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Jiangsu Provincial Drug Administration's Implementation of Medical Devices申请人通过江苏政务服务网登录“江苏省药品监督管理局医疗器械行政审批系统”,填写申报信息,按照江苏政务服务网相关办事指南要求(详见附件),上传相关申报资料 ....Release time:2022-08-27
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The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the draft of the "Quality Management Standards for Drug Packaging Materials Production"为贯彻落实《药品管理法》《药品生产监督管理办法》,引导药包材生产企业规范生产行为,指导药品上市许可持有人履行好药包材供应商审核职责 ....Release time:2022-08-27
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Notice from the National Medical Products Administration on Issuing the Regulations on the Management of Annual Drug Reports药品年度报告制度是《药品管理法》提出的一项新制度。《药品管理法》明确规定,药品上市许可持有人应当建立年度报告制度,每年将药品生产销售、上市后研究、风险管理等情况按照规定向省、自治区、直辖市人民政府药品监督管理部门报告。 ....Release time:2022-08-27
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Announcement of the National Medical Products Administration on Further Improving the Relevant Matters of Drug Related Evaluation, Approval and Supervision (No. 56 of 2019)为落实中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(厅字〔2017〕42号) ....Release time:2019-08-08
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Notice of the Drug Evaluation Center of the National Medical Products Administration on Issuing the Technical Guidelines for Sealing Research of Chemical Drug Injection Packaging Systems (Trial) and the Technical Guidelines for Compatibility Research of Plastic Component Systems Used in Chemical Drug Injection Production (Trial) (No. 33 of 2020)指导化学药品注射剂的研发,在国家药品监督管理局的部署下 ....Release time:2020-09-30
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Notice from the Drug Evaluation Center of the National Medical Products Administration on the Release of Three Documents, including the Technical Requirements for Quality and Efficacy Consistency Evaluation of Chemical Drug Injection Generic Drugs (No. 2 of 2020)为加强对化学药品注射剂仿制药质量和疗效一致性评价工作的指导 ....Release time:2020-09-29
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Notice on the Public Solicitation of Opinions on the Management Regulations for the Evaluation and Approval of the Association between Chemical Raw Materials, Pharmaceutical Auxiliary Materials, Drug Packaging Materials and Pharmaceutical Preparations (Draft for Comments)为配合新修订《药品注册管理办法》的贯彻实施,我中心组织起草了《化学原料药、药用辅料及药包材与药品制剂关联审评审批管理规定(征求意见稿)》 ....Release time:2020-09-28
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Notice on Publicly Soliciting Opinions on the Technical Guidelines for Pharmaceutical Change Research of Listed Chemical Drugs关于公开征求《已上市化学药品药学变更研究技术指导原则》意见的通知 ....Release time:2019-09-28
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