国际化学品GLP监管体系发展概况与启示

葛海虹; 赵静; 王蕾; 刘济宁; 韦洪莲

doi:10.7524/AJE.1673-5897.20200207001

生态毒理学报

国际化学品GLP监管体系发展概况与启示

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葛海虹, 赵静, 王蕾, 刘济宁, 韦洪莲. 国际化学品GLP监管体系发展概况与启示[J]. 生态毒理学报, 2020, 15(3): 11-20. doi: 10.7524/AJE.1673-5897.20200207001

引用本文:

葛海虹, 赵静, 王蕾, 刘济宁, 韦洪莲. 国际化学品GLP监管体系发展概况与启示[J]. 生态毒理学报, 2020, 15(3): 11-20. doi: 10.7524/AJE.1673-5897.20200207001

Ge Haihong, Zhao Jing, Wang Lei, Liu Jining, Wei Honglian. General Situation and Enlightenment of International GLP Regulatory System for Chemicals[J]. Asian Journal of Ecotoxicology, 2020, 15(3): 11-20. doi: 10.7524/AJE.1673-5897.20200207001

Citation:

Ge Haihong, Zhao Jing, Wang Lei, Liu Jining, Wei Honglian. General Situation and Enlightenment of International GLP Regulatory System for Chemicals[J]. Asian Journal of Ecotoxicology, 2020, 15(3): 11-20. doi: 10.7524/AJE.1673-5897.20200207001

国际化学品GLP监管体系发展概况与启示

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

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
Fund Project:

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。
- 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.
- chemicals /
- GLP /
- regulation

United States Environmental Protection Agency (US EPA). Part 160-Good Laboratory Practice Standards[S]. Washington DC:Office of Pollution Prevention and Toxics, 1989

United States Environmental Protection Agency (US EPA). Part 792-Good Laboratory Practice Standards[S]. Washington DC:Office of Pesticide Programs, 1989

United States Environmental Protection Agency (US EPA). Good Laboratory Practice Standards Inspection Manual[S]. Washington DC:Office of Pollution Prevention and Toxics, 1993

United States Environmental Protection Agency (US EPA). Enforcement Response Policy (ERP) for the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Good Laboratory Practices (GLP) Regulations[S]. Washington DC:Office of Pesticide Programs, 1985

Organization for Economic Co-operation and Development (OECD). Decision of the council concerning the mutual acceptance of data in the assessment of chemicals[C(81)30(Final)] [R/OL]. (1981-05-12)[2020-02-07]. https://legalinstruments.oecd.org/en/instruments/263

Organization for Economic Co-operation and Development (OECD). Decision-recommendation of the council on compliance with principles of good laboratory practice[C(89)87(Final)] [R/OL]. (1989-10-02)[2020-02-07]. https://legalinstruments.oecd.org/en/instruments/58

Organization for Economic Co-operation and Development (OECD). Non-OECD member countries adhering to the OECD system for mutual acceptance of chemical safety data[R]. Pairs:OECD, 1997

European Chemicals Agency (ECHA). The Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)[S/OL]. (2007-06-01)[2020-02-07]. https://www.echa.europa.eu/web/guest/regulations/reach/legislation

European Commission (EC). Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the Harmonisation of Laws, Regulations and Administrative Provisions Relating to the Application of the Principles of Good Laboratory Practice and the Verification of Their Applications for Tests on Chemical Substances (codified version)[S]. Brussel:European Commission, 2004

European Commission (EC). Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the Inspection and Verification of Good Laboratory Practice (GLP) (codified version)[S]. Brussel:European Commission, 2004

Ministry of Health, Labour and Welfare; Ministry of Economy, Trade and Industry and Ministry of the Environment. Ministerial Ordinance Specifying Items for Tests Pertaining to New Chemical Substances and Studies Pertaining to the Hazardous Properties of Priority Assessment Chemical Substances and Monitoring Chemical Substances, Ministerial Ordinance No.3[S/OL]. (2010-03-31)[2020-02-07]. https://www.env.go.jp/chemi/kagaku/seitai_index.html

Ministry of the Environment. Operation manual of chemical substance GLP concerning ecotoxicity test[EB/OL]. (2012-03-30)[2020-02-07]. https://www.env.go.jp/chemi/kagaku/seitai_index.html

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葛海虹, 赵静, 王蕾, 刘济宁, 韦洪莲. 国际化学品GLP监管体系发展概况与启示[J]. 生态毒理学报, 2020, 15(3): 11-20. doi: 10.7524/AJE.1673-5897.20200207001

引用本文:

葛海虹, 赵静, 王蕾, 刘济宁, 韦洪莲. 国际化学品GLP监管体系发展概况与启示[J]. 生态毒理学报, 2020, 15(3): 11-20. doi: 10.7524/AJE.1673-5897.20200207001

Citation:

国际化学品GLP监管体系发展概况与启示

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
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

收稿日期: 2020-02-07

基金项目:

生态环境部化学品污染防治项目（2110304）

关键词:

化学品 /
GLP /
监管

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。

English Abstract

General Situation and Enlightenment of International GLP Regulatory System for Chemicals

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

Received Date: 2020-02-07

Fund Project:

Keywords:

chemicals /
GLP /
regulation

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.

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国际化学品GLP监管体系发展概况与启示

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

General Situation and Enlightenment of International GLP Regulatory System for Chemicals

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国际化学品GLP监管体系发展概况与启示

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 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

English Abstract

General Situation and Enlightenment of International GLP Regulatory System for Chemicals

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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
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