PRAC | Pharmacovigilance Risk Assessment Committee

Pharmacovigilance Risk Assessment Committee

The Pharmacovigilance Risk Assessment Committee (PRAC) is a scientific committee within the EMA. It assesses the risks of medicines, including safety signals and periodic pharmacovigilance reports.

PRAC issues recommendations that may result in marketing authorisation changes, usage restrictions, or product withdrawals.

It plays a central role in safeguarding public health across the EU.