《国际药事法规》《国际事法规》.doc

CFRCode of Federal Regulations 美国联邦法规GLPGood Laboratory practice for no-clinical study 药物非临床研究质量管理GCPGood Clinical practice药物临床研究质量管理规范ANDAAbbreviated New Drug Applications简化新药申请ADRAdverse Drug Reaction 药品不良反应ADRMAdverse Drugs Reactions Monitoring药品不良反应监测AEAdverse effect 副作用APIActive pharmaceutical Ingredient原料药OTCOver-the-counter非处方药CDERCenter for Drug Evaluation And Research药物评价和研究中心（美国）CBER Center for Biologics Evaluation and Research生物制品评价研究中心 FDCAFederal Food，Drug，and Cosmetic Act 《联邦食品、药品和化妆品法案》（美）Pure food and Drug Act,1906《纯净食品与药品法案》FDAFood and Drug Administration 食品药品监督管理局（美国）HHSHuman and Health Service美国人类健康服务部CTPCenter for Tobacco Products烟草产品中心INDInvestigational New Drug临床研究申请NDANew Drug Application新药申请CFSANThe Center for Food Safety and Applied Nutrition 食品安全和应用营养中心DEADrug Enforcement Administration 美国特殊药品监督管理局NABPNational Association of Boards of Pharmacy美国全国药房理事会协会SBPState Board of Pharmacy州药房理事会FTCThe federal trade commission 联邦贸易委员会MHLW（日）The ministry of Health ,labor,and welfare厚生劳动省PMDA（日）Pharmaceutical and Medical Devices Agency药品与医疗器械代理处EMA （欧）European Medicines Agency欧盟药品局EMEA（欧）European Agency for the Evaluation of Medicinal Products (为EMA前身)CHMP（欧）Committee for Medicinal Products for Human use人用药品委员会CVMP（欧）Committee for Medicinal Products for Veterinary use兽用药品委员会COMP（欧）Committee for Orphan Medicinal Products罕见病药品委员会HMPC（欧）Committee for Herbal Medicinal Products草药委员会PDCO??欧）Pediatric Committee 儿科委员会CAT（欧）Committee for Advanced Therapies前沿疗法委员会CHM（英）Commission on human medicines人用药品委员会 MHRA（英）Medicines and Healthcare products Regulatory Agency 药品和健康产品管理局CTDCommon Technical Document通用技术文件FDAAAFood and Drug Administration Amendments Act of 2007食品药品监管修正案IRBInstitutional Review Board伦理委员会CPCentralized Procedure集中审批程序INP（NP）Independent National Procedure成员国审批程序DCP Decentralized Procedure分权程序MRPMutual Recognized Pro