Abstract:

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 1990s. 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.

Key words: GLP, National Key Technology R&D Program, China