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Public Health (08-08-2016)

Patient safety: Commission publishes report on activities to monitor medicine safety in EU

Today, the Commission publishes a report on activities by Member States and the European Medicines Agency (EMA), to monitor the safety of medicines throughout their life cycle (a process called ‘pharmacovigilance’), as foreseen by the 2010 amendment of the EU legislation from 2001 and 2004. The report, accompanied by a detailed Staff Working document, describes the activities of the collaborative EU system for monitoring and controlling the safety of human medicines since the new legislation came into effect in 2012 until July 2015.

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 – 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.

Work is underway on improving the system’s infrastructure, and on simplifying and streamlining existing processes where possible, to minimise the administrative burden for all stakeholders. Ongoing research in regulatory science will also support future improvements.

Links to Report and Staff Working Document

For more information on pharmacovigilance in the EU: