MHRA-NICE pathway opens for business – everything you need to know to get started

Today marks a significant milestone for patients, the NHS and the pharmaceutical industry. From 1 April 2026, the MHRA-NICE aligned pathway and improved Integrated Scientific Advice service are fully open for business. This follows the commitment made in the UK government's 10 Year Health Plan for England and Life Sciences Sector plan to get medicines to NHS patients sooner.

Through closer collaboration and operational alignment between NICE and the Medicines and Healthcare products Regulatory Agency (MHRA), the aligned pathway enables parallel publication of decisions on licensing and value. For industry, this means earlier NHS entry and a longer period of rebate-free sales before the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) applies. For the NHS, earlier notification supports forward planning and adoption of new medicines.

Sitting alongside the aligned pathway is our new Integrated Scientific Advice service. By clarifying regulatory and health technology assessment evidence requirements of both organisations early in the development process, companies can optimise their clinical development plans, reduce the risk of unforeseen delays, and adhere to aligned pathway timelines. Through a single GOV.UK entry point, one advice meeting, one report and one payment, the service offers a more streamlined and cohesive experience than the previous joint scientific advice service. Thanks to the efficiencies of the new workflow, fees are around 25% lower than the previous service and 40% lower for small and medium-sized enterprises.

Last week, we hosted a webinar, 'Aligned decisions, faster patient access', to explain how these services will work in practice. It attracted over 2,300 registrations and more than 150 questions, reflecting the significance of these changes to the healthcare ecosystem. In this blog, we reflect on the processes that were explained and key themes discussed.

The aligned pathway customer journey

• At least 3 years before marketing authorisation, register on UK PharmaScan and keep your details updated.

• 2 to 5 years before marketing authorisation, request Integrated Scientific Advice, ideally before finalising pivotal study plans.

• 16 to 20 months before marketing authorisation, NICE confirms optimal submission timings; topics automatically join the pathway with no separate application or additional fees.

• 8 months before marketing authorisation, health technology assessment begins.

• MHRA’s regulatory review starts once NICE’s health technology assessment is underway. Scheduling will be based on the chosen regulatory route.

• MHRA marketing authorisation and NICE guidance published simultaneously.

Early pipeline meetings with larger companies are already under way and working well. If your company would like to arrange one, please get in touch with presubmission@mhra.gov.uk. Since 1 October 2025, all topics submitted to NICE for scheduling can follow the aligned pathway, provided NICE receives timely notification.

How to access the Integrated Scientific Advice service

Visit GOV.UK to check which type of scientific advice suits your needs and submit a request form, taking around 30 to 60 minutes to complete. The enquiry stage, which involves setting a date for the advice meeting and preparing a contract, takes around 4 weeks. Following briefing book submission, the final written advice report is delivered within 18 weeks. Where relevant (for example, endpoints and patient populations) advice from both organisations will be aligned to avoid conflicting advice. Where requirements differ, the implications and practical options available to you will be clearly explained.

Companies were encouraged to get in touch with NICE Advice for an informal discussion if they are considering using the Integrated Scientific Advice service.

Same rigour, better coordination

NICE's processes are not changing. What is changing is the timing. NICE is bringing its technology appraisal process forward to align with the MHRA's, so that decisions are published simultaneously. Both organisations remain fully independent, with rigorous evaluation standards preserved.

Confidentiality and transparency – getting the balance right

Robust data sharing agreements are in place between NICE and the MHRA, and all commercially sensitive information is handled according to strict confidentiality protocols. Where commercially sensitive data is discussed at a NICE committee, this takes place in a private session, as it always has.

At the same time, transparency remains a cornerstone of how both organisations operate. NICE will continue to hold public committee meetings, and any draft guidance published before marketing authorisation is granted will clearly state that final guidance is subject to the licence being approved.

What comes next?

The launch of these services is the start, not the finish. We are committed to evaluating the pathway continuously, focusing on where same-time publication was not achieved and how we can improve.

To find out more about the aligned pathway or to schedule your topic, contact scheduling@nice.org.uk. To explore the Integrated Scientific Advice service, visit GOV.UK for guidance and to submit a request, or get in touch with NICE Advice for an informal discussion.