Ensuring Compliance of Raw Herbal Materials Stemmed from China with European Good Agricultural and Collection Practice / 中草药·英文版

ABSTRACT

Asimplified European procedure now allows the registration of traditional herbal medicines as medicinal products even without the support of clinical data.This procedure entails the requirement that those products comply with European Good Manufacturing Practice for medicinal products,which in turn implies that the raw herbal materials comply with the European Guidelines for Good Agricultural and Collection Practice.On the basis of a comparison between European Good Agricultural and Collection Practice and China Good Agricultural Practice,as well as direct observation made at sites in China,we issue some recommendations to facilitate good communication between the Chinese producer and European pharmaceutical customer,with a view to ensure full compliance with European expectations.