Whereas pharmaceuticals prepared by extraction of medicinal plants constitute an important part of evidence-based medicine also in the Western Hemisphere, medicinal mushrooms are mainly used as dietary supplements without declaration of a medical indication. Scientific investigations and case studies from Asian medicine show that fungi have very promising pharmacological potential. This article provides an overview of the principles of authorization and market access of herbal drugs in Europe, with special reference to Germany. The current status regarding mushrooms is reported, with an aim toward supporting the development of legalized pharmaceutical preparations of medicinal mushrooms in Europe.