Establishment of a GLP compliance program for drug safety studies at SIMM

Abstract

AbstractThe document ‘Good Laboratory Practice Regulations for Nonclinical Drug Safety Studies’ issued in China on 14 October 1999 was updated by China's State Food and Drug Administration (SFDA) and became effective as of 1 September 2003. In October 2003, SFDA started to commission Good Laboratory Practice (GLP) inspections. Since then, China has adopted a national GLP conformity accreditation system, and it became increasingly required that drug safety studies in China were to be carried out in accordance with the principles of GLP regulations. Development of a standardized safety study platform also plays an important role in the strategy ‘Establishing National Drug Innovation System in Knowledge Innovation’, led by Shanghai Institute of Materia Medica (SIMM), China Academy of Sciences. Demands from outside and inside SIMM required that a GLP compliance program for drug safety studies be established at SIMM. However, the establishment of a GLP compliance program was challenging. In this article, the strategies adopted and the progress made towards meeting the challenges of establishing a GLP compliance program for drug safety studies at SIMM are described. Copyright © 2005 John Wiley & Sons, Ltd.