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Pharmacovigilance Risk Assessment Committee (PRAC)

EMA's committee responsible for assessing and monitoring the safety of human medicines, including signals, risk management and post-authorisation safety issues.

Resource family Regulatory Authorities
Resource type Ema Scientific Committee
Maintained by European Medicines Agency
Jurisdiction European Union
Status Official EMA committee resource
Access Public
Official link verified 2026-09-04
Official source Visit official resource ↗

PRAC is EMA's pharmacovigilance committee for human medicines. Its work includes safety-signal assessment, risk-management issues, post-authorisation safety studies and other pharmacovigilance matters.

Useful material

The official PRAC pages provide meeting agendas, minutes, highlights, work plans and links to committee procedures.