Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works

Abstract

This article provides an overview of the European Union pharmacovigilance system resulting from the rationalisation and strengthening delivered through the implementation of the revised pharmacovigilance legislation. It outlines the system aims, underlying principles, components and drivers for future change. At its core, the Pharmacovigilance Risk Assessment Committee is responsible for assessing all aspects of the risk management of medicinal products, thus ensuring that medicines approved for the European Union market are optimally used by maximising their benefits and minimising risks. The main objectives of the system are to promote and protect public health by supporting the availability of medicines including those that fulfil previously unmet medical needs, and reducing the burden of adverse drug reactions. These are achieved through a proactive, risk proportionate and patient-centred approach, with high levels of transparency and engagement of civil society. In the European Union, pharmacovigilance is now fully integrated into the life cycle of medicinal products, with the planning of pharmacovigilance activities commencing before a medicine is placed on the market, and companies encouraged to start planning very early in development for high-innovation products. After authorisation, information on the safety of medicines continues to be obtained through a variety of sources, including spontaneous reports of adverse drug reactions or monitoring real-world data. Finally, the measurement of the impact of pharmacovigilance activities, auditing and inspections, as well as capacity building ensure that the system undergoes continuous improvement and can always rely on the best methodologies to safeguard public health.

Big Data – How to Realize the Promise

“…It was recognized many years ago, and when required for regulatory purposes has driven global harmonization, a key component of the mission of the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use. For instance, the data model and data elements of the Individual Case Study Report, which is used for reporting of ADRs, provides clear specification of reporting requirements for ADRs . As a result, platforms, such as EudraVigilance, contain extremely well‐structured information, although the completeness and accuracy of the information within Individual Case Study Report forms is still dependent on the reporter and, hence, variable.…”

Improving the Safety of Medicines in the European Union: From Signals to Action

“…A new era of patient protection and transparency in EU medicines safety has been delivered. The implementation of the EU pharmacovigilance legislation in 2012 was the most significant change in the regulation of human medicines in the EU since 1995 . Over its first 6 years of operation, the strengthened pharmacovigilance process has resulted in over 26,000 potential signals reviewed and 453 confirmed signals assessed by the PRAC.…”

“…Established in 2012 by the EU Pharmacovigilance Legislation, the Pharmacovigilance Risk Assessment Committee (PRAC) plays a pivotal role in the safety monitoring and evaluation of medicinal products for human use and is at the core of the EU signal management process …”

The ENCePP Code of Conduct: A best practise for scientific independence and transparency in noninterventional postauthorisation studies

“…Since its beginning, the ENCePP network has served as support for the European regulatory environment in the field of epidemiology . The ENCePP network has also helped to facilitate the introduction of amended regulatory concepts and amended frameworks specifically in the field of epidemiology for the conduct of postauthorisation safety studies (PASS), and especially following also regulatory requirements coming into force with the EU pharmacovigilance legislation in 2012 . Evolution of the ENCePP network continues to support the work of EU regulatory agencies mirroring also the increased demand for generation of post‐approval data .…”

“…The generation of epidemiological evidence is sometimes relevant to support the early approval of medicines. This highlights the need for reinforcement of those concepts, to enhance trust in postapproval epidemiological research …”