Monitoring medicine safety in the EU

Monitoring the safety of medicines throughout their life cycle (pharmacovigilance) is the responsibility of the European Medicines Agency (EMA) on behalf of Member States. The European Commission has published a report, accompanied by a detailed Staff Working document, describing the activities of the collaborative EU system for monitoring and controlling the safety of human medicines.

The aim of EU rules on pharmacovigilance is to monitor the safety of medicines so that regulators can take action to reduce the risks and increase the benefits of medicines for human use. The role of individual EU countries is to monitor medicine safety data, assess signals of possible emerging side effects, and analyse the data when a safety issue is identified at European level. EMA has a central role in the EU system of pharmacovigilance as it coordinates the activities of an EU regulatory network of over 30 national competent authorities, and provides technical, regulatory and scientific support.

The report concludes that the European pharmacovigilance network is an example of successful cooperation at EU level which directly benefits patients. The networked system engages stakeholders (including healthcare professionals and patients) who can report suspected side effects directly. It operates with a high degree of transparency and ensures that EU medicines remain safe and effective and that accurate information on the safety of medicines reaches the public in a timely fashion.

Download the staff working document and report on pharmacovigilance from the ec.europa.eu website