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2003年,国家食品药品监督管理局发布施行《药物非临床研究质量管理规范》(原局令第2号),并制定了《药物非临床研究质量管理规范检查办法(试行)》。2007年,国家食品药品监督管理局对《药物非临床研究质量管理规范检查办法(试行)》进行了修订,并更名为《药物非临床研究质量管理规范认证管理办法》。2017年,国家食品药品监督管理总局制定了新的《药物非临床研究质量管理规范》(以下简称药物GLP)。
截至2021年3月2日
共有73家机构符合药物GLP要求
同时具备OECD GLP资质的实验室共有8家
接受过FDA GLP检查的机构共有12家
(在试验单位列表中标记英文名称)
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延伸阅读
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