On 28th January 2014, the MHRA reminded companies that it welcomes requests from licence applicants for a joint scientific advice meeting with NICE to discuss their development plans for medicinal products.
This process offers the opportunity to have a 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 and optional advisory input from Clinical Practice Research Datalink (CPRD).
Following such a meeting, the MHRA and NICE will produce separate advice documents to answer any questions raised during the meeting.
Regulis regularly assists clients with scientific advice meetings with regulatory authorities around the world; how to prepare for them, get the best from them and with the meeting itself. If you would like more information on this aspect of our services, please contact us via our Contact page.