见,药物警戒所涉及的不仅是药物的不良反应,还涉及与药物相关的其它问题如下: 低于法定标准的药品 ( substandard medicines ) 用药失误( medication errors ) 缺乏疗效的报告( lack of efficacy reports ) 药品用于无充分科学依据并未经核准..
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不合标准的食品和药品 substandard food and medicine
对于已有国家标准的药品,可只检测系统适用性试验。
As for national standard drugs, system suitability shall be tested only.
申请已有国家标准的药品注册,一般不需要进行临床研究。
Generally, it is not necessary to conduct clinical study for the application for registration of drugs with existing state standards.
已有国家标准药品的申请,是指生产已经由国家药品监督管理局颁布的正式标准的药品注册申请。
Application for drugs with existing state standards shall refer to the application for registration of the drugs for which the SDA has promulgated official standards.
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