 The review discusses the current state of knowledge about botanical medicines, specifically focusing on their safety, efficacy, quality control, marketing and regulatory aspects. Phytotherapeutic agents are standardized herbal preparations that contain active ingredients from plants. The worldwide phytotherapeutic market has grown significantly in recent years, attracting the interest of pharmaceutical companies. However, insufficient data exist for most plants to ensure their quality, efficacy and safety. Plants can be toxic and adverse effects of phytotherapeutic agents have been confirmed through clinical trials. Several regulatory models are currently available, including prescription drugs, over-the-counter substances, traditional medicines and dietary supplements. The general tendency is to perpetuate the German Commission-e experience, which combines scientific studies and traditional knowledge. Biotechnological studies and genetic improvement of medicinal plants offer great advantages by providing uniform and high-quality raw materials that are essential for the efficacy and safety of herbal drugs. This article was authored by J.B. Calixto. We are article.tv, links in the description below.