国际化学品GLP监管体系发展概况与启示General Situation and Enlightenment of International GLP Regulatory System for Chemicals
葛海虹;赵静;王蕾;刘济宁;韦洪莲;
摘要(Abstract):
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(KeyWords): 化学品;GLP;监管
基金项目(Foundation): 生态环境部化学品污染防治项目(2110304)
作者(Author): 葛海虹;赵静;王蕾;刘济宁;韦洪莲;
Email:
DOI:
参考文献(References):
- [1]United States Environmental Protection Agency(USEPA).Part 160-Good Laboratory Practice Standards[S].Washington DC:Office of Pollution Prevention and Toxics,1989
- [2]United States Environmental Protection Agency(USEPA).Part 792-Good Laboratory Practice Standards[S].Washington DC:Office of Pesticide Programs,1989
- [3]United States Environmental Protection Agency(USEPA).Good Laboratory Practice Standards Inspection Manual[S].Washington DC:Office of Pollution Prevention and Toxics,1993
- [4]United States Environmental Protection Agency(USEPA).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
- [5]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
- [6]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
- [7]Organization for Economic Co-operation and Development(OECD).Council decision on adherence of nonmember countries to the council acts related to mutual acceptance of data[R/OL].(1997-11-26)[2020-02-07].http://www.oecd.org/chemicalsafety/testing/mutualacceptanceofdatamad.htm
- [8]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
- [9]Organization for Economic Co-operation and Development(OECD).OECD Series on Principles of Good Laboratory Practice(GLP) and Compliance Monitoring[S/OL].(1998-01-21)[2020-02-07].http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlabora-torypracticeglpandcompliancemonitoring.htm
- [10]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
- [11]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
- [12]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
- [13]Ministry of Health,Labour and Welfare;Ministry of E-conomy,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
- [14]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
- [15]中华人民共和国生态环境部.关于规范化学品测试机构的公告[EB/OL].(2016-12-18)[2020-02-07].http://www.mee.gov.cn/gkml/hbb/bgg/201701/t20170105_393888.htm
- [16]中华人民共和国生态环境部.关于发布《新化学物质环境管理登记生态毒理测试数据现场核查指南》的公告[EB/OL].(2017-12-12)[2020-02-07].http://www.mee.gov.cn/gkml/hbb/bgg/201712/t20171218_428129.htm