Get Brochure

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.


The Pharmacovigilance Risk Assessment Committee (PRAC) is a cornerstone of the European Medicines Agency's efforts to ensure the safety of medicines across the EU. Through its comprehensive roles and functions, PRAC plays a pivotal role in the pharmacovigilance consulting system, ensuring that the benefits of medicines outweigh their risks. The work of PRAC is vital for maintaining public confidence in the EU's healthcare system and in the safety and efficacy of medicines available to its citizens. By meticulously assessing risks, managing safety signals, and coordinating with national competent authorities, PRAC ensures that the regulatory framework for medicines in the EU is robust and responsive to emerging safety information. This contributes significantly to the protection of public health and to the advancement of public trust in medicine.

How can we help you?
Call us on:+1 (302) 601-2755
Contact our experts today !
bio InternationalDia Global