Definition

The EMA committee responsible for assessing and monitoring safety issues for human medicines, including signal assessment and risk management recommendations.

Example

PRAC reviews signals detected in EudraVigilance, assesses PSUR findings, and makes recommendations that may lead to label changes, restrictions, or withdrawals.

Regulatory source

EU Regulation 726/2004

Common mistakes

Not adequately preparing for or responding to PRAC requests for information or assessment reports.

Inspector question

How do you prepare for PRAC signal assessments? Describe your interaction with PRAC.

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