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4月30日,欧盟在官方网站公布《欧洲传统植物药注册程序指令》(编号2004-24-EC,以下简称“《指令》”),并宣布自公布之日起生效。据了解,与两年前《指令(草案)》的内容相比,该指令大幅降低了植物药市场准入条件。 商务部科技司副司长单庆江介绍说,多年来,我国中草药制成品只能以食品和医药原料的名义进入欧盟市场,一直未获得药品的合法“身份”。 近年来,欧洲社会对传统植物药疗效的认同感有所增强,对中药的需求呈上升趋势。为适应新形势,欧盟于2002年1月17日正式对外公布了《指令(草案)》,在征求意见后提交欧洲议会和欧盟理事会审议通过后颁布。
On April 30, the EU promulgated the Directive on the Registration of Traditional Botanicals in Europe (No. 2004-24-EC, hereinafter referred to as the “Directive”) on the official website and declared effective as of the date of its promulgation. It is understood that, compared with the contents of the “Directive (Draft)” two years ago, the directive drastically reduced the market entry requirements for the plant medicine market. Shan Qingjiang, deputy director of the Department of Science and Technology of the Ministry of Commerce, said that over the years, China’s manufactured herbal products have only entered the EU market in the name of foodstuffs and pharmaceutical raw materials and have never obtained the legal status of the drug. In recent years, the recognition of the curative effect of traditional botanicals in European society has been enhanced, and the demand for traditional Chinese medicines has been on the rise. In order to adapt to the new situation, the EU formally announced the “Directive (Draft)” on January 17, 2002, which was promulgated after consultation with the European Parliament and the EU Council for comment.