Ensuring Compliance of Raw Herbal Materials Stemmed from China with European Good Agricultural and Collection Practice

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.

Future development of Good Agricultural Practice in China under globalization of traditional herbal medicine trade

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.

金荞麦采收SOP探讨与研究

目的:探索中药材金荞麦采收规律,指导金荞麦采收SOP制定。方法:结合太极集团原料生产基地建设的特点,总结归纳金荞麦采收现状,分析采收时间和期限对金荞麦品质质量和产量的相关影响。结果与结论:金荞麦采收的时间性是影响金荞麦品质质量的关键因素,金荞麦采收SOP制定须明确金荞麦的最佳采收期,要坚持“适时适度、优质高产”的基本准则。

中药材GAP基地建设现状及发展策略

中药材GAP是整个中药生产质量控制的源头,为保证中药材或天然药物的安全、有效及质量可控,国际上正在积极探索GAP的实施。中药材GAP推行十多年来影响深远,中药材规模化种植面积不断扩大。但中药材GAP基地产出的药材尚不能完全满足市场需求,中药材的产量和质量有待进一步提高。该文总结了我国中药材GAP基地建设现状,GAP实施期间通过认证的129家企业共包含196个中药材GAP基地,形成了以四川省、云南省、吉林省、河南省、山东省等为核心的中药材GAP基地规模化建设区。我国中药材GAP基地总面积25万~50万亩(1亩≈667 m^(2)),尚不足中药材种植总面积的1%。国际范围内的农业生产质量管理策略均属于市场化行为,借鉴国际药用植物种植和采收质量管理规范(GACP)和危害分析和关键控制点(HACCP),参考我国中药材质量管理的相关政策,就中药材GAP的进一步推行提出可行性建议:①尊重市场规律,借鉴国际经验推动中药材GAP管理,推动第三方实施中药材GAP认证;②推行HACCP管理体系,修订中药材GAP,促进中药材GAP管理良性发展;③加强政策与标准的执行,促进中药材质量全程追溯体系建设,助力中药材优质优价。