Herbal product development
Entering the market as food supplement implies the product and health claims has to comply with the EU food laws. The so-called simplified registration for traditional herbal medicinal product, specific for Europe, or the well-established use registrations still require significant regulatory expertise. Full development with medicinal claims is open to herbal products in a similar way as for small molecules or biological products. Modified herbal products or compounds extracted from plants often classify in this latter category.
A careful evaluation of the product, intended use and claims, and pro and con’s of each route is the best first step in the development process. Kinesis Pharma has been involved in determining the best strategy for several herbal products, including fully developed medicinal products, traditional herbal medicines as well as food supplements. It has all expertise in house for evaluation and development of each of these routes.