The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has adopted the final rules of procedure for public hearings to be held by the Committee. The rules of procedure depict the process and useful provisions for the groundwork, conduct and follow-up of public hearings.
For execution of these regulations, the European Medicines Agency (EMA) will arrange a domestic dry run exercise just to check the progression and trial of public hearings. The dry run is scheduled to take place at the PRAC meeting in July 2016. Public hearings could arrange as early as the fourth quarter of 2016, as soon as a significant topic is decided.
Public hearings are a new contrivance for EMA to connect European Union (EU) citizens in the regulation of medicines and to listen to their analysis, views, visions and practices. The pharmacovigilance legislation has given the PRAC the opportunity to hold public hearings as part of definite and useful reviews of medicines, mainly relevant to their therapeutic effects and available therapeutic substitutes, as well as the possibility and approval of planned and projected risk management.
According to Noël Wathion, EMA’s Deputy Executive Director, “Public hearings will improve the scientific decision-making process on the safety of medicines.”
Public hearings will be held on a case-by-case basis, where the Committee determines that assembling the outlook of the public would bring added value to its review.
Date: 15/04/2016