1. Introduction

The European regulatory system for medicines monitors the safety of all medicines that are available on the European market throughout their life cycle. EMA has a committee dedicated to the safety of medicines for human use—the Pharmacovigilance Risk Assessment Committee, or PRAC. If there is a safety issue with a medicine that is authorised in more than one Member State, the same regulatory action is taken across the EU and patients and healthcare professionals in all Member States are provided with the same guidance. All suspected adverse reactions that are reported by patients and healthcare professionals or become known by other sources (e.g. from clinical trials) must be entered through NCAs or MAHs into EudraVigilance, the EU web-based information system operated by EMA for managing and analysing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). This electronic reporting is obligatory for marketing authorisation holders and sponsors of clinical trials. These data are continuously monitored by EMA, the Member States regulatory authorities (NCAs) and marketing authorization holders (MAHs) in order to identify any possible new safety information (safety signal) (obligatory monitoring according to Commission Implementing Regulation (EU) No 520/2012 (article 18)). EMA provides online public access to reports of suspected adverse reactions for authorised medicines in EudraVigilance, the European database of suspected drug-reaction reports. The PRAC has a broad remit covering all aspects of pharmacovigilance. In addition to its role in risk assessment, the committee provides advice and recommendations to the European medicines regulatory network on risk management planning and benefit-risk assessment for medicines after marketing. In addition, the EU’s pharmacovigilance legislation enables the PRAC to hold public hearings during safety reviews of medicines if deemed useful. Public hearings are intended to support the committee’s decision-making by providing perspectives, knowledge and insights into the way medicines are used in clinical practice. A comprehensive overview of the pharmacovigilance legislation, which came into effect in 2012, and which introduced a range of tasks and streamlined existing responsibilities for regulators and the pharmaceutical industry in the European Union (EU) can be found here: https://www.ema.europa.eu/en/human-regulatory/overview/pharmacovigilance/legal-framework/implementation-pharmacovigilance-legislation .