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

Last updated: 1 April 2026

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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

How will the MHRA-NICE aligned pathway benefit patients in England?

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 MHRA-NICE aligned pathway be launched?

The aligned pathway will be launched on 1 April 2026.¹

What is the main driver for the MHRA-NICE aligned ?

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

How can pharmaceutical companies benefit from using the MHRA-NICE aligned pathway?⁵

• Earlier NHS market access – NICE TA guidance will be published at the same time as MHRA marketing authorisation.
• Predictable timelines – priority scheduling from NICE and coordinated milestones to support forward-planning.
• Commercial benefits realised sooner due to earlier entry into the NHS and longer exclusivity before Voluntary Scheme for Branded Medicines Pricing Access and Growth (VPAG) rebates apply.
• NHS and global markets will be notified earlier. While the aligned pathway is one part of a broader ecosystem, the ambition is that over time, it will contribute to  speeding up NHS adoption of new medicines.

Which therapeutic areas or topics is the MHRA-NICE aligned pathway suitable for?⁵

All therapeutic areas are eligible for the aligned pathway and there is no cap on the number of companies who can use it.

Topics coming through the following pathways will be prioritised for scheduling to the MHRA-NICE aligned pathway: 

• Innovative Licensing and Access Pathway (ILAP), 
• National licensing route, 
• ACCESS consortium or 
• Project Orbis 

While integrated scientific advice is not a requirement of the aligned pathway, MHRA and NICE strongly recommend it in, at minimum, the design of your pivotal clinical trials. Early scientific advice can help you design your clinical development programme to meet both regulatory and health technology appraisal requirements, helping you to adhere to aligned pathway timelines. 

What advice is available for the MHRA-NICE aligned pathway?

The Integrated Scientific Advice service provides pharmaceutical companies with coordinated scientific advice on evidence requirements for market authorisation and health technology assessment, through a single, streamlined process. The service is most suitable for products in clinical development and aiming to follow MHRA and NICE aligned pathway timelines. 

You can ask for advice on:

• the design of pivotal studies (including those already in progress, although the MHRA recommend requesting as early as possible),
• generation of real-world evidence and
• strategic planning for regulatory and HTA requirements.

The Integrated Scientific Advice service does not provide joint scientific advice for medical devices. However, NICE offers separate services for medical technology developers and there are separate services for medicine developers wanting only regulatory advice from the MHRA or only HTA advice from NICE.

Is there guidance available on how to get Integrated Scientific Advice from the MHRA and NICE?

Yes there is, in the Guidance: Medicines: Get integrated scientific advice from the MHRA and NICE.

Is it possible to get more help to apply for medicines Integrated Scientific Advice?

Yes it is, in the Guidance: Get more help to apply for medicines Integrated Scientific Advice (ISA). This is extra information for the MHRA and NICE Integrated Scientific Advice service.

Is integrated scientific advice mandatory a mandatory requirement for the MHRA-NICE aligned pathway?⁵

While integrated scientific advice is not a requirement of the aligned pathway, MHRA and NICE strongly recommend at a minimum, for the design of your pivotal clinical trials.

Early scientific advice can help you design your clinical development programme to meet both regulatory and health technology appraisal requirements, helping you to adhere to aligned pathway timelines. 

Is the MHRA-NICE 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

Both, the MHRA and NICE continue to operate independently and maintain their own distinct evaluation standards.

How the MHRA-NICE 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 the MHRA-NICE aligned 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.

What is the sequence of steps that should be followed for the MHRA-NICE aligned pathway?⁵

Step 1: Register on UK PharmaScan

• Register your medicine on UK PharmaScan, the national horizon scanning database, at least 3 years before your expected MHRA marketing authorisation.
• This is an essential requirement for joining the MHRA-NICE aligned pathway.

Step 2: Confirm your commitment

• At the NICE topic selection stage, confirm to NICE that you can submit to their optimal timelines.
• The NICE team will then share coordinated timelines linked to your expected marketing authorisation. There is no separate application process.

Step 3: Submit to NICE and MHRA

• Submit your dossiers to the MHRA and NICE. Each organisation will assess the evidence and reach its own decisions independently.
• For optimal timelines, submit to NICE around 7 months before your expected MHRA marketing authorisation.
• Depending on the MHRA route, this may mean submitting to NICE before the MHRA.

Step 4: Receive aligned decisions

• For products on track with the pathway, NICE will schedule its appraisal committee meetings, draft guidance and final draft guidance to take place before your MHRA marketing authorisation is granted.
• Any draft guidance published before marketing authorisation will make clear that final recommendations are subject to the licence being granted.
• NICE will then publish its technology appraisal to coincide with your MHRA marketing authorisation.

Further Reading

MHRA-NICE pathway opens for business – everything you need to know to get started, 1 April 20266, nice.org.uk

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

4. Guidance: Medicines: Get integrated scientific advice from the MHRA and NICE, 24 March 2026, MHRA

5. Guidance: Get medicines to NHS patients earlier via the MHRA-NICE aligned pathway, 1 April 2026, MHRA