Guidance

Writing good questions for Integrated Scientific Advice (ISA)

Published 20 February 2026

As part of requesting Integrated Scientific Advice (ISA) from the of the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) you must complete a list of questions that will be developed into your briefing book.

We prefer 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. Some questions will be more appropriate for integrated advice and some for the specific expertise of the MHRA or NICE.

Good questions for ISA

Product and indication(s)

Questions on:

• the name of the drug or therapy (if available) 

• the target condition(s) or indication(s) 

Reasons for seeking advice

A brief explanation why advice is being sought, with questions around:

• regulatory clarity

• development strategy

• evidence requirements

Timing

When advice is needed by, for example for:

• upcoming study starts

• regulatory submission timelines

Good questions with a bias to NICE expertise 

Reference to any specific areas of interest

Include questions around:

• safety 
• efficacy 
• clinical effectiveness 
• cost-effectiveness 

Good questions with a bias to MHRA expertise 

Questions that address specific scientific issues

Include questions around:

• quality aspects such as the chemical, pharmaceutical and biological testing necessary to demonstrate the quality of a medicinal product

• non-clinical aspect such as the toxicological and pharmacological testing necessary to demonstrate the safety of a medicinal product

• clinical aspects such as endpoints, trial duration, target population or choice of comparator

• pharmacovigilance plans and post-authorisation safety study protocols 

• an application for a variation or renewal

• advice before publishing advertising for a medicinal product. 

• changes to labelling of packaging leaflets for medicinal products or a product range. 

Development

Include questions around:

• the current stage of development (e.g. preclinical, Phase I/II/III). 

• whether you already have a draft protocol or study design

Uncertainties or open questions

Include questions around:

• any areas where the client is unsure such as whether integrated advice is appropriate

• any specific challenges in designing the current clinical development programme plans

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

Contact details

Email scientific_advice@mhra.gov.uk