NICE-MHRA scientific advice

Designed for developers of medicinal products and other similarly regulated technologies. Allows you to seek joint regulatory advice from the Medicines and Healthcare products Regulatory Agency (MHRA) and NICE Scientific Advice.

  • A 4 hour face-to-face meeting with NICE, MHRA and a panel of experts.
  • Single advice report with a joint NICE and MHRA advice summary.
  • Detailed exploration of health technology assessment and regulatory issues.

If you are an SME seeking joint advice from NICE and the MHRA, the process is slightly different. Please contact us to discuss your options.

Make an enquiry

Frequently asked questions

We were pleasantly surprised by NICE’s collaborative approach and keenness to understand the project!

Project feedback questionnaire
 

The process

If you think you've left it too late to seek scientific advice, contact us. We may still be able to help.

  • First contact

    You contact us to discuss your requirements. You answer a series of preliminary questions about your product. We contact the MHRA and agree a timeline between the 3 parties.

  • You sign and return the contract

    This must happen before the agreed submission date for the draft briefing book.

  • Send us your draft briefing book

    This is the key document that the project is centred around. A briefing book template for pharmaceutical companies is available for you to use.

  • We send you a quote

    Based on the content of your draft briefing book, we send you an initial quote for the project. You then have an opportunity to make any changes to your final briefing book before submitting the final version.

  • wk1

    Submit your final briefing book

  • We confirm the project fee

    Once we've reviewed the final briefing book, we confirm the fee. This may differ from the initial quote, if any changes were made.

  • We send you an updated contract

    We update the contract with the confirmed project fee and send you a copy for your records.

  • wk6

    We may ask some clarification questions about your product development plans

    Having identified and spoken to our panel of experts and the MHRA, we may ask you to clarify or provide further information on certain details in your briefing book.

    You'll have approximately 2 weeks to respond.

  • wk10

    We hold a face-to-face meeting with you, MHRA and a panel of experts

    Held in London, this will be a 4 hour exploratory open discussion of the issues we have identified in your briefing book. This helps us formulate our answers for the final advice report.

  • wk20

    We send our advice reports

    The final advice reports from NICE and the MHRA are combined into one overall report with a joint summary agreed by both parties.

    Please allow a further 2 weeks if your project is classified as large.

Clarification stage (optional)

  • +3 wks

    You can send us any clarification questions you have about the report

    These questions are to clarify the meaning of the advice and cannot be requests for new information.

    Further follow-up advice can be arranged for an additional fee. Please contact us to discuss any requirements.

  • +7 wks

    We respond to your clarification questions, in writing