Monitoring in the EU

The monitoring of the safety of medicines, also known as pharmacovigilance, is the science and activity relating to the detection, assessment, understanding and prevention of side effects and other medicine-related problems. The European Union (EU) has a rigorous system in place for planning for pharmacovigilance, for assessing the safety of a medicine once it is authorised and for taking appropriate action when required to protect public health.

The EU pharmacovigilance system

The regulatory pharmacovigilance system of the EU comprises:

  • the national medicines regulatory authorities in the Member States;
  • the European Commission as the competent authority for medicinal products authorised centrally in the EU;
  • the European Medicines Agency, with responsibilities for centrally authorised products and system coordination.

Tasks within the system

The EU system engages in the following tasks:

  • collecting data from all available sources, including case reports on individual patients, epidemiological studies and clinical trials;
  • analysing data and identifying signals of possible new or changing risks;
  • assessing risk-management plans, case reports, study reports, periodic safety update reports and benefit-risk reviews submitted by marketing-authorisation holders;
  • inspecting marketing-authorisation holders;
  • evaluating risks in terms of likelihood, seriousness and risk factors;
  • managing risks, often through further investigations and actions to restrict the use of the medicine.

Pharmacovigilance by pharmaceutical companies

The company that holds the marketing authorisation for a medicine has legal obligations to continuously collect data and conduct pharmacovigilance activities. Data has to be transmitted to the authorities within defined timelines, and any emerging concern about the benefit-risk balance has to be notified immediately. If necessary, the authorities may request further investigations. Various official procedures exist for updating product information and implementing other safety measures, with varying degrees of urgency. Companies are subject to inspections.

The European Medicines Agency plays a key role in the safety-monitoring of medicines in the EU. The Agency's main role in this area includes coordination of the European pharmacovigilance system, providing information on the safe and effective use of medicines, and managing and maintaining the EudraVigilance system. The Agency has additional specific tasks for centrally authorised products including signal detection. See more information on the Agency's work in supporting the European pharmacovigilance system.