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Notice of the General Office of the China Food and Drug Administration on the Work concerning the Implementation of the Decision of the State Council on Cancelling the Third Group of Administrative Licensing Items Designated by the Central Government for Implementation by Local Governments [Effective]
国家食品药品监管总局办公厅关于落实《国务院第三批取消中央指定地方实施行政许可事项的决定》有关工作的通知 [现行有效]
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Notice of the General Office of the China Food and Drug Administration on the Work concerning the Implementation of the Decision of the State Council on Cancelling the Third Group of Administrative Licensing Items Designated by the Central Government for Implementation by Local Governments 

国家食品药品监管总局办公厅关于落实《国务院第三批取消中央指定地方实施行政许可事项的决定》有关工作的通知

(No. 46 [2017] of the General Office of the China Food and Drug Administration) (食药监办法〔2017〕46号)

Food and drug administrations of all provinces, autonomous regions, and municipalities directly under the Central Government and the Food and Drug Administration of Xinjiang Production and Construction Corps: 各省、自治区、直辖市食品药品监督管理局,新疆生产建设兵团食品药品监督管理局:
On January 21, 2017, the State Council issued the Decision of the State Council on Cancelling the Third Group of Administrative Licensing Items Designated by the Central Government for Implementation by Local Governments (No. 7 [2017], State Council), which cancelled three administrative licensing items: the approval of registration of pharmaceutical excipients (excluding new and imported ones), the preliminary examination of the accreditation of institutions for drug clinical trials as well as the approval of Internet-based pharmaceutical trading service enterprises (excluding third-party platforms) by provincial food and drug administrative departments. In order to implement the relevant requirements for canceling the administrative licensing items, and effectively complete the implementation and transition of the interim and ex post supervision measures, you are hereby notified of relevant issues as follows: 2017年1月21日,国务院发布了《第三批取消中央指定地方实施行政许可事项的决定》(国发〔2017〕7号),取消了由省级食品药品监管部门实施的药用辅料(不含新药用辅料和进口药用辅料)注册审批、药物临床试验机构资格认定初审、互联网药品交易服务企业审批(第三方平台除外)三项行政许可事项。为了落实取消行政许可事项的相关要求,做好事中事后监管措施的落实和衔接工作,现就有关事项通知如下:
I. Cancellation of the approval of registration of pharmaceutical excipients (excluding new and imported ones) by provincial food and drug administrative departments   一、关于取消省级食品药品监管部门实施的药用辅料(不含新药用辅料和进口药用辅料)注册审批
The provincial food and drug administrative departments shall complete the related review and approval of pharmaceutical excipients, and effectively conduct the work such as on-site inspection and sampling of domestic high-risk pharmaceutical excipients in accordance with the Announcement on Matters concerning the Related Review and Approval of Drug Packaging Materials, Pharmaceutical Excipients, and Drugs (No. 134 [2016]). They shall effectively strengthen the routine supervision over the manufacturers of pharmaceutical excipients, and intensify the extended inspection on pharmaceutical excipients so as to guarantee the quality of drugs. 各省级食品药品监管部门应按照《关于药包材药用辅料与药品关联审评审批有关事项的公告》(2016年第134号)要求,落实药用辅料关联审评审批工作,做好国产高风险药用辅料的现场核查、抽样等工作。要切实加强对药用辅料生产企业的日常监管,强化对药用辅料的延伸检查,保证药品质量。
II. Cancellation of the preliminary examination of the accreditation of institutions for drug clinical trials by provincial food and drug administrative departments   二、关于取消省级食品药品监管部门实施的药物临床试验机构资格认定初审
...... 药物临床试验机构资格认定和复核检查由食品药品监管总局(以下简称总局)受理,申请资料中无需提交省级卫生行政部门和省级食品药品监管部门审核意见。申请人分别登陆总局药物临床试验机构资格认定电子申请系统和复核检查系统,按要求填报申请书和申请材料,纸质资料寄至总局核查中心,总局形式审查后将书面通知申请人是否受理。现场检查和审核的结果将书面通知申请人,总局对通过资格认定的申请人情况进行公告并颁发证书。
 ......



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