What is the Pharmacovigilance Risk Assessment Committee (PRAC)?

The PRAC was established as part of the pharmacovigilance legislation that came into effect in the EU in July 2012. It is tasked with the assessment of safety issues for human medicines, ensuring that all medicines available on the EU market are safe and effective for patients. PRAC's decisions are crucial for the protection of public health and for maintaining trust in the EU healthcare system.

What is the Importance of PRAC?

The importance of PRAC cannot be overstated. It provides a structured and scientific approach to the monitoring of drug safety, ensuring that any risks associated with medicines are identified, assessed, and managed effectively. PRAC's work supports the EMA's mission to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public health. This includes the evaluation of risk management plans (RMPs), the monitoring of data from various pharmacovigilance activities, and the coordination of EU-wide safety studies.

What is the role of the Pharmacovigilance Risk Assessment Committee

The roles of PRAC are diverse and cover various aspects of medicine safety. Key roles include:

• Assessment of Risk Management Plans (RMPs): PRAC evaluates RMPs to ensure that the measures proposed by pharmaceutical companies are adequate to identify, characterize, and minimize risks.
• Signal Detection and Management: PRAC monitors data from various sources for new or changed risks and decides on the appropriate regulatory action.
• Recommendations on Safety Issues: It provides recommendations on the safety of medicines, including changes to product information, restrictions, or withdrawal of products from the market.
• Coordination of EU-wide Safety Studies: PRAC may request or review results of post-authorization safety studies (PASS) to assess specific safety concerns.

What are the Functions of Pharmacovigilance Risk Assessment Committee

The functions of PRAC are designed to ensure the comprehensive assessment and management of the risks associated with medicinal products. These functions include:

• Evaluating signals of potential adverse reactions from various sources, including spontaneous reports, literature, and clinical studies.
• Reviewing periodic safety update reports (PSURs) to assess a medicine's risk-benefit balance.
• Assessing the need for risk minimization measures, such as amendments to the prescribing information or the implementation of educational programs for healthcare professionals and patients.
• Coordinating crisis management for medicines with identified safety issues, ensuring rapid and effective EU-wide responses.