Ensuring Compliance of Raw Herbal Materials Stemmed from China with European Good Agricultural and Collection Practice
10.3969/j.issn.1674-6384.2011.04.003
- Author:
Philippe ANDRE
;
Haobo SU
;
Wenyuan GAO
- Publication Type:Journal Article
- Keywords:
China Good Agricultural Practice;
Europe Good Agricultural Practice;
Good Agricultural and Collection Practice;
medicinal products;
raw herbal materials
- From:
Chinese Herbal Medicines
2011;(4):247-252
- CountryChina
- Language:Chinese
-
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.