A'simplified'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 pro...A'simplified'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.展开更多
Traditional herbal medicine(THM)is an important part of the traditional Chinese medicine culture.Due to its high medicinal potential,it should not only serve for the Chinese people’s medical use,but also contribute t...Traditional herbal medicine(THM)is an important part of the traditional Chinese medicine culture.Due to its high medicinal potential,it should not only serve for the Chinese people’s medical use,but also contribute to the world medicine,THM for the international market must be standardized and large-scale,and produced according to the"Good Agriculture Practice"(GAP).The quality of THM directly affects the patient’s treatment status and safety of use.Therefore,the quality assurance of THM runs through the entire process of research and development,production and clinical practice.The standardized production and cultivation of THM is the starting point of the THM industry chain and plays a decisive role in the economic development of the THM industry.This article summarizes the development history,limitations and future development of GAP,and clarifies the opportunities for THM in the rapid development of the international and domestic Chinese medicine industry.In addition,analyzing the deficiencies that were existing in the former GAP implementation process and by suggesting science-based quality measures,it is hoped to stipulate improved GAP guidelines in the future and to lay the foundation for a modern THM international trade.展开更多
文摘A'simplified'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.
基金supported by Ministry of Agriculture and Rural Affairs of the People’s Republic of China(No.CARS-21)National Administration of Traditional Chinese Medicine(No.Finance Society[2019],39)+1 种基金National Natural Science Foundation of China(No.M1942003)National Natural Science Foundation of China(No.M2042003)。
文摘Traditional herbal medicine(THM)is an important part of the traditional Chinese medicine culture.Due to its high medicinal potential,it should not only serve for the Chinese people’s medical use,but also contribute to the world medicine,THM for the international market must be standardized and large-scale,and produced according to the"Good Agriculture Practice"(GAP).The quality of THM directly affects the patient’s treatment status and safety of use.Therefore,the quality assurance of THM runs through the entire process of research and development,production and clinical practice.The standardized production and cultivation of THM is the starting point of the THM industry chain and plays a decisive role in the economic development of the THM industry.This article summarizes the development history,limitations and future development of GAP,and clarifies the opportunities for THM in the rapid development of the international and domestic Chinese medicine industry.In addition,analyzing the deficiencies that were existing in the former GAP implementation process and by suggesting science-based quality measures,it is hoped to stipulate improved GAP guidelines in the future and to lay the foundation for a modern THM international trade.
