MHRA and NICE launch Accelerated Aligned Pathway for medicines addressing unmet clinical needs in UK

The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have announced the early launch of the Accelerated Aligned Pathway, designed to streamline the process for bringing innovative medicines to NHS patients.

The regulatory bodies are inviting pharmaceutical companies that make certain medicines to apply for the new pathway, an opportunity to gain faster approvals and shape how the pathway will operate in future. 

The announcement is part of delivery of the Life Sciences Sector Plan and the early launch of the scheme (which was scheduled for April 2026) will be seen as a positive step in addressing perceived issues over medicine access in the UK. It comes against a backdrop of heated discussions between industry and government over the UK’s medicine pricing schemes. 

The Accelerated Aligned Pathway is a new, voluntary route for medicines that have the potential to address unmet clinical needs. It enables MHRA and NICE to work in parallel, so that regulatory approval and health technology assessment can be delivered at the same time, rather than being done sequentially. This means that, for products that have been designated as suitable for early access, the time between licensing and patient access to medicines could be reduced by three to six months. 

Key features include:

• Parallel assessment: MHRA and NICE will coordinate their processes, aiming to publish regulatory and value decisions simultaneously.
• Early engagement: Companies are encouraged to register products on UK PharmaScan at least three years before marketing authorisation and to engage with both agencies early in development.

The early launch of the pathway reflects the UK government’s ambition to make the UK a global leader in life sciences and to ensure that NHS patients benefit from the latest medical innovations as quickly as possible. The pathway supports the government’s wider regulatory reform agenda and aligns with commitments in the 10-Year Health Plan, Life Sciences Sector Plan and Regulatory Action Plan.

For more information the press release can be found here.

Any companies with a technology appraisal already scheduled who believe their product may be suitable for the aligned pathway should contact NICE. 

If you would like to discuss any of the above, please contact a member of our Health, Care and Life Sciences team. 

This article was written by Rory Trust and Ryan Millett.