复方中草药进入欧洲市场的关键成功因素

Critical success factors for acceptance of multiherbal Chinese medicine in Europe

中医药是中国人民为人类贡献的宝贵财富之一。中医药在全球范围内被接受的关键是能够提供基于生物活性成分的质量控制系统作为科学证据的能力。目前现代科学技术完全可以实现中草药全产业链的标准化生产,确保药品的质量、有效性和安全性,从而打入国际市场。中草药以药品的身份进入欧盟有多种途径,但是无论哪一种选择,药物的质量都是最重要的。迄今为止,中草药成分的复杂性和其生物活性协同作用的复杂性,对药物质量控制来说仍然是一个挑战。特别是复方中草药的质量控制难度更大。系统生物学方法是一种多维化学和药理学方法,能够将复杂的中草药成分与生物活性联系起来。因此,系统生物学在中药领域的应用是中草药现代化研究领域的关键组成部分,它可以为中医的诊断和中草药的传统使用提供科学证据,从而大力提高中草药产品在全球的接受度。本文讨论了中草药特别是复方中草药进入欧洲的关键点,强调了质量标准的重要性,以及为保障质量标准的落实,执行不同类型的良好的质量管理(GXP)的重要性。同时,介绍了欧洲对植物药安全性和有效性的理解,以及采取的相应管理方法。此外,本文也为说明中草药在欧盟市场上的商业潜力,介绍了一些欧盟成员国常见疾病的OTC市场的情况,他们是注册中草药进入欧盟的主流市场,我们需要对这样的市场规模有一个准确的了解。

The treasures of Chinese medicine are important intellectual contribution to mankind.The key to worldwide acceptance of traditional Chinese medicine(TCM)is the ability to provide scientific evidence in combination with a quality control system based on bioactive ingredients.Modern technologyical tools are now available to standardize the industrial chains of TCM products.This can contribute to a high level of efficacy and safety,and facilitate the introduction into the international markets.As medicines,TCM products can enter the European Union(EU)states markets in different ways.No matter which approach is chosen,the quality of the medicines is of utmost importance.The complexity of ingredients and synergistic bioactivities of TCM makes difficult the analysis for quality control.In particular,the quality control of multi-herbal TCM products is even more difficult.The systems biology approach,a multi-dimensional chemical and pharmacological approach,can link the complex metabolic profiles of herbs with biological effects and serves as a key to quality control of TCM material medica while providing simultaneous evidence for the underlying diagnosis,efficacy and worldwide acceptance of TCM products.This paper outlines how TCM products,especially multi-herbal TCM products,can enter the EU states,and emphasizes the importance of quality standards and of the implementation of different type of Good Practices such as Good Agricultural and Collecting Practices(GACP),Good Manufactural Practices(GMP),and Good Distribution Practices(GDP).All these practices are represented as GXP to ensure fulfillment of quality standards.In addition,this paper introduces European understanding of the safety and efficacy of herbal medicines,as well as the European management system.Furthermore,in order to illustrate the commercial potential of TCM products in EU markets,the OTC markets of some common diseases in the EU member states are discussed.These markets are the mainstream ones by which TCM products can enter the EU states.This information can help us to have a correct understanding of the market size in the EU states.