Turnheim Dian
Environment, Health and Safety Division, Environment Directorate, OECD, 2 rue André Pascal, 75775 Paris Cedex 16, France.
Ann Ist Super Sanita. 2008;44(4):327-30.
This paper describes the current situation as regards implementation of the Organisation for Economic Co-operation and Development (OECD) Council Decisions related to the mutual acceptance of data (MAD) in the assessment of chemicals in the 30 OECD member countries as well as in several non-member countries which adhere to the Council Acts. The cornerstone of MAD is the knowledge of and ensuing confidence in national good laboratory practice (GLP) compliance monitoring programmes which guarantees the acceptability for regulatory purposes of non-clinical environment and health safety data on chemicals and chemical products tested in these countries. The pilot project of mutual joint visits (MJV) undertaken by the OECD working group on GLP between 1998 and 2002 to observe and understand the way compliance monitoring is carried out in member countries was the successful basis for evaluation of the readiness of non-members to become full members of the OECD system on MAD and for a continuing on-site evaluation programme which began in 2008. The MJV project, its results and follow up by the Chemicals Committee and the continuing programme on on-site evaluations are described. Details are given on the work with non-member economies in the area of MAD and the status of their GLP compliance monitoring programmes.
本文描述了经济合作与发展组织(OECD)理事会关于化学品评估中数据互认(MAD)的决定在30个OECD成员国以及若干遵守理事会法案的非成员国中的实施现状。数据互认的基石是对各国良好实验室规范(GLP)合规监测计划的了解以及由此产生的信心,这确保了在这些国家测试的化学品和化学产品的非临床环境与健康安全数据在监管目的上的可接受性。1998年至2002年期间,OECD GLP工作组开展的相互联合访问(MJV)试点项目,旨在观察和了解成员国开展合规监测的方式,该项目是评估非成员国是否准备好成为OECD数据互认体系正式成员以及2008年开始的持续现场评估计划的成功基础。本文描述了相互联合访问项目、其结果以及化学品委员会随后的跟进情况,还有持续的现场评估计划。详细介绍了在数据互认领域与非成员国经济体开展的工作及其GLP合规监测计划的状况。