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pharmacovigilance

Pharmacovigilance is the ongoing monitoring of the safety of medicinal products after authorisation. It includes the collection, assessment, and reporting of adverse drug reactions, and is coordinated at EU level by the European Medicines Agency (EMA).

griechisch phármakon = Arznei, lateinisch vigilantia = Wachsamkeit

Arzneimittelüberwachung

pharmacovigilance

Clinical trials before authorisation typically involve a few thousand participants. Rare adverse reactions only emerge once a medicine is used by hundreds of thousands of people — and that is precisely why pharmacovigilance exists.

In Germany the responsible bodies are the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute; at European level, the European Medicines Agency (EMA). Reports can be submitted by healthcare professionals and by patients.

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