發(fā)布時間：2018-08-07 10:09

【摘要】：日本因本國嚴重的人口老齡化問題,一直非常重視發(fā)展以再生醫(yī)療為代表的創(chuàng)新醫(yī)療科技,在再生醫(yī)療高新技術(shù)產(chǎn)業(yè)的帶動下刺激醫(yī)藥經(jīng)濟發(fā)展也是"安倍經(jīng)濟學(xué)"的政策之一。日本是世界上最早通過立法建立完備的再生醫(yī)療監(jiān)管體系的國家之一。根據(jù)風(fēng)險高低對臨床再生醫(yī)療技術(shù)加以分類審批,不同于世界其他任何國家,日本率先將再生醫(yī)療制品單列為第四類醫(yī)療產(chǎn)品,獨立于藥品、醫(yī)療器械及化妝品,并根據(jù)其自身生物特性建立專門審批制度,兼顧科學(xué)性、安全性和臨床需要。立法監(jiān)管對日本再生醫(yī)療產(chǎn)業(yè)經(jīng)濟發(fā)展起到良性促進作用,對完善中國再生醫(yī)療監(jiān)管具有一定的啟示作用。
[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.
【作者單位】： 上海國際知識產(chǎn)權(quán)學(xué)院;比利時布魯塞爾自由大學(xué);
【基金】：國家建設(shè)高水平大學(xué)公派研究生項目(留金發(fā)[2015]3022號)資助 同濟大學(xué)人文社會科學(xué)跨學(xué)科研究項目“干細胞臨床治療法律與政策研究”(20141114)的階段性成果
【分類號】：D931.3;DD912.1
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本文編號：2169697