Home » Federal Health Minister Hermann Gröhe on the serious incidents during drug tests in France and information on the approval process for drugs.

Federal Health Minister Hermann Gröhe on the serious incidents during drug tests in France and information on the approval process for drugs.

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Before a drug can be launched in Germany, it has to go through and pass a strict, multi-stage approval process. The Federal Institute for Drugs and Medical Devices (BfArM) plays an important role in this. On its website, the BfArM provides detailed information on how the approval process ensures the safety of the participants (“How a medicinal product is made”). The pharmaceutical company first sends the authority the results of a pre-clinical study, in which it is clarified whether a substance is toxic, carcinogenic or gene-modifying. A test plan is also part of the submitted documents. This shows, for example, which groups of people are eligible for testing in clinical trials and under what circumstances the tests must be stopped.

All subjects are informed about the course of the study and possible risksb. You must agree to participate and can withdraw your consent at any time. The prerequisite for this is that they are legally competent and can grasp the significance of the study. Mentally ill people or minors are therefore excluded or only able to participate to a limited extent.

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