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Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The European Medicines Agency (EMA) coordinates the European Union (EU) pharmacovigilance system and operates services and processes to support pharmacovigilance in the EU.
Before a medicine is authorised for use, evidence of its safety and efficacy is limited to the results from clinical trials, where patients are selected carefully and followed up very closely under controlled conditions. This means that at the time of a medicine's authorisation, it has been tested in a relatively small number of selected patients for a limited length of time.
After authorisation the medicine may be used in a large number of patients, for a long period of time and with other medicines. Certain side effects may emerge in such circumstances.
It is therefore essential that the safety of all medicines is monitored throughout their use in healthcare practice.
EU law therefore requires each marketing authorisation holder, national competent authority and EMA to operate a pharmacovigilance system. The overall EU pharmacovigilance system operates through cooperation between the EU Member States, EMA and the European Commission. In some Member States, regional centres are in place under the coordination of the national competent authority.
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing and monitoring the safety of human medicines. It is made up of experts in medicines safety from regulatory authorities in Member States, plus scientific experts and representatives of patients and healthcare professionals nominated by the European Commission.
EMA supports the PRAC by providing data from clinical practice available in electronic health records or prescription databases.
The Agency is responsible for developing and maintaining EudraVigilance, a system for managing and analysing information on suspected adverse reactions to medicines authorised in the European Economic Area (EEA).
EMA publishes data from EudraVigilance in the European database of suspected adverse drug reaction reports.
Users can view the total number of individual suspected side effect reports submitted to EudraVigilance for each centrally authorised medicine.
Reports for drug substances used in nationally authorised medicines are also available since October 2014.
The pharmacovigilance plan for COVID-19 vaccines sets out how EMA and the national competent authorities in the EU Member States identify and evaluate any new information that arises promptly, including any safety signals that are relevant for the benefit-risk balance of these vaccines:
For more information, see:
The Agency works closely with a number of internal partners, in particular:
- United States Food and Drug Administration (FDA): sharing information on drug safety issues and on anticipated regulatory action, public information and communication prior to decision-making and publication.
- World Health Organisation (WHO): communication of any measures taken regarding centrally authorised medicines that may have a bearing on public health protection in countries outside the EU.
The Agency supports process and scientific improvement in pharmacovigilance by participating in certain research projects, such as:
In 2017, the PRAC established a strategy for measuring the impact of pharmacovigilance activities, aiming to shift the focus of pharmacovigilance towards activities and regulatory tools that are most relevant to patients and make the biggest difference in daily healthcare:
This relies on a collaborative approach with all stakeholders and focuses on four key areas:
- measuring the effectiveness of risk-minimisation measures;
- measuring the effect of specific pharmacovigilance processes (e.g. post-authorisation safety studies);
- effective engagement with patients and healthcare professionals as key stakeholders;
- advanced methodologies to measure how pharmacovigilance activities are translated into health outcomes.
The PRAC has published a checklist with criteria to prioritise collaborative impact research for identifying and selecting safety topics discussed at the PRAC which require the generation of data to monitor the impact of regulatory interventions: