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Decision of the China Food and Drug Administration on Matters concerning Adjusting the Registration Administration of Imported Drugs [Effective]
国家食品药品监督管理总局关于调整进口药品注册管理有关事项的决定 [现行有效]
【法宝引证码】

Order of the China Food and Drug Administration 

国家食品药品监督管理总局令

(No. 35) (第35号)

The Decision of the China Food and Drug Administration on Matters concerning Adjusting the Registration Administration of Imported Drugs, as deliberated and adopted at the executive meeting of the China Food and Drug Administration on June 20, 2017, is hereby issued and shall come into force on the date of issuance. 《国家食品药品监督管理总局关于调整进口药品注册管理有关事项的决定》已于2017年6月20日经国家食品药品监督管理总局局务会议审议通过,现予公布,自公布之日起施行。
Director: Bi Jingquan 局长:毕井泉
October 10, 2017 2017年10月10日
Decision of the China Food and Drug Administration on Matters concerning Adjusting the Registration Administration of Imported Drugs 国家食品药品监督管理总局关于调整进口药品注册管理有关事项的决定
In accordance with the requirements of the Decision of the Standing Committee of the National People's Congress on Authorizing the State Council to Conduct the Pilot Program of the System of Drug Marketing License Holders in Certain Areas and Relevant Issues and the Opinions of the State Council on Reforming the Examination and Approval System for Drugs and Medical Devices (No. 44 [2015], State Council), and for the purpose of encouraging the marketing of new drugs and satisfying clinical demand, it has been decided upon deliberation at the executive meeting of the China Food and Drug Administration that the matters on the registration administration of imported drugs shall be adjusted as follows:
......
 根据《全国人民代表大会常务委员会关于授权国务院在部分地方开展药品上市许可持有人制度试点和有关问题的决定》《国务院关于改革药品医疗器械审评审批制度的意见》(国发〔2015〕44号)要求,为鼓励新药上市,满足临床需求,经国家食品药品监督管理总局局务会议研究决定,对进口药品注册管理有关事项作如下调整:
......

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