Phytotherapy refers to the treatment and prevention of diseases through the use of plants, plant parts, or their preparations (extracts). The medicines produced from these are referred to as phytopharmaceuticals or herbal medicinal products. In contrast to isolated pure substances, herbal extracts are often complex mixtures of many compounds, where the entire mixture is considered the active ingredient.
The regulatory requirements for the authorisation of herbal medicinal products in Europe are specific. There are various authorisation pathways: the ‘Full Application’ with proprietary clinical data (as for chemically-synthesised drugs), authorisation as a ‘traditional herbal medicinal product’ based on long-standing use experience, or the recognition of a ‘well-established use’ based on published scientific literature. Mediconomics possesses particular expertise in conducting clinical studies with phytopharmaceuticals, which require specific knowledge in the characterisation of the investigational product and in study design.