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In October 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) announced the launch of their ‘Aligned Pathway’. This pathway brings together the MHRA’s licensing process and NICE’s value assessment process, allowing for their decisions to be published at the same time rather than the previous 90-day gap.

The pathway was launched on the 1st October 2025 and is designed to enable same-time publication of the MHRA and NICE decisions, providing increased visibility into NICE’s evaluation timelines and supporting a smoother approval process.

Key Goals of the Aligned Pathway

Improved transparency
Increase clarity for sponsors
Speed up access for patients

Sponsors, who wish to take part, are encouraged to begin discussions with MHRA and NICE well before submitting their applications. The application process remains the same, with one submission to each body being required. Submissions must be made to NICE prior to the MHRA submission. However, there will be a single gov.uk entry point and workflows, a single integrated advice report and a single payment.

Both organisations are confident that they can manage the aligned pathway without increasing the number of topics assessed. This proactive approach allows for better planning and smoother scheduling. Although the two organisations remain separate, they are working in close alignment to streamline evaluations. Currently medical devices are not in scope for the aligned pathway.

The MHRA and NICE collaborate closely with their UK Health System Partners. In a recent webinar, ‘Aligned Decisions: Faster Patient Access’ , held on the 1st October 2025, the authorities felt that ‘By sharing regular updates and strategic insights, we support alignment with national healthcare priorities… helping to accelerate patient access’.

Sponsor Requirements for the Aligned Pathway

UK PharmaScan is the primary source of pipeline data for the MHRA and NICE. The data is owned by the inputter/industry and is accessed by the UK system horizon scanners. This helps to ensure UK system readiness. It is recommended for industry to have their innovative products on PharmaScan as early as possible – up to 3 years before marketing authorisation. This will allow the MHRA and NICE to plan resources accordingly.

Pipeline Meetings: Highlighting Transformative Products

Pipeline meetings, requested by a company, highlight transformative and impactful products and their timelines to the MHRA and NICE. The joint pipeline meetings are helping to drive collaboration across both organisations. There are 6 pipeline meetings planned with 3 already completed. These meetings will look different as they evolve.

Benefits for Sponsors, Patients and the NHS

The aligned pathway brings benefits to both sponsors and patients. For sponsors a single-entry point will allow for an easier submission process. The aim is to achieve further clarity on NICE evaluation timelines, faster publication guidance and fewer questions during the approval process. As a result, there will be increased user confidence and clarity on evidence needs due to the collaboration from the MHRA and NICE.

For patients there will be quicker access to innovative therapies and a reduction in the delays between regulatory approval and clinical use. The pathway aims to provide clarity when a press release goes out on a new innovative medicine. Currently there is often a patient expectation that the medicine will be available the next day.

For the NHS there will be earlier notice via PharmaScan which will allow for earlier system readiness. Commercial benefits can be realised quicker through reaching the NHS sooner after marketing authorisation decision.

Managing Complex Topics in the Aligned Pathway</h2>

While the new pathway aims to increase the speed of patient access, the MHRA and NICE acknowledge that there are some topics which may be too complex to assess within the specified timelines. If this occurs the MHRA and NICE will communicate when evaluations restart and topics may be redirected from public committee meetings. The MHRA and NICE will discuss complex products with the Sponsor.

Next Steps for Sponsors

The MHRA and NICE are currently inviting Sponsors to trial the accelerated aligned pathway, six months ahead of schedule. Sponsors can opt into the aligned pathway now and topics are being scheduled. NICE are open to rescheduling existing submissions but will not be proactively looking back.

To benefit from the aligned pathway, sponsors must:

Ensure PharmaScan records are current
Submit to NICE before the MHRA
Engage early with both the MHRA and NICE
Request rescheduling if submissions are already underway – over the next 6 months, MHRA and NICE will be conducting user research to help shape the final pathway, and the full launch is expected by April 2026.

Conclusion

The aligned pathway marks a major shift in how the MHRA and NICE work together in the UK. By engaging early with each other, streamlining advice services, and synchronising decisions, they are paving the way for faster patient access to innovative medicines.

To be in the best position to benefit, Sponsors should register their innovative products early, maintain accurate records on PharmaScan and embrace early engagement with the MHRA and NICE.

For patients and the NHS, this means potentially quicker access to life-changing therapies and improved system readiness, delivering better health outcomes sooner.

Ongoing feedback and collaboration will be key to the pathway’s success, and DLRC is committed to supporting sponsors through this evolving process. Contact us today at hello@dlrcgroup.com to discuss how DLRC’s award-winning consultants can help you throughout your product’s approval process.