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(2015-01-23)[2015-02-03]http://www.sda.gov.cn/WS01/CL0844/113340.html各省、自治区、直辖市食品药品监督管理局:根据药品不良反应评估结果,为控制药品使用风险,决定对独一味口服制剂说明书进行修订。现请将如下事项通知行政区域内生产企业,并督促尽快完成:一、在2015年4月30日前,依据《药品注册管理办法》等有关规定提出修订说明书的补充申请报备案。
(2015-01-23) [2015-02-03] http://www.sda.gov.cn/WS01/CL0844/113340.html Food and Drug Administrations of all provinces, autonomous regions and municipalities directly under the Central Government: According to the assessment results of adverse drug reactions , In order to control the risk of drug use, decided to amend the unique flavor of oral preparation instructions. Please notify the manufacturer of the administrative area below and urge it to be completed as soon as possible: 1. Before April 30, 2015, a supplementary application for revising the application will be submitted according to the relevant provisions of the “Measures for the Administration of Drug Registration.”