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国卫办科教发[2015]46号各省、自治区、直辖市卫生计生委、食品药品监管局,新疆生产建设兵团卫生局、食品药品监管局,国家卫生计生委直属有关单位,食品药品监管总局直属有关单位:为加强我国干细胞制剂和临床研究质量管理,国家卫生计生委与食品药品监管总局根据《干细胞临床研究管理办法(试行)》,共同组织制定了《干细胞制剂质量控制及临床前研究指导原则(试行)》(可从国家卫生计生委或食品药品监管总局网站下载)。现印发给你们,请遵照执行。2015年7月31日
State Education Office [2015] No. 46 Health and Family Planning Commission of various provinces, autonomous regions and municipalities directly under the Central Government, Food and Drug Administration, Xinjiang Production and Construction Corps Health Bureau, Food and Drug Administration, the State Health and Family Planning Commission directly under the relevant units, the Food and Drug Administration directly under the Unit: In order to strengthen the quality control of stem cell preparations and clinical research in China, the State Health and Family Planning Commission and the State Food and Drug Administration jointly formulated and promulgated the Guidelines for Quality Control and Preclinical Studies of Stem Cell Preparations under the Measures for the Management of Stem Cell Clinical Research (Trial) Trial) "(available from the National Health and Family Planning Commission or the Food and Drug Administration Web site). Is issued to you, please follow. July 31, 2015