MHRA And NICE Launch Aligned Approvals Pathway

On 10 October 2025, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) announced the early launch of the "Aligned Pathway". This is a joint initiative designed to streamline the scheduling of the regulatory approval and health technology assessment processes in order to reduce the time before a new medicine is available on the NHS following the grant of the marketing authorisation (MA). The pathway supports the UK Government's ambitions outlined in the 10-Year Health Plan for England and the Life Sciences Sector Plan to accelerate access to medicines and reduce regulatory burden, as discussed in our blog here.

What is the Aligned Pathway?

The Aligned Pathway integrates MHRA's licensing process with NICE's health technology appraisal procedures, enabling simultaneous publication of decisions on marketing authorisation and cost-effectiveness, while preserving independent assessment and decision-making by both bodies. This marks a significant departure from the current system, whereby decisions are published consecutively and which typically involves at least a 90-day gap between MHRA approval and NICE guidance. By eliminating this delay, the Aligned Pathway is expected to accelerate patient access to innovative treatments by 3 to 6 months.

The effect of a positive NICE recommendation is that NHS commissioners in England are legally required to make funding available to cover use of the medicine as a treatment option for the recommended patient population. The funding must typically be made available within three months of publication of the final guidance. It is not intended that this standard implementation period will be altered under the Aligned Pathway.

Key features of the Aligned Pathway include:

• Joint scientific advice service: This "fully-integrated" service will offer a single-entry point for coordinated advice from both MHRA and NICE, helping companies align evidence requirements early, adhere to timings and avoid delays.
• Parallel decision-making: NICE will now be able to publish draft and final guidance before the MHRA's MA decision, with recommendations contingent on regulatory approval.
• Public appraisal meetings: NICE appraisal committee meetings may now take place in public before grant of MA .
• Priority scheduling: NICE will offer priority scheduling of medicines progressing through the Aligned Pathway, so that appraisal of these medicines can be completed in time to achieve simultaneous publication with regulatory decisions.
• Optional participation: Companies can choose to follow the standard approach and request a later submission date. This will be published as a "deferral" on NICE's website.

To be eligible for the Aligned Pathway, pharmaceutical companies must:

1. Make a "qualifying medicine" i.e. a medicine that has been designated by MHRA and NICE as suitable for early access. However, innovative medicines requiring complex assessments may not be suitable.
2. Register products on UK PharmaScan at least three years before expected MA.
3. Engage early with both MHRA and NICE.
4. Commit to Aligned Pathway timelines at a global level, although these have yet to be set out.

Next Steps

NICE is currently scheduling medicines to participate in the Aligned Pathway and together with MHRA, will be conducting user research to refine and improve the process. Any pharmaceutical companies that already has a scheduled NICE technology appraisal for a qualifying medicine, or is awaiting an appraisal and believes it qualifies for the pathway, may contact NICE's scheduling team if it wishes to participate. The Aligned Pathway and joint scientific advice service are expected to fully launch in April 2026.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.