The MHRA and the National Institute for Health and Care Excellence (NICE) have launched an aligned pathway.
This is a joint initiative designed to streamline the scheduling of the regulatory approval and health technology assessment processes in order to reduce the time before a new medicine is available on the NHS following the grant of the marketing authorisation (MA).1
Essentially, it will allow the simultaneous publishing of the regulatory and health technology assessment decisions.
What is the simultaneous publishing of regulatory and health technology assessment decisions expected to achieve?
The simultaneous publishing of regulatory and health technology assessment decisions is expected reduce the the 90-day gap between marketing authorisation and NICE guidance decisions, meaning faster patient access, support for the NHS and a more efficient route for industry.
NICE appraisal committee meetings will now be able to take place in public before marketing authorisation.
- NICE can also publish both draft guidance and final draft guidance before the MHRA decision – with the caveat that recommendations are subject to marketing approval.
- This represents a significant shift in how NICE coordinates its activities.
When was the aligned pathway announced?
The aligned pathway was announced by the UK MHRA and the National Institute for Health and Care Excellence (NICE) in August 2025 following the publication of the Regulatory Action Plan from HM Treasury in March 2025.
Which companies can take advantage of the aligned pathway?
Pharmaceutical companies which make qualifying medicines can now take advantage of a streamlined approvals pathway for medicines much earlier than anticipated.
Will all medicines be suitable for the aligned pathway?
It is recognised recognise that not all medicines will be suitable for the aligned pathway.
- Some complex topics may require alternate scheduling, where NICE will not progress to committee until marketing authorisation is granted.
- This ensures that NICE maintain its rigorous evaluation standards while providing flexibility for more challenging assessments.
- For companies that cannot meet NICE submission timelines which puts the start of their NICE evaluation before marketing authorisation, NICE will publish a deferral.
- This will provide complete transparency on when NICE will evaluate a medicine following marketing authorisation.
Is the aligned pathway optional?
Yes, the aligned pathway is entirely optional, giving companies full control over their submission strategy.
- Companies can choose to request a later submission date, following the traditional sequential approach.
- This flexibility is particularly valuable for companies whose global development programmes or regulatory timelines do not currently align with the earlier submission requirements.
Early access to the aligned pathway for some pharmaceutical companies
- The MHRA and National Institute for Health and Care Excellence (NICE) are now offering some pharmaceutical companies early access to the aligned pathway six months earlier than projected, as user research begins to shape the next phase of the programme.
- The pathway is now accepting applications from manufacturers who make medicines which have been designated by the NICE and the MHRA for early access.
Will there be a joint scientific advice service to complement the aligned pathway?
- A new fully integrated joint scientific advice service, launching by April 2026, will provide a single-entry point for coordinated advice from the MHRA and NICE to help avoid delays and support alignment.
- The service is designed to help companies successfully adhere to aligned pathway timelines, providing enhanced clarity and confidence in investment decisions by providing evidence requirements early and avoiding unnecessary delays.
What’s required from pharmaceutical companies?
To facilitate these changes:
- Pharmaceutical companies are encouraged to register products on UK PharmaScan at least three years before marketing authorisation and to engage early with both organisations.
- Companies will also need to commit (at global level) to adhering to the timelines.
- To support this approach, NICE will offer priority scheduling, ensuring these medicines can progress through its evaluation process in time to achieve simultaneous publication with regulatory decisions.
What action should companies with a technology appraisal already scheduled who believe their product may be suitable for the aligned pathway take?
Any companies with a technology appraisal already scheduled who believe their product may be suitable for the aligned pathway should contact the NICE scheduling team – scheduling@nice.org.uk.
How will independence and transparency of the MHRA and NICE be maintained via the aligned pathway?
A crucial factor underpinning the entire approach is that NICE and MHRA will continue to operate independently, maintaining their distinct evaluation standards.
- While timelines will be aligned and information sharing improved, each organisation will continue to retain its own rigorous assessment criteria and decision-making processes.
- MHRA will continue to focus on safety, quality and efficacy for regulatory approval, while NICE will continue to maintain its established framework for evaluating clinical and cost effectiveness.
- NICE also remains committed to maintaining its public committee meetings and transparency standards.
How does the aligned pathway deliver on UK government ambitions?
The aligned pathway delivers on government ambitions in the Regulatory Action Plan, 10-Year Health Plan for England and the Life Sciences Sector Plan by:
- streamlining regulation
- accelerating access to medicines for patients and the NHS, and
- improving the UK’s global competitiveness in life sciences.
References
1. MHRA and NICE launch aligned approvals pathway, 15 October 2025, Adela Williams et al Bioslice Blog, Arnold & Porter