Advice alongside the regulators
Advice alongside the European Medicines Agency (EMA)
NICE Scientific Advice alongside the Medicines and Healthcare Products Regulatory Agency (MHRA)
NICE Scientific Advice welcomes requests for a joint scientific advice meeting with the MHRA to discuss their development plans for medicinal products. Following a meeting with the Company, the MHRA and NICE will produce separate advice documents to answer the respective questions raised by the Company.
In addition, as part of this parallel process, as well as standard SA process at NICE, Companies now have an option to request an advisory input from CPRD (Clinical Practice Research Datalink) to gain knowledge of what real world data might be available either observationally or interventionally.
Companies interested in taking up this option are asked to provide:
- brief synopsis of the product for which advice is sought
- the stage of its development
- the nature of the issues to be discussed
and confirm that:
- they have not received scientific advice from the Committee for Medicinal Products for Human Use (CHMP), nor submitted a marketing authorisation application on the topics they wish to receive advice on;
- a NICE technology appraisal of their product is not scheduled to start within the timeframe of the advice project.
Applicants should indicate the deadline by which they require the advice. This brief synopsis should not exceed three pages.
This page was last updated: 22 November 2013