New joint MHRA-NICE approval pathway and an improved Integrated Science Advice (ISA) service

MHRA and NICE are launching an aligned pathway together with an improved Integrated Scientific Advice service to accelerate patient access to medicines and provide a more efficient route for industry. This will offer a single-entry point, meeting and report, and one payment, while aligning data and scientific expectations where possible.1

Who will the joint pathway benefit?

It will benefit patients in England who are set to receive some new medicines three to six months earlier under the streamlined approval process being launched.1

When will the new joint pathway be launched?

The aligned pathway will be launched on 1 April 2026.1

What is the main driver for the joint pathway?

It will help to bring NICE’s decision-making process forward to run alongside MHRA’s, resulting in decisions on licensing and value being made at the same time.1

Which products are eligible for the joint pathway?

This information is not yet included in the guidance from the MHRA or NICE.

Is the aligned pathway mandatory or optional?

The aligned pathway is entirely optional, giving companies full control over their submission strategy.3

  • Companies can choose to request a later submission date, following the traditional sequential approach.3
  • This flexibility is particularly valuable for companies whose global development programmes or regulatory timelines do not currently align with the earlier submission requirements.3
How the aligned pathway will work3

Currently, there’s a 90-day gap between MHRA marketing authorisation grant and NICE guidance publication.

  • Under the aligned pathway, NICE’s scheduling processes is being brought forward to eliminate this delay.
  • NICE appraisal committee meetings will now be able to take place in public before marketing authorisation grant.
  • NICE can also publish both draft guidance and final draft guidance before the MHRA decision – with the caveat that recommendations are subject to marketing approval.
  • This represents a significant shift in how NICE currently coordinates its activities.
What’s can pharmaceutical companies prepare for this pathway?3

To facilitate these changes, the aligned pathway requires companies to engage with NICE early by registering their product on UK PharmaScan at least 3 years prior to expected MHRA marketing authorisation.

  • Companies will also need to commit (at global level) to adhering to the timelines.
  • To support this approach, NICE will offer priority scheduling, ensuring that these medicines can progress through its evaluation process in time to achieve simultaneous publication with regulatory decisions.
  • NICE is also offering an improved and fully integrated scientific advice service, designed to help companies adhere to the timings by gaining clarity on evidence requirements and avoiding unnecessary delays.
What will happen in those instances when an earlier submission to NICE is not possible?3

NICE recognises that not all medicines will be suitable for the aligned pathway.

  • Some complex topics may require alternate scheduling, where NICE will not progress to committee until marketing authorisation is granted.
  • This ensures that NICE maintains its rigorous evaluation standards while providing flexibility for more challenging assessments.
  • For companies that cannot meet NICE submission timelines which puts the start of their NICE evaluation before marketing authorisation, NICE will publish a deferral.3
  • This will provide complete transparency on when NICE will evaluate a medicine following grant of marketing authorisation.
Will the MHRA and NICE maintain independence and transparency?3

NICE and MHRA will continue to operate independently, maintaining their distinct evaluation standards.

  • While NICE is aligning its timelines and improving operational information sharing, each organisation will retain its own rigorous assessment criteria and decision-making processes.
  • MHRA will continue to focus on safety, quality and efficacy for regulatory approval, while NICE will maintain its established framework for evaluating clinical and cost effectiveness.
  • NICE also remains committed to maintaining its public committee meetings and transparency standards.
Guidance on applying for medicines Integrated Scientific Advice (ISA)2

The MHRA has published comprehensive guidance on the required preparation for the MHRA and NICE Integrated Scientific Advice (ISA) service. This will offer a single-entry point, meeting and report, and one payment, while aligning data and scientific expectations where possible.1

The service offers a coordinated approach from the the MHRA and NICE to regulatory and health technology assessment (HTA) advice for medicine developers.

Integrated Scientific Advice has been designed to help companies follow the aligned pathway timelines by clarifying regulations and the evidence required early in the development process. This will help companies improve their clinical development plans and reduce unforeseen delays.1

The service is designed to provide enhanced clarity and confidence in investment decisions by optimising evidence requirements early, ensuring they meet the requirements of both organisations and avoid unforeseen delays. Through greater operational alignment and secure data sharing, the integrated advice service will offer a much smoother user experience.3

Users can expect more predictable timelines and will access the service through a single enquiry form, receive one advice meeting, an integrated report and make a single payment.3

The guidance is available under the following headings:

  1. Writing good questions for Integrated Scientific Advice (ISA) – As part of requesting Integrated Scientific Advice (ISA) MHRA and NICE, you must complete a list of questions that will be developed into your briefing book. The preference is that the questions are prospective and concern the future development of a medicinal product. The questions you ask should be as precise and clear as possible.
  2. Creating an ISA briefing book – As part of requesting Integrated Scientific  you must complete a briefing book.
  3. Find out about fees for the ISA service – The company will initally be charged 70% of the Integrated Scientific Advice fee when the project agreement is signed. The outstanding balance (30%) will be charged upon completion of the project services.  
  4. Getting the most from your ISA meeting – Companies requesting Integrated Scientific Advice will have a meeting with the MHRA and NICE. This is a chance to present the project and get answers to specific questions. Meetings are planned for up to 2 hours.
  5. Understanding your ISA report – As part of the Integrated Scientific Advice (ISA) service, the MHRA and NICE have a single report structure. 
  6. All Integrated Scientific Advice (ISA) service application questions – This is a list of all the questions you will need to answer to request Integrated Scientific Advice (ISA) from the MHRA and NICE. Following the advice meeting MHRA and NICE have 6 weeks to jointly write and review the report. The report and instructions on how to access it will be sent to the advice enquirer via NICE Docs.
  7. MHRA and NICE Integrated Scientific Advice briefing book template

Source: MHRA

References

1. Press release: Patients to get new medicines up to six months sooner under new joint MHRA-NICE approval process, 17 March 2026, MHRA.

2. Guidance: Get more help to apply for medicines Integrated Scientific Advice (ISA), 20 February 2026, MHRA

3. Same time decisions on licensing and value – what pharmaceutical companies need to know, 10 October 2025, NICE