Pharmacovigilance – Drug Safety After Authorization
Pharmacovigilance refers to all activities for the detection, assessment, understanding, and prevention of adverse effects and other drug-related problems after market authorization. It is legally mandated and forms the safety net between authorized medicines and the protection of public health.
The legal basis for pharmacovigilance in the EU is formed by EU Regulation 726/2004 and Directive 2001/83/EG, supplemented by the Pharmacovigilance Regulation (EU) 1235/2010. In Germany, the requirements are anchored in the AMG. All holders of a marketing authorization (Marketing Authorization Holders, MAH) are obliged to operate a pharmacovigilance system and to appoint a responsible person for pharmacovigilance (Qualified Person for Pharmacovigilance, QPPV).
Core responsibilities of pharmacovigilance include: the collection of spontaneous reports of suspected adverse drug reactions (ADR) from practice, the submission of periodic safety reports (Periodic Safety Update Reports, PSUR) to the authorities, the conduct of Post-Authorization Safety Studies (PASS) for known or suspected safety risks, and the immediate reporting of serious and unexpected adverse effects (Expedited Reporting) within 15 days.
The European reporting system operates through the EudraVigilance database of the EMA, to which all national authorities and marketing authorization holders have access. Signal detections – that is, the identification of new, potentially dangerous patterns – are regularly assessed by the PRAC (Pharmacovigilance Risk Assessment Committee) of the EMA. Results can lead to changes in product information, Dear Healthcare Professional letters, restrictions on indication, or in extreme cases to market withdrawal.
For physicians and pharmacists, the reporting of suspected adverse effects to the BfArM is a professional obligation and contributes significantly to drug safety. Patients can also report adverse effects directly. The pharmacovigilance system is a continuum: while clinical trials can hardly detect rare adverse effects (< 1:1000), pharmacovigilance in routine practice also uncovers very rare events that only occur in millions of applications.
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