PRAC will now take the public’s views on safety of medicines into account

Life Sciences and Health Care  Written on 22.08.2016

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), the committee responsible for assessing all aspects of the risk management of medicines for human use in the EU, has adopted rules of procedure for public hearings and may now consider the views of the public in connection with supervision of medicines.

In April 2016, PRAC adopted the final rules of procedure for public hearings to be held by PRAC. The rules include all aspects of public hearings such as the language regime of the hearings, the impact on the PRAC opinion, guidelines on how to request to attend as observer at the public hearings etc. The rules can be found here >

According to the rules, public hearings will take place on a case-by-case basis, as PRAC – in the given case –will determine if the views of the public is expected to bring any added value to PRAC’s review of the medicine in question.

With the adoption of the rules, public hearings are supposed to enrich the scientific decision-making process on the safety of medicines and are to be used as a new tool for the EMA to involve the public in the process of supervision of medicines.

Following PRAC’s adoption of the rules, an internal so-called dry run exercise organized by the EMA to test the process and procedures of the public hearings took place in July 2016. The dry run exercise was successful according to the EMA, and the first public hearings can, thus, take place as early as the last quarter of 2016.