MHRA and NICE aligned pathway: progress update on integrated scientific advice services

Read our progress update on how the MHRA-NICE aligned pathway and integrated scientific advice services are working since launching in April 2026.

With the aligned pathway and integrated scientific advice services fully open for business since April 2026, we wanted to share an update on how things are progressing, including the latest figures on uptake, examples of closer working in action, and customer feedback.

Aligned pathway: progress so far

Since October 2025, 90 topics have been scheduled to the aligned pathway, spanning 49 therapeutic areas. This includes products from both large multinational companies and smaller and medium-sized enterprises, reflecting interest from across the sector.

We expect to see the first medicine complete its journey through the aligned pathway later this year, and we'll share more detail on this milestone as soon as we're able to.

Companies who register for the aligned pathway but later decide to defer will still benefit from greater clarity, as NICE will confirm when its evaluation will begin following marketing authorisation. This gives companies certainty over timelines even if their circumstances do not allow for an earlier submission.

The wider benefits of closer MHRA-NICE working

Although the aligned pathway is central to our work, the benefits of improved collaboration between MHRA and NICE go beyond it. A recent example is aficamten, a new daily pill for people with obstructive hypertrophic cardiomyopathy.

Although aficamten was not scheduled through the aligned pathway, NICE was still able to publish final guidance alongside the MHRA’s marketing authorisation decision, and 2 weeks faster than NICE's standard process, thanks to efficiencies gained through closer working between the 2 organisations. This means around 6,600 people in England with this serious heart condition will be able to access this new treatment sooner. And we expect to see further examples like this over the next 2 to 5 months as our operational alignment continues to mature.

This closer working is underpinned by robust data sharing agreements between the MHRA and NICE, with commercially sensitive information handled under strict confidentiality protocols throughout. Transparency remains just as important: NICE continues to hold public committee meetings, and any draft guidance published ahead of marketing authorisation clearly states that final guidance is subject to the licence being approved by the MHRA.

Integrated scientific advice: what companies are telling us

Since launching in April 2026, we've commenced 3 integrated scientific advice projects. These are designed to help companies clarify regulatory and health technology assessment evidence requirements early in their development plans, increasing the chances of meeting the requirements of the aligned pathway.

Feedback so far has been positive, with one client describing the process as ‘seamless’. We'll share more comprehensive feedback from companies as more projects are completed.