The European Medicines Agency (EMA) have released a guidance document addressing a number of questions that users of the scientific advice or protocol assistance procedures may have.
The guidance provides an overview of the procedure related to obtaining scientific advice or protocol assistance and gives instructions to Applicants when preparing their requests. It also explains the scope and nature of scientific advice and protocol assistance. It will enable Applicants to submit requests which are in line with Scientific Advice Working Party (SAWP) requirements, allowing efficient validation and evaluation.
Additionally, the guidance describes different steps of the procedure on the preparation of a possible discussion meeting with the SAWP.
Recently, the EMA announced that from 19 October 2020 drug developers will have to use the IRIS Regulatory & Scientific Information Management Platform to request scientific advice.
To view the full guidance document on scientific advice and protocol assistance, click here.