Fig. 1
From: Key quality factors for Chinese herbal medicines entering the EU market
Different roles of the EDQM and the EMA for regulation of herbal medicinal products in the EU. Within the EU, the Ph. Eur. under management of the EQDM is a legally binding document for quality standards for medicinal products. The EMA is mainly responsible for efficacy and safety of medicinal products. The combination of both institutions plays central roles in medicinal products. The different terms are used: Herbal drug (Ph. Eur.) = herbal substance (EMA); herbal medicinal product (Ph. Eur. and EMA)