日本再生医疗法律制度述评
发布时间：2018-08-07 10:09
【摘要】：日本因本国严重的人口老龄化问题,一直非常重视发展以再生医疗为代表的创新医疗科技,在再生医疗高新技术产业的带动下刺激医药经济发展也是"安倍经济学"的政策之一。日本是世界上最早通过立法建立完备的再生医疗监管体系的国家之一。根据风险高低对临床再生医疗技术加以分类审批,不同于世界其他任何国家,日本率先将再生医疗制品单列为第四类医疗产品,独立于药品、医疗器械及化妆品,并根据其自身生物特性建立专门审批制度,兼顾科学性、安全性和临床需要。立法监管对日本再生医疗产业经济发展起到良性促进作用,对完善中国再生医疗监管具有一定的启示作用。
[Abstract]:Because of its serious problem of aging population, Japan has always attached great importance to the development of innovative medical science and technology represented by regenerative medicine. It is also one of the policies of Abenomics to stimulate the development of medicine economy under the impetus of regenerative medical high-tech industry. Japan is one of the earliest countries in the world to establish a complete regulatory system of regenerative health care through legislation. Different from any other country in the world, Japan has taken the lead in classifying the regenerated medical products as the fourth category of medical products, independent of drugs, medical devices and cosmetics. A special examination and approval system is established according to its biological characteristics, which takes into account scientific, safety and clinical needs. Legislative supervision plays a positive role in promoting the economic development of Japan's regenerative medical industry, and has a certain enlightening effect on improving the supervision of regenerative medical treatment in China.
【作者单位】： 上海国际知识产权学院;比利时布鲁塞尔自由大学;
【基金】：国家建设高水平大学公派研究生项目(留金发[2015]3022号)资助 同济大学人文社会科学跨学科研究项目“干细胞临床治疗法律与政策研究”(20141114)的阶段性成果
【分类号】：D931.3;DD912.1
，
本文编号：2169697
[Abstract]:Because of its serious problem of aging population, Japan has always attached great importance to the development of innovative medical science and technology represented by regenerative medicine. It is also one of the policies of Abenomics to stimulate the development of medicine economy under the impetus of regenerative medical high-tech industry. Japan is one of the earliest countries in the world to establish a complete regulatory system of regenerative health care through legislation. Different from any other country in the world, Japan has taken the lead in classifying the regenerated medical products as the fourth category of medical products, independent of drugs, medical devices and cosmetics. A special examination and approval system is established according to its biological characteristics, which takes into account scientific, safety and clinical needs. Legislative supervision plays a positive role in promoting the economic development of Japan's regenerative medical industry, and has a certain enlightening effect on improving the supervision of regenerative medical treatment in China.
【作者单位】： 上海国际知识产权学院;比利时布鲁塞尔自由大学;
【基金】：国家建设高水平大学公派研究生项目(留金发[2015]3022号)资助 同济大学人文社会科学跨学科研究项目“干细胞临床治疗法律与政策研究”(20141114)的阶段性成果
【分类号】：D931.3;DD912.1
，
本文编号：2169697
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