Request for Integrated Scientific Advice

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Request for Integrated Scientific Advice: step by step

Check what you need to do to request for Integrated Scientific Advice from the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE).

You can find more detailed information on the process at Get more help to request for medicines Integrated Scientific Advice (ISA)

  1. Step 1Check which type of scientific advice you need (optional)

    The MHRA and NICE both offer standalone scientific advice as well as the Integrated Scientific Advice service.

    Check what service is right for your product or medicine.

  2. Step 2Request Integrated Scientific Advice

    You will need to provide information about your request. Information requested includes:

    • contact details for regulatory communication, secondary contact details and invoicing
    • information about your project and product
    • information about the subject matter of expertise and advice you need
    • a document containing the final questions you need advice on
    • reference details or documents from MHRA, NICE and other authorities such as EMA, JSC or FDA

    To make a new application select Request Integrated Scientific Advice or to retrieve a saved application select Return to saved application

    You can save and return to your application at a later date if you need to.

    After submitting your request you will then be contacted by the team.

    Useful links

  3. Step 3Submit your briefing book

    After submitting the request you will be provided with a date for your advice meeting. You must then submit a briefing book 4 weeks after submitting your application form.

    Submit your briefing book

    Useful links

  4. Step 4Pay for Integrated Scientific Advice

    There is a fee for Integrated Scientific Advice, paid to one organisation. It is calculated by both organisations but paid as a combined fee.

    Useful links

  5. Step 5Prepare for your meeting

    You will need to create and share a presentation that explains your project and the specific questions you’d like advice on.

    Useful links

  6. Step 6Receive the report and next steps

    After the Integrated Scientific Advice meeting you will be provided with a report based on your questions. You can request clarifications, if needed.

    Useful links