MHRA and NICE Offer Streamlined Approvals Pathway for Pharmaceutical Companies
Friday 10 October, 2025 – Pharmaceutical companies producing qualifying medicines can now take advantage of a streamlined approvals pathway, thanks to the collaborative efforts of the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE).
The aligned pathway, which combines the MHRA’s licensing process and NICE’s value assessment process, aims to accelerate patient access to medicines and improve the UK’s global competitiveness in the life sciences sector. This initiative is a significant step towards achieving government ambitions outlined in the Regulatory Action Plan, 10-Year Health Plan for England, and the Life Sciences Sector Plan.
Originally projected to launch in April 2026, the aligned pathway is now available to pharmaceutical companies six months earlier than anticipated, as user research shapes the next phase of the programme. Companies can now submit applications for medicines designated by both NICE and the MHRA for early access.
This new pathway will reduce the 90-day gap between marketing authorisation and NICE guidance decisions, resulting in faster patient access, support for the NHS, and a more efficient route for the industry. Additionally, a new fully integrated joint scientific advice service will be launched by April 2026, providing coordinated advice from the MHRA and NICE to avoid delays and support alignment.
Pharmaceutical companies are encouraged to register products on UK PharmaScan at least three years before marketing authorisation and engage early with both organisations. By committing to the aligned pathway timelines at a global level, companies can benefit from priority scheduling for medicinal topics, ensuring they can progress through the evaluation process in time for simultaneous publication with regulatory decisions.
NICE and the MHRA will continue to work closely together to improve efficiency, transparency, and timely access to innovative treatments. Companies with a technology appraisal already scheduled and believe their product may be suitable for the aligned pathway can contact the NICE scheduling team at scheduling@nice.org.uk.
For further information, the MHRA and NICE have released a joint blog post with guidance on the aligned pathway. The MHRA is responsible for regulating all medicines and medical devices in the UK, ensuring they are safe and effective. On the other hand, NICE provides guidance for health and care practitioners through a rigorous and independent assessment of complex evidence for new health technologies.
For media enquiries, please contact newscentre@mhra.gov.uk or call 020 3080 7651.
