美国FDA警告信中的数据可靠性缺陷分析及对我国药品监管的启示

美国FDA警告信中的数据可靠性缺陷分析及对我国药品监管的启示(5)

http://www.100md.com 2019年7月25日《上海医药》 2019年第21期

[5] U.S. Department of Health and Human Services， Food and Drug Administration， Center for Drug Evaluation and Research， et al. Data integrity and compliance with drug cGMP. Questions and answers. Guidance for industry[EB/OL]. (2018-12) [2019-03-25]. https：//www.fda.gov/ media/119570/download.

[6] EMA. Guidance on good manufacturing practice and good distribution practice： questions and answers [EB/OL].(2016-08-01) [2019-03-25]. https：//www.ema.europa.eu/ en/human-regulatory/research-development/compliance/ good-manufacturing-practice/guidance-good-manufacturingpractice-good-distribution-practice-questions-answers. ......

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