Creating an ISA briefing book
Published 20 February 2026
© Crown copyright 2026
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/get-more-help-to-apply-for-medicines-integrated-scientific-advice-isa/creating-an-isa-briefing-book
As part of requesting Integrated Scientific Advice (ISA) from Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) you must complete a briefing book.
The MHRA and NICE will determine which organisation responds to each question in the book.
Briefing book format and style
Use the briefing book template
You should submit 1 electronic copy of the briefing document in Word format, using the briefing book template. It should not exceed 50 pages (excluding references) or 10MB in size.
What to include
The briefing book should include:
-
the final proposed questions together with your position on each question in Word format
-
any appendices
-
labelling and leaflet artwork examples if the meeting is about changes to labelling and leaflets for a product or range of products
You can insert the company logo on the title page.
Content and structure
Clear and concise questions
You should ideally use the Population, Intervention, Comparison, and Outcome (PICO) framework. For each question you should:
-
explain the company’s position in detail, cross referring to other sections of the briefing book as needed
-
describe the background and context to your question - refer to current NHS practice, MHRA regulations and NICE approved guidance and methods
Evidence details
You should:
-
include details of the evidence you are generating, and why this would be suitable - for example, explain your rationale for choosing the trial population, comparators and outcomes, or overall trial design
-
explain if it’s not feasible to generate certain evidence
Supporting information
You should:
-
provide all study protocols
-
include essential annexes (such as reports or protocols) separately rather than embedding them
-
not include preclinical, pharmacodynamic, or pharmacokinetic data unless directly relevant
Referencing
You do not need to reference every statement. Provide references only if they relate to the methodology or the questions asked.
Further information and how to get in touch
Further information
Request Integrated Scientific Advice
See detailed guidance on Integrated Scientific Advice
See supplementary information on the ISA service