Table of contents
- Pharmacovigilance in the product lifecycle
- EMA pharmacovigilance system
- Pharmacovigilance Risk Assessment Committee
- Monitoring suspected adverse reactions
- Pharmacovigilance plan for COVID-19 vaccines
- Measuring the impact of pharmacovigilance activities (updated)
- International collaboration
- Supporting research
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 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.
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).
EudraVigilance is a single repository for reports of suspected adverse reactions seen in healthcare practice and clinical trials. It is used by Member states, the Agency and industry.
The PRAC evaluates safety signals from EudraVigilance and may recommend regulatory action as a result. For more information, see Signal management.
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:
In 2017, PRAC established a strategy for measuring the impact of pharmacovigilance activities, and published a second revision in April 2022:
The strategy aims to shift the focus of pharmacovigilance towards the activities and regulatory tools that are most relevant to patients and make the greatest difference in daily healthcare.
The latest revision highlights the achievements attained since the strategy's launch, in its four key activity areas:
- effectiveness evaluation of risk-minimisation measures;
- effectiveness of pharmacovigilance processes;
- enablers of effective pharmacovigilance and stakeholder engagement;
- analytical methods for impact research.
The revised strategy also includes:
• new information on how to prioritise and carry out impact research;
• a review of industry-sponsored post-authorisation safety studies evaluating the effectiveness of risk-minimisation measures.
Update: EMA has contracted several institutions to conduct research projects collecting and analysing real-world data from clinical practice. This helps monitor the safety and effectiveness of medicines.
For an overview of impact research projects, see:
The strategy follows a 2016 stakeholder workshop on measuring the impact of pharmacovigilance activities. For more information, see:
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:
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.