Parallel decision making by MHRA and NICE
The aligned UK regulatory and Health Technology Assessment (HTA) pathway will allow for rapid patient access to the National Health Service (NHS) for new drugs.
Background
The UK government’s 10 year health plan ‘Fit for Future’ was published in July 2025 and introduces many plans to improve the NHS. Reform is required to enable these goals to be met and includes the operational reform of medicine regulation. As well as a more ‘pro-innovation’ approach, the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) will launch a ‘new joint process, supported by information sharing and joint scientific advice, that will boost the speed of decisions and cut administrative burdens for the system and industry’. This is known as the ‘aligned pathway’ and will speed up access to new medicines within the NHS.
MHRA and NICE collaboration
A joint press release from the MHRA and NICE released 6 August 2025 confirmed the plan for enhanced collaboration between the two bodies. The aligned pathway is open to all new medicines and includes:
- A refreshed integrated scientific advice service, where sponsors can receive prospective feedback on clinical study designs to help ensure the relevant data are generated during development to support successful aligned MHRA and NICE decisions.
- Information sharing between MHRA and NICE during the Marketing Authorisation application process following consent by the developer.
- Priority committee scheduling by NICE, with a commitment to, where possible, publish guidance concurrently with MHRA Marketing Authorisation approval.
Integrated Scientific Advice
The MHRA and NICE organised a webinar 1 October 2025 on ‘Aligned Decisions, Faster Patient Access’. The importance of early engagement with both bodies was confirmed, especially if the product will provide challenges to the regulations, the NHS and current care pathways. Early engagement is linked to more positive interaction between the regulator and Industry during Marketing Authorisation assessment, leading to smoother approvals, and earlier publication of NICE guidance. It is planned that the integrated advice service will include a single gov.uk entry point and a single advice report and payment. This would ensure aligned decisions and a greater technical collaboration between the MHRA and NICE. A proof of concept launch is planned for early 2026 and full launch of this integrated service in April 2026.
Information sharing
Both the MHRA and NICE use UK PharmaScan as the primary source of pipeline data. UK PharmaScan is a Department of Health and Social care database of information on potential new medicines, indications and formulations in the pharmaceutical pipeline that are likely to be available on the UK market within 3 years. UK PharmaScan is used for planning and prioritising by horizon-scanning organisations such as the NIHR Innovation Observatory, NHS England and NHS Improvement, the All Wales Therapeutics & Toxicological Centre (AWTTC), Scottish Medicines Consortium, Health Improvement Scotland and the Specialist Pharmacy Service.
The aligned pathway is not mandatory, but to ‘opt in’ developers must register with UK PharmaScan 3 years prior to expected Marketing Authorisation or at the start of Phase 3 of development and add information on the medicine, indication, formulation, clinical trial information, regulatory information and data on cost and budget impact. This allows for shared information between the MHRA and NICE and the potential for joint pipeline meetings to drive collaboration across organisations.
The MHRA and NICE have improved operational information sharing to allow for the same-time release of regulatory and HTA decisions. However, in order for this to happen, Industry opted in must commit to adhere to the aligned pathway and to the NICE timings with submission to NICE prior to the MHRA.
Priority NICE committee scheduling
There is priority committee scheduling for medicines opted in to the aligned pathway. NICE have introduced scheduling process changes so that NICE decisions are made in parallel with the MHRA Marketing Authorisation assessment, which is currently 90 days following the Marketing Authorisation decision. This means that the public NICE appraisal committee meeting is held, and the draft guidance is published, before the Marketing Authorisation is granted. If this is not possible, as part of improved transparency, NICE will issue deferral publications to provide clarity on when a medicine, which has received Marketing Authorisation, will be evaluated by NICE.
Conclusion
The MHRA and NICE hope that the aligned pathway will provide earlier access to new medicines for patients with earlier system readiness within the NHS. Industry should benefit from receiving stronger signals of approvals earlier in the process and commercial benefits from reaching the NHS sooner after Marketing Authorisation.
Any questions?
If you have any questions on this topic or want to reach out regarding any aspect of your own regulatory programme, please don’t hesitate to get in touch. You can contact us through our via email (info@s-cubed.co.uk), or by telephone (S-cubed Ltd: +44 1235 77 22 60).
How can S-cubed help you?
Our Regulatory Affairs team have extensive regulatory expertise encompassing Scientific Advice and Agency meetings for new chemical, biological and ATMP entities. Why not get in touch to see how we can help you?