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.
United Kingdom's (UK) withdrawal from the EU
EMA has published important information to help users of the centralised procedure prepare for the expected consequences of 'Brexit', including their obligations related to establishment within the European Economic Area (EEA). For more information, see UK's withdrawal from the EU.
Pharmacovigilance in the product lifecycle
EMA pharmacovigilance system
EMA coordinates pharmacovigilance in the EU and operates services and processes in line with EU legislation. The EMA pharmacovigilance system manual describes how EMA performs, monitors and reports on its pharmacovigilance duties for human medicines:
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.
Monitoring suspected adverse reactions
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 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:
- WEB-RADR Recognising Adverse Drug Reactions: a project on mobile safety reporting and identifying drug safety issues using social media;
- ADVANCE: a project to improve the monitoring of the benefit-risk balance of vaccines.
Measuring the impact of pharmacovigilance activities
In November 2017, the PRAC revised its strategy to measure the impact of pharmacovigilance activities. The strategy aims to improve pharmacovigilance practices and determine which activities are most successful.
This revision builds on the achievements of the initial conceptual approach of the strategy and focuses on measuring patient-relevant health outcomes of major regulatory interventions:
The strategy 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: