Good laboratory practice（GLP） plays an important role in pre-clinical studies, which are a key stage in new drug research and development（R＆D）. The development of GLP in China started in the late 1990 s. Following 20 years of developments, GLP system has already been established in this country. This review firstly evaluated all the institutions in this field, and described the annual number and total number of institutions, the distribution of GLP institutions, the types of GLP institutions, and the service provided by these GLP institutions. Since the initiation of the National Key Technology R＆D Program during the 11 th Five-Year Plan, it had a significant effect on the development of GLP. Therefore, the institutions which have undertaken projects from this program will be introduced later. We also described the infrastructure of hardware and software in GLP institutions along with their faults, such as variation in development and the lack of innovation.
人用药品注册技术要求国际协调会(International Conference for Harmonization,ICH)于2017年12月颁布了Q12新草案,该草案补充了药品生命周期的管理内容,对药品的安全性评价和风险评估具有重要的指导意义。本文概述了ICH Q12的最新内容和Q12对安全性评价和风险评估的最新要求,总结了安全性评价在药品生命周期管理中的作用及应用现状,以期为保障药品的安全性,促进药品生命周期管理方式发展以及公众合理用药提供参考。
