什么是 OECD 数据相互认可 (MAD) 系统？

什么是 OECD 数据相互认可 (MAD) 系统？

What is the OECD mutual acceptance of data (MAD) system?

经合组织关于相互接受数据 (MAD) 的决定规定，经合组织成员国根据经合组织测试指南和经合组织良好实验室规范 (GLP) 原则进行化学品测试所产生的数据，可在其他成员国接受，用于保护人类健康和环境的相关目的。该系统还涵盖已申请遵守经合组织良好实验室规范 (GLP) 并加入 MAD 系统的非经合组织国家。这些非经合组织国家可分为两类：完全遵守经合组织 MAD 系统的国家；暂时遵守经合组织 MAD 系统的国家；完全遵守经合组织 MAD 系统的国家将接受经合组织成员国和其他遵守该系统的国家在 MAD 条件下生成的数据。此外，这些国家开发的非临床安全性数据必须得到OECD及其加入国的认可。OECD MAD体系的临时加入国需要接受OECD成员国和其他加入国在MAD条件下生成的数据。然而，在临时加入期间，由临时加入国的GLP监测机构开展的GLP监测活动无需得到OECD MAD决议正式加入国的认可。

The OECD decision on mutual acceptance of data (MAD) provides for data generated by testing of chemicals in an OECD member country in accordance with OECD test guidelines and OECD principles of good laboratory practice (GLP) to be accepted in other member countries for purposes related to the protection of human health and the environment.This system also covers non-OECD countries, which have requested adherence to the OECD GLP and to join the MAD system. These non-OECD countries can be divided into two groups:Countries that are full adherents to the OECD MAD system.Countries that are provisional adherents to the OECD MAD system.Countries that are full adherents to the OECD MAD system will accept data from OECD member countries and other adhering countries generated under MAD conditions. In addition, non-clinical safety data developed in these countries must be accepted by the OECD and adhering countries.Countries that are provisional adherents to the OECD MAD system need to accept data from OECD member countries and other adhering countries generated under MAD conditions. However, during the period of provisional adherence, GLP monitoring activities conducted by the GLP monitoring authority located in the country of the provisional adherence do not have to be accepted by the full members of the OECD MAD decision.