According to the Provisions for Drug Registration, the State Food and Drug Administration (SFDA) developed the Technical Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals with a view to offering guidance to the research and development of pharmaceuticals. The Technical Guideline, which was issued recently, describes the conditions under which carcinogenicity studies are necessary so as to avoid the unnecessary use of laboratory animal, human and material resources. The Technical Guideline is applicable to pharmaceutical products mentioned in the Provisions for Drug Registration, and its basic principles may also be applied to traditional Chinese medicines, natural medicines, and biological products.