EMA Scientific Advice and Protocol Assistance

Executive Summary

Scientific advice is designed to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefit of patients. The European Medicines Agency (EMA) can give scientific advice to companies involved in developing medicines.

Scientific advice provides voluntary, non-binding and confidential discussions between pharmaceutical companies and HTA bodies, sometimes in parallel with regulatory bodies. Discussions can revolve around development strategies, clinical and/or economic aspects and other related questions companies may have.

Following scientific advice, the company produces the minutes of the face-to-face meeting, which are validated by the HTA bodies, and the HTA bodies provide written answers to questions raised by the applicant not answered during the meeting.