Drug approval is a complex process that requires a detailed assessment of data and evidence to ensure that the drug is safe and effective. The regulatory authorities review the results of the clinical trials as well as the data from the non-clinical studies to assess the risk-benefit ratio. The results of stability studies, pharmacological and toxicological studies as well as data on the manufacture and quality of the medicinal product are also taken into account. After successful evaluation and approval, the medicinal product is authorized for the specific indications on the market. A medicinal product may only be approved for the indication for which it has been tested in clinical trials. This means that a new approval procedure is required for each new indication.
For the approval of medicinal products, extensive data is required to assess the efficacy and safety of the medicinal product. Manufacturers must submit extensive clinical and non-clinical studies to assess the risk-benefit ratio of the medicinal product. The regulatory authorities carefully monitor the complex and lengthy approval process before granting marketing authorization.
The Federal Institute for Drugs and Medical Devices (BfArM) is responsible for the approval of medicinal products in Germany and works closely with the Paul Ehrlich Institute, which is responsible for vaccines and biological medicinal products. The BfArM examines the applications and carries out a comprehensive assessment to ensure the safety, efficacy and quality of the medicinal product. Authorization is granted on the basis of a risk-benefit assessment.
