MHRA NICE Integrated Scientific Advice Service Guidance
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.
About this source
The Medicines and Healthcare products Regulatory Agency is the UK's medicines and medical devices regulator. MHRA publications include drug safety alerts, device field safety notices, Class 1-4 defect recalls, guidance updates, and the monthly medicines shortage list. Around 55 publications a month. Device field safety notices in particular are useful because MHRA often publishes them hours before other European regulators (ANSM, BfArM) surface the same recall. Watch this if you manufacture or distribute medicines or medical devices in the UK and EU, run a hospital pharmacy, advise on MHRA licensing, or follow post-market surveillance signals across European markets.
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
Archived snapshot
Mar 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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)
HTML
Creating an ISA briefing book
HTML
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
HTML
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:
- good questions for the ISA service
- documents you need to prepare
- fees
- presenting at an ISA meeting
- ISA service reports
Updates to this page
Published 20 February 2026 Last updated 16 March 2026 show all updates
1.
16 March 2026
Changes made to update the document Scientific Advice (ISA) service application questions
2.
20 February 2026
First published.
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