Eurordis - Rare Disease Europe

The Pharmacovigilance Risk Assessment Committee (PRAC) is the European Medicines Agency’s (EMA) committee responsible for assessing and monitoring the safety of human medicines.

The PRAC was formally established in line with the pharmacovigilance legislation which came into effect in 2012 to help strengthen the safety monitoring of medicines across Europe.

Role of the PRAC

The PRAC is responsible for assessing all aspects of risk management of human medicines, including:

• the detection, assessment, minimisation and communication of the risk of adverse reactions, while taking the therapeutic effect of the medicine into account;
• design and evaluation of post-authorisation safety studies;
• pharmacovigilance audit.

The PRAC provides recommendations on questions on pharmacovigilance and risk management systems, including the monitoring of their effectiveness, to the:

• Committee for Medicinal Products for Human Use (CHMP) for centrally authorised medicines and referral procedures;
• Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) on the use of a medicine in Member States;
• the EMA secretariat, Management Board and European Commission, as applicable.

More details about PRAC can be found on the EMA website

Albert van der Zeijden

Concepts covered:

Referrals and the role of the PRAC, The need for pharmacovigilance rules.
The legislation in place for pharmacovigilance.

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