问答

Statement: The content of this Q&A reflects the current views of CQAF, for mutual learning and exchange among industry colleagues.

按照药品管理的体外诊断试剂，是否必须开展信号检测分析评价以及上市后安全性研究工作，如必须开展，从什么角度着手比较合理？

2023-09-27 09:58:34
How can generic drug manufacturers do a good job in identifying signal detection and risk control?
2023-09-27 09:58:12
What are the practical operability of PV risk control measures, especially special risk control measures?
2023-09-27 09:57:51
风险管理计划需要药品安全委员会审核吗？

2023-09-27 09:57:29
药物安全委员会的召开频率是否必须定期？能否根据“三个重大”出现的时间灵活安排召开时间？

2023-09-27 09:56:21
Currently, there are no Phase I-III clinical trials, only BE trials. Do you need to submit a DSUR
2023-09-27 09:55:54

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