoption of new medicines.

3. Who is the aligned pathway suitable for?

All therapeutic areas are eligible for the aligned pathway and there is no cap on the number of companies who can use it.

Topics coming through the Innovative Licensing and Access Pathway (ILAP), National licensing route, ACCESS consortium or Project Orbis pathways will be prioritised for scheduling to the MHRA-NICE aligned pathway.

4. How it works

4.1 Step 1: Register on UK PharmaScan

Register your medicine on UK PharmaScan, the national horizon scanning database, at least 3 years before your expected MHRA marketing authorisation. This is an essential requirement for joining the MHRA-NICE aligned pathway.

4.2 Step 2: Confirm your commitment

At the NICE topic selection stage, confirm to NICE that you can submit to their optimal timelines. The NICE team will then share coordinated timelines linked to your expected marketing authorisation. There is no separate application process.

4.3 Step 3: Submit to NICE and MHRA

Submit your dossiers to the MHRA and NICE. Each organisation will assess the evidence and reach its own decisions independently. For optimal timelines, submit to NICE around 7 months before your expected MHRA marketing authorisation. Depending on the MHRA route, this may mean submitting to NICE before the MHRA.

4.4 Step 4: Receive aligned decisions

For products on track with the pathway, NICE will schedule its appraisal committee meetings, draft guidance and final draft guidance to take place before your MHRA marketing authorisation is granted. Any draft guidance published before marketing authorisation will make clear that final recommendations are subject to the licence being granted. NICE will then publish its technology appraisal to coincide with your MHRA marketing authorisation.

5. Integrated scientific advice

While integrated scientific advice is not a requirement of the aligned pathway, MHRA and NICE strongly recommend it in, at minimum, the design of your pivotal clinical trials. Early scientific advice can help you design your clinical development programme to meet both regulatory and health technology appraisal requirements, helping you to adhere to aligned pathway timelines. Get integrated scientific advice from the MHRA and NICE

6. Contact us

If you have questions about the aligned pathway, contact: presubmission@mhra.gov.uk

For help with scheduling of your topics, contact: scheduling@nice.org.uk

Useful links:

Planning your technology appraisal submission to NICE