比较了国内指导原则《药物重复给药毒性试验技术指导原则》和《药物毒代动力学研究技术指导原则》与ICH S4和ICH S3A的对应关系及差异，并对ICH S4及ICH S3A在我国实施的可行性及存在的技术困难和法规障碍进行了讨论，最后根据CDE和ICH指导原则的差异对比情况对我国实施ICH S4及ICH S3A给出了建议，以期为国内重复给药毒性试验及药物毒代动力学研究提供借鉴。

The correspondence and differences of "Technical guidelines for repeated drug administration toxicity testing" and "Technical guidelines for pharmacokinetic research" and ICH S4 and ICH S3A guidances are compared in this paper. Meanwhile the technical difficulties of ICH S4 and ICH S3A in the feasibility of implementation in domestic and the obstacles involved laws and regulations were discussed. Then according to the guidelines comparison between the CDE and ICH, suggestions were expected to supply reference for the local repeated dose study and toxicokinetics.