中草药注册法律比较研究
发布时间：2019-06-27 09:31
【摘要】：《欧盟传统草药法令》(2004/24/EC)的颁布与实施，一方面从法律角度承认了传统草药的药品地位，为我国中成药通过传统草药简化注册申请途径加以注册并以药品的形式进入欧盟市场提供了可能；但另一方面该法令设置的种种限制迫使我国中成药2011年4月30日如还未成功注册将不仅不能以目前保健品、食品添加剂等形式继续销售，而且还会被迫退出欧盟市场。如今，7年宽限期已经到期，中国中草药企业至今为止没有一家通过欧盟注册，欧盟作为中药出口的中药市场之一，如果我国中草药企业的产品不能通过注册上市将对我国中药行业产生巨大的影响。 本文以《欧盟传统草药法令》(2004/24/EC)的正式实施为切入点，结合中草药在国际注册中所遇到的问题和所处的局面，通过对欧盟及其各国、美国、日本、澳大利亚和香港等其他国家和地区的中草药和传统植物药注册的相关法规与中国相应的法规和政策进行比较和分析，其中主要对各国中草药注册法规中关于申请类别、审批程序、申报资料等相关法条进行对比分析，从而针对我国中草药境外注册过程中的难点针提出相应的应对策略略和法律建议；本文尝试将国民待遇原则引入到中草药传统使用证据效力上，以使发达国家承认而符合其使用年限的规定进而获得注册；本文通过对欧美等国家和地区关于中草药注册的相关法律定性为中草药国际贸易技术壁垒并对其进行法律分析，结合相关的世界贸易规则对这一壁垒提供相应的对策和法律解决方案。通过对各国家和地区中草药注册法规的比较和分析，给我国中草药知识产权保护和注册法规提供相应的立法建议，，从而加速我国中草药的国际化和现代化进程。
[Abstract]:The promulgation and implementation of the European Union traditional Herbal Medicine Act (2004/24/EC), on the one hand, recognizes the drug status of traditional herbal medicine from the legal point of view, which provides the possibility for Chinese proprietary medicine to register through the simplified registration application of traditional herbal medicine and enter the EU market in the form of drugs; On the other hand, the restrictions imposed by the decree will force China's proprietary Chinese medicine to be not only unable to continue to sell in the form of current health products and food additives, but also forced to withdraw from the EU market if it is not successfully registered on April 30, 2011. Now, the seven-year grace period has expired, so far none of the Chinese herbal medicine enterprises have been registered through the European Union. As one of the traditional Chinese medicine markets exported by traditional Chinese medicine, if the products of Chinese herbal medicine enterprises can not be registered and listed, it will have a great impact on China's traditional Chinese medicine industry. Based on the formal implementation of the European Union traditional Herbal Medicine Act (2004/24/EC), combined with the problems encountered in the international registration of Chinese herbal medicine and the situation in which it is located, this paper compares and analyzes the relevant laws and regulations of Chinese herbal medicine and traditional plant medicine registration in other countries and regions, such as the European Union and its countries, the United States, Japan, Australia, Hong Kong and other countries and regions, and the corresponding laws and policies in China. Among them, the application categories, examination and approval procedures, declaration materials and other relevant laws and regulations in the registration laws and regulations of Chinese herbal medicine are compared and analyzed, and the corresponding countermeasures and legal suggestions are put forward in view of the difficulties in the process of overseas registration of Chinese herbal medicine. This paper attempts to introduce the principle of national treatment into the evidentiary effect of the traditional use of Chinese herbal medicine in order to make the developed countries recognize and conform to the provisions of their useful life and then obtain registration. In this paper, the relevant laws on the registration of Chinese herbal medicine in Europe and the United States and other countries and regions are characterized as technical barriers to international trade of Chinese herbal medicines and legal analysis, combined with the relevant world trade rules to provide corresponding countermeasures and legal solutions to this barrier. Through the comparison and analysis of the registration laws and regulations of Chinese herbal medicine in various countries and regions, this paper provides corresponding legislative suggestions for the protection and registration of intellectual property rights of Chinese herbal medicine, so as to accelerate the internationalization and modernization of Chinese herbal medicine.
【学位授予单位】：华南理工大学
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：D997.1;F203;R-051
本文编号：2506681
[Abstract]:The promulgation and implementation of the European Union traditional Herbal Medicine Act (2004/24/EC), on the one hand, recognizes the drug status of traditional herbal medicine from the legal point of view, which provides the possibility for Chinese proprietary medicine to register through the simplified registration application of traditional herbal medicine and enter the EU market in the form of drugs; On the other hand, the restrictions imposed by the decree will force China's proprietary Chinese medicine to be not only unable to continue to sell in the form of current health products and food additives, but also forced to withdraw from the EU market if it is not successfully registered on April 30, 2011. Now, the seven-year grace period has expired, so far none of the Chinese herbal medicine enterprises have been registered through the European Union. As one of the traditional Chinese medicine markets exported by traditional Chinese medicine, if the products of Chinese herbal medicine enterprises can not be registered and listed, it will have a great impact on China's traditional Chinese medicine industry. Based on the formal implementation of the European Union traditional Herbal Medicine Act (2004/24/EC), combined with the problems encountered in the international registration of Chinese herbal medicine and the situation in which it is located, this paper compares and analyzes the relevant laws and regulations of Chinese herbal medicine and traditional plant medicine registration in other countries and regions, such as the European Union and its countries, the United States, Japan, Australia, Hong Kong and other countries and regions, and the corresponding laws and policies in China. Among them, the application categories, examination and approval procedures, declaration materials and other relevant laws and regulations in the registration laws and regulations of Chinese herbal medicine are compared and analyzed, and the corresponding countermeasures and legal suggestions are put forward in view of the difficulties in the process of overseas registration of Chinese herbal medicine. This paper attempts to introduce the principle of national treatment into the evidentiary effect of the traditional use of Chinese herbal medicine in order to make the developed countries recognize and conform to the provisions of their useful life and then obtain registration. In this paper, the relevant laws on the registration of Chinese herbal medicine in Europe and the United States and other countries and regions are characterized as technical barriers to international trade of Chinese herbal medicines and legal analysis, combined with the relevant world trade rules to provide corresponding countermeasures and legal solutions to this barrier. Through the comparison and analysis of the registration laws and regulations of Chinese herbal medicine in various countries and regions, this paper provides corresponding legislative suggestions for the protection and registration of intellectual property rights of Chinese herbal medicine, so as to accelerate the internationalization and modernization of Chinese herbal medicine.
【学位授予单位】：华南理工大学
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：D997.1;F203;R-051
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