On December 27th, the State Food and Drug Administration issued the “Notification on reinforcing drug supervision during the pilot of centralized procurement and use of selected drugs.” The “Notification” stipulated that each provincial drug regulatory authority should reinforce the quality supervision of the production, circulation, and use of selected drugs and the punishment for enterprises that violatie laws and regulations. The regulation authority should also urge the selected enterprises to establish a reporting system for inventory and off-production. The “Notification” indicates that the drug distribution should be regulated through related treaties to ensure the drug supply.
国家药监局发布4+7配套文件, 确保中标药品质量安全
来源:制药站 2018.12.28
核心提示:12月27日,国家药监局发布《国家药监局关于加强药品集中采购和使用试点期间药品监管工作的通知》(以下简称《通知》)。《通知》要求,各省级药品监管部门应加大对中标药品生产、流通、使用全周期的质量监管,加大违法违规企业的处罚力度,要督促中标生产企业建立企业库存和停产报告制度。《通知》指出,应通过协议规范配送行为,以保证药品供应。
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