The MHRA welcomes requests for licence applicants for a joint scientific advice meeting with NICE to discuss their development plans for medicinal products. This process offers the following opportunities:
- guaranteed face-to-face meeting with both organisations together
- discussion of clinical study(s) design that will be used to satisfy regulatory and NICE requirements
- optional advisory input from Clinical Practice Research Datalink (CPRD).
Following a meeting with the applicant, the MHRA and NICE will produce separate advice documents to answer the any questions raised during the meeting. Applicants can also ask for advisory input from CPRD.
Applicants interested in getting scientific advice should provide:
- a brief synopsis of the product for which advice is sought
- the stage of development
- the nature of the issues to be discussed.
Applicants should also confirm that:
- they have not received scientific advice from the Committee for Medicinal Products for Human Use (CHMP), or submitted a marketing authorisation for the products to be discussed
- a NICE technology appraisal of the product is not scheduled to start within the timeframe of the advice project.
Once it is agreed that a meeting can take place, the applicants will need to submit a briefing book clearly stating their position on each question posed. Applicants should also state when they need the advice by. The brief synopsis should be three pages or shorter.
Please contact David Wright at the MHRA or Richard Chivers at NICE for further information.