The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System

Priya Bahri (), Georgy Genov, Peter Arlett, Viola Macolić Šarinić, Evdokia Korakianiti, Alexis Nolte, Martin Huber and Sabine M. J. M. Straus
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Priya Bahri: European Medicines Agency (EMA)
Georgy Genov: European Medicines Agency (EMA)
Peter Arlett: European Medicines Agency (EMA)
Viola Macolić Šarinić: European Medicines Agency (EMA)
Evdokia Korakianiti: European Medicines Agency (EMA)
Alexis Nolte: European Medicines Agency (EMA)
Martin Huber: Federal Institute for Drugs and Medical Devices
Sabine M. J. M. Straus: EMA Pharmacovigilance and Risk Assessment Committee

Drug Safety, 2024, vol. 47, issue 10, No 2, 956 pages

Abstract: Abstract This article reflects on the 2010 pharmacovigilance legislation of the European Union (EU). Its legislative aim of better patient and public health protection through new responsibilities for pharmaceutical companies and regulatory bodies is considered to have been achieved and is well supported by the good pharmacovigilance practices ‘EU-GVP’. For future progress, we set out a vision for high-quality pharmacovigilance in a world of ongoing medical, technological and social changes. To deliver this vision, four principles are proposed to guide actions for further progressing the EU pharmacovigilance system: synergistic interactions with healthcare systems; trustworthy evidence for regulatory decisions; adaptive process efficiency; and readiness for emergency situations (the ‘STAR principles’). Like a compass, these principles should guide actions for building capacity, technology and methods; improving regulatory processes; and expanding policies, frameworks and research agendas. Fit for the future, the EU system should achieve further improved outputs in terms of safe, effective and trusted use of medicines and positive health outcomes within patient-centred healthcare.

Date: 2024
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DOI: 10.1007/s40264-024-01451-3

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