Post-marketing authorization period

Pharmacovigilance in the post-marketing authorization period is tightly regulated. As in North America and Japan, Europe has adopted the ICH guidelines with a few, relatively minor additions. The MA holder must have systems and qualified personnel in place to fulfill all his obligations for the monitoring of the safety of its medicinal products. 

Legally, both the authorities and manufacturers are responsible for the safety of medicinal products. In the European Union (EU), both parties are obliged to operate pharmacovigilance systems, to exchange data and, where necessary, to take appropriate action to protect patients. The responsibilities of the authorities cover all medicinal products - and there are many thousands of them. Therefore, in practice, they have to focus particularly on issues which are the most important for public health. Since the early post-marketing phase is invariably a period of considerable uncertainty about safety and when important new hazards are most likely to be identified, much of their attention is concentrated on newer drugs. 

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