EMA published 2 updates of guidelines related to (traditional) herbal medicinal products:
- Specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products: This document addresses specifications, i.e. those tests, procedures, and acceptance criteria used to assure the quality of the herbal substances/preparations and herbal medicinal products at release and during the shelf-life. This guidance document provides general principles on the setting and justification of a uniform set of specifications to support applications for marketing authorisation or registration.
- Guideline on quality of herbal medicinal products/traditional herbal medicinal products: This document intends to cover the general quality aspects of herbal medicinal products for human and veterinary use, including traditional herbal medicinal products for human use. It describes the special problems of herbal medicinal products and the differences between medicinal products containing chemically defined active substances.
Both documents should be read in conjunction with each other.