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Monitoring safety. Averting danger.


By the time medicinal products are granted a marketing authorisation, knowledge about their safety is incomplete because the clinical trials investigating the safety profile and efficacy are usually performed with a relatively small number of subjects. Furthermore these subjects are selected with regard to special aspects and in general do not represent the average patient in medical practices. Therefore, rare or very rare adverse drug reactions, interactions or other hazards related to the use of a medicinal product cannot be observed during clinical trials. Especially the rarely occurring serious adverse reactions are very important for the overall assessment of a new medicinal product. New findings regarding the safety of a medicinal product may occur even long time after its authorisation and depend on new developments in medical science.

Therefore, the German Medicines Act (Arzneimittelgesetz, AMG) provides that information obtained during the use of a medicinal product be continuously and systematically collected and evaluated after the marketing authorisation is granted. This is done for all finished products on the market in Germany and is the most important duty of the Pharmacovigilance Division. This Division continuously informs about adverse drug reactions and interactions related to the use of medicinal products which have become known and ensures that patients, medical doctors and other interested parties are made aware of existing risks as well as of possibilities to decrease them. If, due to the risk assessment of a medicinal product, its marketing authorisation status needs to be adopted to the state of scientific knowledge, the Pharmacovigilance Division co-ordinates the measures necessary for risk prevention and informs patients, medical doctors and other interested parties accordingly.

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