Europe – EMA : Guidance for Applicants seeking scientific advice and protocol assistance

This guidance document addresses a number of questions that users of the scientific advice or protocol assistance procedures may have.

It provides an overview of the procedure to obtain scientific advice or protocol assistance and gives guidance to Applicants in preparing their request. This guidance document 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 and which can be validated and evaluated quickly and efficiently..