MHRA NICE Integrated Scientific Advice Service Guidance

MHRA Guidance & Safety

Published February 20th, 2026

Detected March 17th, 2026

Summary

The MHRA and NICE have updated guidance on their Integrated Scientific Advice (ISA) service for medicine developers. The updates provide additional information on preparing for ISA meetings, including specific guidance on writing questions, creating briefing books, and understanding ISA reports and fees.

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What changed

The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have updated their guidance concerning the Integrated Scientific Advice (ISA) service. This update provides supplementary information for medicine developers seeking coordinated regulatory and health technology assessment advice. Key areas covered include advice on formulating effective questions for the ISA service, preparing necessary documentation such as briefing books, understanding the fee structure, and maximizing the benefit of ISA meetings and reports.

While this update is primarily informational and does not introduce new regulatory obligations or deadlines, developers utilizing the ISA service should review the updated guidance to ensure their applications and preparations are aligned with the latest recommendations. The updated documents aim to streamline the application process and enhance the value of the scientific advice provided by the MHRA and NICE.

What to do next

Review updated guidance on Integrated Scientific Advice (ISA) service application questions
Consult updated briefing book template and guidance on preparing ISA documentation

Source document (simplified)

Guidance

Get more help to apply for medicines Integrated Scientific Advice (ISA)

Extra information for the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) Integrated Scientific Advice (ISA) service.

From: Medicines and Healthcare products Regulatory Agency and National Institute for Health and Care Excellence Published 20 February 2026 Last updated 16 March 2026
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Documents

Writing good questions for Integrated Scientific Advice (ISA)

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Creating an ISA briefing book

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Find out about fees for the ISA service

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Getting the most from your ISA meeting

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Understanding your ISA report

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All Integrated Scientific Advice (ISA) service application questions

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MHRA and NICE Integrated Scientific Advice briefing book template

MS Word Document, 4.57 MB

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Details

This service offers a coordinated approach from the the MHRA and NICE to regulatory and health technology assessment (HTA) advice for medicine developers. See specific information on: