The MHRA and the National Institute for Health and Care Excellence (NICE) have launched an aligned pathway to publish regulatory and health technology assessment decisions simultaneously.
What is the publishing of regulatory and health technology assessment decisions simultaneously expected to achieve?
The publishing of regulatory and health technology assessment decisions simultaneously is expected reduce the gap between MHRA licensing and NICE guidance decisions, meaning faster patient access, support for the NHS and a more efficient route for industry.
How will the gap between MHRA licensing and NICE decisions be reduced?
- The pathway brings together the MHRA’s licensing process and NICE’s value assessment process, meaning decisions will be published at the same time, instead of consecutively.
- This will reduce 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.
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.
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.
Pharma companies encouraged to register products early on UK PharmaScan and engage with the MHRA and NICE
Pharmaceutical companies are encouraged to register products on UK PharmaScan at least three years before marketing authorisation and to engage early with both organisations.
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 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.
Source: MHRA