Consultation: rules of procedure for public hearings in the EMA

29 August 2014

The European Medicines Agency (EMA) has launched a public consultation on draft rules of procedures for public hearings held by its Pharmacovigilance Risk Assessment Committee (PRAC).

See the Draft rules of procedures on the organisation and conduct of public hearings

All interested parties are invited to send their comments to the EMA by 15 October 2014. Comments should be sent directly to the EMA on its website at European Medicines Agency launches public consultation on rules of procedures for public hearings

The PRAC has the possibility to hold public hearings as part of safety reviews of medicines for human use. PRAC will hold public hearings on a case-by-case basis, depending on the urgency of the matter under review and the scope and seriousness of the safety concerns.

The purpose of the public hearings is to give all interested parties an opportunity to express their views and contribute information to the safety reviews.

The EMA expects that the public hearings will focus on the public's understanding of the risks associated with the medicine, and whether they are acceptable in relation to the therapeutic effects, therapeutic alternatives available as well as risk management and minimisation activities.

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