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. 2017 Oct;40(10):855-869.
doi: 10.1007/s40264-017-0572-8.

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

Aniello Santoro  1 , Georgy Genov  2 , Almath Spooner  3   4 , June Raine  4   5 , Peter Arlett  2
Affiliations

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

Aniello Santoro et al. Drug Saf. 2017 Oct.

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.

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Conflict of interest statement

Funding

No sources of funding were used to assist in the preparation of this review.

Conflict of interest

Aniello Santoro, Georgy Genov and Peter Arlett are employees of the European Medicines Agency. Almath Spooner and June M. Raine are members of the Pharmacovigilance Risk Assessment Committee, as well as employees of the Health Products Regulatory Authority and the Medicines and Healthcare Products Regulatory Agency, respectively.

Disclaimer

The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the agencies or organizations with which the authors are affiliated.

Figures

Fig. 1
Fig. 1
European Union (EU) pharmacovigilance system: roles and responsibilities through the product life cycle. ADRs adverse drug reactions, CAPs centrally authorised products, CHMP Committee for Medicinal Products for Human Use, EC European Commission, EMA European Medicines Agency, EU European Union, NAPs national authorised products, NCAs national competent authorities, PRAC Pharmacovigilance Risk Assessment Committee, PSUR periodic safety update report, RMP risk management plan
Fig. 2
Fig. 2
Promotion and protection of public health by the European Union pharmacovigilance system
Fig. 3
Fig. 3
Core characteristics of the European Union (EU) pharmacovigilance system
Fig. 4
Fig. 4
Continuum of the European Union pharmacovigilance system from pre- to post-marketing. ADR adverse drug reaction
Fig. 5
Fig. 5
Types of Pharmacovigilance Risk Assessment Committee recommendations for signals. DHPC direct healthcare professional communication, PASS post-authorisation safety study, PI product information, PSUR periodic update safety report, RMP risk management plan, USR urgent safety restriction
Fig. 6
Fig. 6
Some of the European Union pharmacovigilance information published on the European Medicines Agency (EMA) website. CAPs centrally authorised products, EPAR European Public Assessment Report, EV EudraVigilance, NAPs nationally authorised products, PRAC Pharmacovigilance Risk Assessment Committee
Fig. 7
Fig. 7
Areas of the Pharmacovigilance Risk Assessment Committee (PRAC) strategy to measure the impact of pharmacovigilance activities. ADR adverse drug reaction, PV pharmacovigilance, SM signal management
See this image and copyright information in PMC

References

    1. World Health Organization. Pharmacovigilance. http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmv... (2017). Accessed 3 Jul 2017.
    1. European Commission. MEMO/08/782, Brussels, 10 December November 2008. Strengthening pharmacovigilance to reduce adverse effects of medicines. http://europa.eu/rapid/press-release_MEMO-08-782_en.htm?locale=en (2017). Accessed 3 Jul 2017.
    1. European Commission. Pharmacovigilance. http://ec.europa.eu/health/human-use/pharmacovigilance/index_en.htm (2017). Accessed 3 Jul 2017.
    1. European Medicines Agency. Pharmacovigilance Risk Assessment Committee (PRAC). http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/gener... (2017). Accessed 3 Jul 2017.
    1. European Medicines Agency. Good pharmacovigilance practices. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_li... (2017). Accessed 3 Jul 2017.

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