Safety monitoring of medicines

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The European Medicines Agency plays a key role in the safety monitoring of medicines in the European Union (EU) - this is known as pharmacovigilance. The Agency’s main role in this area is to support the coordination of the European pharmacovigilance system and to provide advice on the safe and effective use of medicines.

Before a medicine is authorised for use, evidence of its safety and efficacy is limited to the results from clinical trials. This means that at the time of a medicine’s authorisation, it will only have been tested in a relatively small number of patients for a limited length of time.

Some side effects or 'adverse reactions' may not be seen until a very large number of people have received the medicine and used it over longer time periods. This only happens once healthcare professionals begin prescribing. It is therefore vital that the safety of all medicines is monitored throughout their use in healthcare practice.

Pharmacovigilance Risk Assessment Committee

The Pharmacovigilance Risk Assessment Committee (PRAC) carries out most of the Agency's work on pharmacovigilance. The PRAC is a committee made up of experts from regulatory authorities in Member States and other specialised institutions.

The PRAC took over many of the responsibilities from the Pharmacovigilance Working Party (PhVWP). The PhVWP's last meeting was in July 2012.

EudraVigilance

The Agency is also responsible for the development, maintenance and co-ordination of EudraVigilance, a system for reporting suspected cases of adverse reactions to a medicine.

EudraVigilance is a single repository for reports of suspected adverse reactions to medicines from practice and from clinical trials. The system allows the detection of signals of suspected adverse reactions that were previously unknown and new information on known adverse reactions.

EudraVigilance data are analysed at least every month. For some medicines this is done more frequently, at least every two weeks. A list of all medicines authorised through the Agency detailing the frequency of their monitoring is available:

The Committee for Medicinal Products for Human Use (CHMP) and the PRAC evaluate signals from EudraVigilance and may recommend regulatory action as a result.

EudraVigilance is used by Member states, the Agency and industry.

For more information on how the Agency interprets information on reported cases of suspected adverse reactions to medicines, see this document:

Release of data from EudraVigilance

Data from EudraVigilance are published in the European database of suspected adverse drug reaction reports.

This website allows users to view the total number of individual suspected side effect reports submitted to EudraVigilance for each centrally authorised medicine. Users can sort these reports by age group, sex, type of suspected side effect and outcome.

Reports for common drug substances used in nationally authorised medicines will be published during 2013.

European Risk Management Strategy

The European Risk Management Strategy (ERMS) is a programme of the Heads of Medicines Agencies (HMA) network. The Agency is a member of this network.

ERMS aims to strengthen pharmacovigilance systems by putting measures in place to allow the early detection, assessment, minimisation and communication of risks of medicines in Europe throughout their lifecycle.

Improving monitoring and safety co-ordination

The Agency plays a central co-ordinating role in PROTECT, a project of the Innovative Medicines Initiative (IMI). PROTECT is aimed at strengthening the monitoring of the benefits and risks of medicines in Europe by developing innovative tools and methods that will enhance the early detection and assessment of adverse reactions.

The Agency also provides secretariat support to the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), a network that supports independent, post-authorisation studies on the safety and benefit/risk aspects of specific medicines.

The Agency works with the Food and Drug Administration (FDA) of the United States of America on signal detection activities. It also informs the World Health Organization (WHO) of any measures taken regarding centrally authorised medicines that may have a bearing on public health protection in countries outside the EU.

More information