[Significance of herbal/botanical monograph in international registration of Chinese medicine].

ABSTRACT

Herbal/botanical monograph, first emerging abroad, includes the scientific conclusions on safety and effectiveness of herbal medicine/botanical medicine, as it is often compiled by drug regulatory authorities. It is designed to unify the related technologies in this field and evaluation standards for review. Thus, herbal/botanical monograph is vital for the internationalization of Chinese medicine and being inscribed into the herbal/botanical monograph of target country is the first step for drug registration there. At the moment, there are few domestic studies on international herbal/botanical monographs, let alone the importance of the monographs in international registration of Chinese medicine preparations. This study first described international monographs on herbal/botanical medicine, then discussed the similarities and differences between international monographs and Chinese Pharmacopoeia, and finally analyzed the significance and value of the monographs in the international registration of Chinese medicine. On this basis, this study underscored the research on herbal/botanical monographs of key candidate countries for Chinese medicine registration, with a view to enhancing international recognition and laying the foundation for international registration and related policy formulation.