摘要
一般来说,欧盟有关人用药品的法律皆适用于草药药品。2004年时,欧盟通过一个指令,为传统草药药品上市销售引进一个新途径,名为"简化注册"程序。在满足一定条件后,传统草药药品的注册可以无需提交有关安全性、有效性的检测和实验的数据和文件,但必须提交这些药品30年药用历史的充分证明,其中的15年是在欧盟境内。因此理论上来说,药厂申请上市销售许可时应可节省大量的金钱、时间与精力的投入。但这个新途径在实践时并不如预期般畅顺地解决问题。文章分析了多个影响草药药品(包括现代与传统在内)发展的欧盟法律,草药药品需求不断增长的原因,欧盟对最新市场趋势作出的反应,以及中国药厂应如何把握机会进入欧洲市场等问题。同时文章强调一个现实情况,就是争取中医药科研文章能在国际医学杂志上发表,将会是这行业将来得以成功发展的关键因素。
In general EU legislation on pharmaceutical products for human use also applies to herbal medicines. In 2004 EU adopted a Directive to introduce a new pathway for marketing traditional herbal medicinal products, the ＂simplified registration＂ procedure. Subject to satisfying certain conditions, it allows the registration of traditional herbal medicinal products without requiring particulars and documents on tests and trials on safety and efficacy, provided that there is sufficient evidence of a minimum 30 years medicinal use, including at least 15 years in the EU. Accordingly pharmaceutical companies should to be able in theory to save considerable expenditure of time, effort and money when applying for marketing authorization. But in practice the new pathway doesn＇t work out as smoothly as expected. This article analyze the various pieces of European legislation that affect the development of both modem and traditional herbal medicine, the continued growth of their demand, EU＇s response to the latest market trend, and how Chinese herbal medicine companies should grasp the opportunities to penetrate into the European market. It also stresses the fact that publication of Chinese medicine scientific research articles in international medical journals will be the key to the sector＇s future success.
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2009年第6期812-818,共7页
China Journal of Traditional Chinese Medicine and Pharmacy
关键词
欧盟药品法
传统草药
简化注册
市场销售许可
发表医学研究
EU pharmaceutical legislation
Traditional herbal medicine
Simplified registration
Marketingauthorization
Medical research publication
