药物非临床研究质量管理规范 导航菜单

药物分析


药物丹麦美国食品和药品管理局美国环境保护署中华人民共和国




药物非临床研究质量管理规范(Good Laboratory Practice, GLP),又称良好药品实验研究规范,是指导科研机构研制安全、有效的药物的指令性文件,旨在确保研究实验的质量和实验数据的可靠,以及实验的安全性。


1973年,丹麦制定了世界上首部GLP,但影响不大。美国食品和药品管理局于1976年1月19日颁布了GLP,并于1979年6月20日生效。1983年,美国环境保护署也颁布了自己的GLP。此后,许多国家纷纷制定自己的强制性GLP规定。


中华人民共和国在多年沿用美国技术标准之后,于1994年参照美国GLP制定了自己的GLP,并于1999年加以修订。







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