ECHA 接受哪些研究作为 GLP 研究？

ECHA 接受哪些研究作为 GLP 研究？

What studies does ECHA accept as GLP studies?

一般而言，ECHA 接受来自以下测试设施的数据作为 GLP 数据：来自 OECD 成员国或 OECD 数据相互接受 (MAD) 系统的完全遵守者；以及来自 OECD MAD 系统的临时遵守者，并且其实验室已经由有关 GLP 监督机构和 OECD GLP 监督机构联合检查过。在未加入 OECD MAD 系统的国家/地区的测试设施中进行的研究可在以下条件下被 ECHA 接受为符合 GLP 的研究：在进行研究之前，测试设施的 GLP 合规性已通过以下机构的检查：欧盟 GLP 监督机构（包括通过 EEA 协议的挪威）；或与欧盟签订相互承认协议的以色列、日本和瑞士的 GLP 监督机构；或根据具体情况检查 OECD 成员国或 OECD MAD 系统的完全遵守者的其他 GLP 监督机构；或其他国家GLP监测机构，该机构已由欧盟GLP工作组代表进行现场评估，且其合规监测计划可视为等同于欧盟GLP合规监测计划；并且已发现测试设施的运行符合GLP原则。另见问答119。

In general, ECHA accepts data as GLP data where this data comes from a test facility:from countries that are OECD member states or full adherents to the OECD mutual acceptance of data (MAD) system; andfrom countries that are provisional adherents to the OECD MAD system and in which laboratories have been inspected jointly by the GLP monitoring authority concerned and by an OECD GLP monitoring authority.Studies that are conducted in a test facility situated in a country which has not joined the OECD MAD system can be accepted by ECHA as GLP compliant studies under the following conditions:Before performing the study, the GLP compliance of the test facility has been inspected by: an EU GLP monitoring authority (including Norway through EEA agreement); or GLP monitoring authorities in Israel, Japan and Switzerland with whom the EU holds mutual recognition agreements; or other GLP monitoring authorities of OECD member states or full adherents to the OECD MAD system on a case-by-case basis; orother national GLP monitoring authority which has been assessed on-site by representatives of the EU GLP Working Group and whose Compliance Monitoring Programme could be regarded as being equivalent to the EU GLP Compliance Monitoring Programme; and The test facility has been found to be operating in compliance with GLP principles.See also Q&A 119.