(英文)韩国干细胞治疗的监管问题：疗效或效率？.pdf

下载文档

37
0
约1.5万字
约 3页
2017-05-30 发布于河南
举报
版权申诉
保障服务

(英文)韩国干细胞治疗的监管问题：疗效或效率？.pdf

1、本文档共3页，可阅读全部内容。
2、原创力文档（book118）网站文档一经付费（服务费），不意味着购买了该文档的版权，仅供个人/单位学习、研究之用，不得用于商业用途，未经授权，严禁复制、发行、汇编、翻译或者网络传播等，侵权必究。
3、本站所有内容均由合作方或网友上传，本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺！文档内容仅供研究参考，付费前请自行鉴别。如您付费，意味着您自己接受本站规则且自行承担风险，本站不退款、不进行额外附加服务；查看《如何避免下载的几个坑》。如果您已付费下载过本站文档，您可以点击这里二次下载。
4、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等，请点击“版权申诉”（推荐），也可以打举报电话：400-050-0827(电话支持时间：9:00-18:30)。

(英文)韩国干细胞治疗的监管问题：疗效或效率？

/10.5045/kjh.207 The Korean Journal of Hematology Volume 47 ㆍNumber 2 ㆍJune 2012 Perspective Regulatory issues in stem cell However, there are also significant controversies regarding the simplification of the authorization process for cell therapeutics in Korea: efficacy or therapeutics. efficiency? SIGNIFICANCE OF CLINICAL TRIALS IN THE AUTHOR- IZATION OF CELL THERAPY PRODUCTS Il-Hoan Oh, M.D., Ph.D. Generally, the companies that develop cell therapeutics are requested to file the documents regarding the safety Catholic High-Performance Cell Therapy Center, Research and efficacy of their products in order to obtain approval Center for Stem Cell Therapeutics Evaluation, The Catholic for market sales. Then, the validity of the cell product as University of Korea, Seoul, Korea a drug is examined by a government inspect