The European Medicines Agency (EMA) 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) in the committee that is responsible for assessing and monitoring safety issues for human medicines. It is made up of experts from regulatory authorities in Member States of experts in medicines safety, and of patient and healthcare professional representatives.
The Agency is 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 new or changing safety issues.
The PRAC evaluates 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 view these reports by age group, sex, type of suspected side effect and outcome.
Reports for common drug substances used in nationally authorised medicines are available since October 2014.
European risk management strategy
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.
Measuring the impact of pharmacovigilance activities (updated)
In January 2016, the PRAC adopted a strategy for measuring the impact of pharmacovigilance activities:
The strategy builds on existing activities in the Member States and EMA, and relies on a collaborative approach with stakeholders, focusing on four areas:
- measuring the effectiveness of risk-minimisation measures on specific products;
- measuring the effect of specific pharmacovigilance processes (e.g. spontaneous reporting of suspected adverse reactions, signal management);
- investigate how to ensure engagement of stakeholders who have a key role in the successful implementation of such activities (e.g. patients, healthcare professionals);
- further improve methodologies to determine how pharmacovigilance activities are translated into health outcomes.
Measuring the impact of pharmacovigilance activities allows regulators to determine which activities are most successful, helps to improve pharmacovigilance practices where necessary and to promote best practice.
Improving monitoring and safety coordination
The Agency supports process and scientific improvement in pharmacovigilance through supporting certain research projects. This includes engagement with the WEB-RADR: Recognising Adverse Drug Reactions project on mobile reporting and social media, and ADVANCE on monitoring the benefit-risk balance of vaccines. More information is available under Support to research.
Th Organization (WHO) of any measures taken regarding centrally authorised medicines that may have a bearing on public health protection in countries outside the EU.
- 2010 pharmacovigilance legislation
- Medicines under additional monitoring
- Medication errors
- Combined hormonal contraceptives
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- 2015 annual report on EudraVigilance for the European Parliament, the Council and the Commission (21/03/2016)
- 2014 annual report on EudraVigilance for the European Parliament, the Council and the Commission (04/05/2015)
- 2013 annual report on EudraVigilance for the European Parliament, the Council and the Commission (28/04/2014)
- First annual report on EudraVigilance for the European Parliament, the Council and the Commission (26/07/2013)
- 2011 EudraVigilance Human annual report (19/06/2013)
- 2011 EudraVigilance Human annual report - Explanatory note (19/06/2013)
- Benefit/risk communication by the European Medicines Agency: a study of influential stakeholders’ expectations and attitudes (31/05/2011)