MHRA and NICE Announce Streamlined Approval Pathway for Medicines
Pharmaceutical companies can now take advantage of an aligned pathway for licensing and value assessment of qualifying medicines, thanks to the collaborative efforts of the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE). This pathway will streamline decisions on licensing and value for medicines, ultimately helping patients to benefit from them sooner.
Originally projected to launch in April 2026, the aligned pathway is now accepting applications from manufacturers who make medicines designated for early access by NICE and the MHRA. This early launch is a result of user research shaping the next phase of the programme and aligns with government ambitions in the Regulatory Action Plan, 10-Year Health Plan for England, and the Life Sciences Sector Plan. By streamlining regulation and accelerating access to medicines, the aligned pathway aims to improve the UK’s global competitiveness in life sciences.
The pathway brings together the MHRA’s licensing process and NICE’s value assessment process, allowing decisions to be published simultaneously instead of consecutively. This 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 industry.
Additionally, a new fully integrated joint scientific advice service will be launched by April 2026 to provide coordinated advice from the MHRA and NICE and avoid delays. This service aims to help companies adhere to aligned pathway timelines, providing evidence requirements early and avoiding unnecessary delays. Companies are encouraged to register products on UK PharmaScan at least three years before marketing authorisation and engage early with both organisations.
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 who believe their product may be suitable for the aligned pathway should contact the NICE scheduling team at scheduling@nice.org.uk.
For further guidance on the aligned pathway, please see the joint blog post by the MHRA and NICE. This pathway was first announced in July following the publication of the Regulatory Action Plan by HMT in March 2025. To support this approach, NICE will offer priority scheduling for medicinal topics following the aligned pathway, ensuring these medicines can progress through its evaluation process in time to achieve simultaneous publication with regulatory decisions.
The MHRA is responsible for regulating all medicines and medical devices in the UK, ensuring they are safe and effective. NICE provides useful and usable guidance for health and care practitioners, including rigorous, independent assessment of complex evidence for new health technologies. Both organisations are underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. For media enquiries, please contact newscentre@mhra.gov.uk or call 020 3080 7651.
Derick is an experienced reporter having held multiple senior roles for large publishers across Europe. Specialist subjects include small business and financial emerging markets.