赵静1,
王蕾2,
刘济宁2,
韦洪莲1
1. 生态环境部固体废物与化学品管理技术中心, 北京 100029;
2. 生态环境部南京环境科学研究所, 南京 210042
作者简介: 葛海虹(1980-),女,硕士,高级工程师,研究方向为GLP实验室监管和化学品环境管理政策研究等,E-mail:gehaihong@meescc.cn.
基金项目: 生态环境部化学品污染防治项目（2110304）中图分类号: X171.5
General Situation and Enlightenment of International GLP Regulatory System for Chemicals
Ge Haihong1,Zhao Jing1,
Wang Lei2,
Liu Jining2,
Wei Honglian1
1. Solid Waste and Chemicals Management Center, Ministry of Ecology and Environment, Beijing 100029, China;
2. Nanjing Institute of Environmental Sciences, Ministry of Ecology and Environment, Nanjing 210042, China
CLC number: X171.5
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摘要:良好实验室规范（Good Laboratory Practice，GLP）自20世纪70年代建立以来，主要用于规范非临床健康与环境安全性测试的实施，确保测试数据质量，促进数据互认。目前，全球已有30多个国家或组织建立了相应的GLP管理法规、监管计划和检查手册等来指导相关机构建立和遵守GLP法规。我国相关部门建立了相应的GLP监管体系，但是化学品GLP监管体系因上位法的缺失，监管体系尚不健全，需要借鉴发达国家化学品GLP体系建设经验，结合国内化学品管理要求，提升我国GLP监管体系和监管能力。
关键词: 化学品/
GLP/
监管
Abstract:Good Laboratory Practice (GLP), established in the 1970s, is mainly used to standardize the implementation of non-clinical safety testing research, ensure the quality of research data, and promote mutual recognition and data sharing. At present, more than 30 countries or organizations have established GLP management regulations, supervision plans and supervision manuals to guide test facilities to establish GLP management system and properly comply with GLP regulations. In China, the regulatory authority has established corresponding GLP regulatory system. However, the chemical GLP regulatory system is still imperfect as the reason of lack of higher-level law. Therefore, it is necessary to learn from the experience of the developed countries to improve the GLP regulatory system and supervision ability in China.
Key words:chemicals/
GLP/
regulation.
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