Updated to inform organisations that they are required to submit their final briefing document(s) and questions at the point of requesting Scientific Advice, with this becoming mandatory from September 2026.
The supporting document guidance has been expanded to clarify expectations for company positions, scientific justification and alignment with relevant regulatory guidance.
Additional information has been added on areas of expertise, including pharmacovigilance, risk minimisation, and the use of real-world data and evidence, as well as the MHRA-NICE Real-World Evidence Scientific Dialogue service.
Meeting arrangements have also been clarified, including teleconference as the default format, clarification on recording the meeting, and logistics of in-person meetings unless agreed in advance by the Chair.
Updateddetailed guidemedicines and healthcare products regulatory agency