四川中成药叩开欧盟大门 实现我国中药领域零突破

四川中成药叩开欧盟大门 实现我国中药领域零突破
http://world.newssc.org/system/2012/03/29/013488218.shtml
【 2012-03-29 17:15 】
【来源： 四川新闻网 】

　　记者从四川有关部门获悉，近日，由四川成都地奥制药集团有限公司研制生产的知名中药品种“地奥心血康胶囊”成功以治疗性药品身份，通过在荷兰健康保护检查局的注册(注册号：RVG102142)，获得在该国上市许可，成为我国首个进入欧盟主流医药市场的治疗性中成药品种，标志着中药国际化工作取得突破性进展。
　　据了解，“地奥心血康胶囊欧盟注册研究”在“十五”、“十一五”期间均获得国家科技部“创新药物与中药现代化”专项和国际科技合作计划的支持，是四川省推进中药现代化和国际化的重点项目。同时，四川省科技支撑计划和国际科技合作计划也予以了大力支持。经过十年努力，“地奥心血康胶囊”终于在荷兰注册成功。由于欧盟国家药政管理基本一致，进入一个成员国后再进入其他国家仅存在程序问题，此次“地奥心血康胶囊”的成功注册，填补了我国具有自主知识产权的治疗性药物进入欧洲主流医药市场的空白，实现了我国中药领域一个零的突破，将为我国中药产品进军欧盟市场起到示范作用。

　　“地奥心血康胶囊”是国家中药保护品种和国家基本药物，具有完全自主知识产权。经过20多年的市场检验，其优良的疗效和安全性得到了充分验证。2011年产品年销售收入达5.6亿元，进入欧盟市场后，预计2012年产品销售将有重大突破。(通讯员 王月婷 赵蝶)

英文原文：
http://www.cbg-meb.nl/CBG/en/hum ... n_Union/default.htm

March 22, 2012 - First Authorisation of Traditional Herbal Medicine from outside the European Union
On 14 March 2012, the Dutch Medicines Evaluation Board (MEB) for the first time in the European Union granted a marketing authorisation to a herbal medicinal product based on traditional use, manufactured in Chengdu, China.

The application was evaluated very carefully on the basis of pharmaceutical quality, safety and the justification of traditional use. The EU Directive on traditional herbal medicines stipulates that a period of at least 30 years of medicinal use, including 15 years of use in the EU, has to be justified. This means that herbal medicinal products manufactured outside the EU can also comply with the European requirements for traditional herbal medicines.

The assessment of this herbal medicinal product was not an easy task for the MEB: on the one hand, the evaluation of the scientific data in the application dossier needs to be based on the legal requirements for quality, safety and the justification of the indication based on traditional use. On the other hand many of these herbal products are on the market, including those which are manufactured outside the European Union. Patients and consumers can now benefit from the clarity provided by registration. They can be sure that for this herbal medicinal product, there has been a careful evaluation of quality, benefits and risks.

With this registration, the MEB does not give an opinion about the principles of Traditional Chinese Medicine (TCM).

The herbal medicinal product Diao Xin Xue Kang capsules, manufactured by Diao Chengdu Pharmaceuticals in China, is marketed in the Netherlands by SUBiomedicine, Zeist. Diao Xin Xue Kang capsules contain a dry extract of rhizomes of Dioscorea nipponica Makino (Japanese Yam).

Traditional herbal medicinal products are based on long-term marketing experience and are characterised in the European Directive (2001/83/EC) on human medicinal products as:

Herbal medicinal products with an indication which guarantees a safe use, in particular that it can be used without the supervision of a medical doctor. The registered indication for Diao Xin Xue Kang capsules is: “traditional herbal medicinal product used for the relief of headache and pain and cramps in the muscles of neck, back and legs. Based on long-term experience and not based on clinical evidence.” (for the official Summary of Product Characteristics reference is made to the Dutch SPC, which can be obtained from the Medicines Data Bank)
Herbal medicinal products used with a specific strength and posology. Therefore, the authorisation of Diao Xin Xue Kang can not be compared with the supply of Chinese herbal mixtures. The specifications of Diao Xin Xue Kang are established in detail in the marketing authorisation dossier.
Demonstration of a tradition of medicinal use with Dioscorea nipponica rhizome of more than 30 years, including at least 15 years in the European Union. The manufacturer has submitted sufficient scientific data on safety tests, which have been evaluated. In addition, at the time of release on the market, the marketing authorisation holder is obliged to implement a pharmacovigilance system which complies with European requirements.
The manufacturing site of Diao in Chengdu, China has undergone an inspection on Good Manufacturing Practice, carried out by the Dutch Pharmaceutical Inspection.
More information
SPC Diao Xin Xue Kang capsules, March 2012 (in Dutch)
3 May 2011 -  European Directive on Traditional Herbal Medicines Takes Effect on 1 May 2011

沙发，开始了，就吹吧。任重而道远

看样子以后还会涨价

有这回事？

好的开始是成功的一半，HP辛苦了

好品种会越来越多

我关心的是这个在荷兰怎么验证的啊，根据欧盟的法规？

欧洲人都知道变通的接受神奇的中药，可是中国人自己却要灭了中医药。
看到这条消息，也许可以给某些言论以反驳。