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广受中国医药业关注的欧盟传统药品法于4月30日起正式生效。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。此举意味着欧盟对中药进口的政策出现了重大变化,首度承认符合条件的中药可获得药品的合法“身份”,这将对我国中药进入欧盟市场产生长远影响。
The EU Traditional Medicines Law, which is widely concerned by China’s pharmaceutical industry, came into effect on April 30. 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. This means that the EU has undergone major changes in its policy on the import of Chinese medicines. For the first time, it recognizes that eligible Chinese medicines will acquire the legal “identity” of the medicines, which will have a long-term impact on China’s entry of Chinese medicines into the EU market.