主要负责药品、生物制品、化妆品的功效（或效价）和安全性评价等监督、注册和委托检验工作；认证认可项目近百项。拥有高级职称人员6人、博士4人、硕士4人，在毒理评价、体外生物活性测定及新方法研究等方面经验丰富。配有基质辅助激光解析电离飞行时间质谱、数字式单分子免疫阵列分析平台、核酸分析系统、自动化高通量胚胎细胞分选系统、小动物高分辨率超声成像系统、灌流式细胞代谢检测仪、全自动膜片钳系统、液质联用仪、高通量测序仪、透射电镜等实验仪器，可开展新药筛选、药效学及急性毒性、长期毒性、遗传毒性、免疫原性、生殖毒性、安全药理、药代动力学等安全性评价等研究工作，并且制作功效评价用各种疾病模型，建设有“化妆品动物替代试验技术重点实验室”和“遗传毒性检测与方法研究重点实验室”。

　　We are mainly engaged in supervision, registration, entrustment inspection of efficacy assessment and safety evaluation studies on drug, biological product and cosmetics. We have the ability to carry out about hundred of testing items passed CMA and CNAS certification. In our department, 6 staffers have obtained senior professional title, 4 with PhD degree and 4 with master degree, all with rich practical experience in toxicological evaluation, bioassay and new method research. We are equipped with many advanced instruments including Matrix Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry (MALDI-TOF-MS), Single Molecular Array Analysis Platform , Nucleic Acid Analysis System (MassARRAY? System), Large Particle Analysis & Sorting System, High Resolution Ultrasound Imaging System for Small Animals, Cellasys Delivers System with Metabolism Monitor, Patchliner Automatic Patch-clamp System, Liquid Chromatograph/Mass Spectrometer (LC/MS) , High-throughput Sequencer, Transmission Electron Microscope (TEM), etc. We can carry out new drug screening, pharmacodynamics and safety evaluation research on acute toxicity, chronic toxicity, genetic toxicity, immunogenicity, reproduction toxicity, safety pharmacology, pharmacokinetics, etc., as well as simulate a variety of disease animal models used in the efficacy assessment. We construct the key laboratory of study on animal alternative testing techniques in safety evaluation of cosmetics and the key laboratory of genetoxicity detection and method study.

　　部门座右铭        以创新为动力，以质量求发展。