Directive 2001-83-EC关于传统草药的具体规定

Detailed regulations about traditional herbal medicines in Directive 2001-83-EC

2001-83号法令是欧盟人用药物相关法令中的基本大法。该法令于2001年11月6日第一次颁布,主要是用于监管药品生产、流通、使用环节,以保证公众健康和促进药品研发。到目前为止已经修订了7次。本文依据2008年12月30日版中第三大部分内容,详细介绍了传统植物药在欧盟注册的法规要求,以期为国内的研究者、企业(申办者)及其他致力于传统中草药在欧盟注册并期望获得批准的有志者提供些许信息支持。

Directive 2001-83-EC is a primary part of the EU laws and regulations relevant to drugs used in human.The Directive 2001-83-EC published firstly in Nov.6,2001 has being used to supervise the manufacture,distribution and administration of medical products in order to protect the public health and promote drug development.Up to date,it has been revised seven times.This article,according to the third part of the Directive 2001-83-EC published in Dec.30.2008,introduces the detailed regulations about traditional herbal registration in EU.The goal is to offer information for Chinese researchers,sponsors and other persons who are interested in registering Chinese traditional medicines in EU and intend to get approval.