The Benefit-Risk Evaluation of Drugs by Health Authorities in the Federal Republic of Germany

According to the Medicines Act of 1976 a specific drug has to fulfill three requirements in order to be approved: 1. Pharmaceutical quality 2. Medical efficacy 3. Medical safety. There are scientific standards for all three requirements which make it possible to check whether or not these expectations are met. This may not be easy in every case — every decision which involves approval presents difficulties — but finally it is based on scientific criteria because these standards are applied.