Anthroposophic Medicinal Products: A literature review for scientific and regulatory assessment

A new study presents a comprehensive review of scientific information on anthroposophic medicinal products, with the aim of providing sufficient information on these products for the scientific community and the regulatory authorities.

Anthroposophic medicinal products form a distinct group of medicinal products. Some overlap with herbal and homeopathic medicinal products regarding ingredients and manufacturing procedures, while others are manufactured using procedures rarely used elsewhere. These specific features mean that their scientific and regulatory assessment can be challenging.

Treatment with anthroposophic medicinal products is part of a larger therapy system of Anthroposophic Medicine, which guides its use in clinical practice.

This new article provides an overview of anthroposophic medicinal products within the system of Anthroposophic Medicine, presenting various aspects including definition, pharmaceutical properties, an example of development of anthroposophic medicinal products, their use in clinical practice, similarities with and differences to conventional medicinal products, societal aspects, and a scientific and regulatory assessment.

The study concludes that anthroposophic medicinal products are part of the integrative whole medical system of Anthroposophic Medicine. They are manufactured according to Good Manufacturing Practice and national pharmaceutical regulations and have an excellent safety status; the available evidence suggests clinical benefits. Current pharmaceutical regulation of anthroposophic medicinal products in the EU and most European countries does not take the special properties of these products sufficiently into account. Future policies should focus on appropriate ways of addressing regulatory challenges to anthroposophic medicinal products.