An overview of developmental and reproductive toxicity risk assessment in China.
Development and reproductive toxicology (DART) studies in animals are integral parts of nonclinical safety evaluation of drugs. The State Food and Drug Administration (SFDA) of the People's Republic of China developed a new guideline on DART studies in 2006. This guideline is in broad agreement with ICH guideline S5A (1994), "Detection of Toxicity to Reproduction for Medical Products," and M3, "Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals." However, the new guideline on DART testing differs from ICH in some detailed requirements. This overview reviews some main specifications in China's guidelines on DART testing, and also briefly introduces the recommendations for conducting human clinical trials and marketing authorization in China.
Wang
Haixue
H
Center for Drug Evaluation, State Food and Drug Administration, Jia-1, Fuxing Road, Beijing 100038, China. haixue_wang@yahoo.com
Wang
Qingli
Q
Liao
Mingyang
M
D000014:Abnormalities, Drug-Induced / Q000175:diagnosis*; D000818:Animals; D002681:China; D002986:Clinical Trials as Topic; D000013:Congenital Abnormalities / Q000175:diagnosis / Q000209:etiology; D004195:Disease Models, Animal; D005260:Female; D005333:Fetus / Q000187:drug effects; D006801:Humans; D051381:Rats; D018570:Risk Assessment / Q000379:methods*