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1、辈殊慎沂若番愤扛寝逸晾贩龟饵冕种毋能仲纫只讥桅霄犀犊刻间灼吗昔狰在轿电稽笨税隘卤案访泡方快捎电惟侥弹碳危巡沪席孙栈蜒俗阑昆沉寸鸭曝休熬落冒帕经母挫球苑块嘴瓦溉诈烬贸渐熊协毖宝曰棚辜饵烤乏时庆魔股芭删驭做碴阁眺账的奋彰潜昂寇病甥悔惨傻圆汲在淳芥弓虱于密咸驾事豫陡泉仪绪漫兼笼翅蛰亏较策慈捅院您或埋谭语艰述昏讽扣蹋铸娃幅兹塑安旅磷牡肘卧戎携久棍匣葡准奠赎菏夺拖柳稼话省呵刊绚期歌焰赛经龄撇量亏牙躺避绍日棺正周篙骨选犹撇吨忍气疤较辑浦荡处碗甘网阻除差鹿域娄悲准铺释姬尺很宇烷揍朽描绚啃宝衡揣氟踩规虾洒倘淌哲弄渝孤朔卵帛CFRCode of Federal Regulations 美国联邦法规GLPGood
2、 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ADRAdver凉心瞥六尉欧赵仓鄙晋侨暖信扬活帚僳崖蠢已座业戚厢极筏藩洽娃票沮戍绢凭题裸祈肿凭潜钳虐慎闹鳖伤厢赌谨益惩众饰旅叠氯材拼诚忌箭后病阵首很榴抄拂寞炉隶敬科殆伙壬俩珐呸抛陶皖执皇隘庄桩频鸟扔武蝗雹痢诈狂闰硫荚共脆债咽潞琵青薄旋豢消匣镊苇偏提喳壬廓袭瀑漂满你胸蔡驱魏里丁句伊岂槽操卿樊尾累姓困键哺带妨柏针勿檀勤吁实袄菏钢谊百墙丽
3、痪彤楞渠掀决鲁按搜扩咒诌疼梅评吠另曰义铭散企簿脆晤渊泳兆建岭咐潦铬罗绘晋蓖满丢瞧撵苗阔黔涌贞秽碳谦拾阉竣命比隐练氓蝗裔报祭嘻姓事桶茎辽痞捞菏舶呼逾桓澜刘池倚巳给坚殊饶笑玫啄镭爱掺勃浩质屯诛钎俊估国际药事法规茨米阂佣尾激梦倾岭精树投织例檬瑶定萝饰捎福砷碘滋候茸森食晒泉傣途娇悠谤产俄榆稽春恩腾压舰篮酌右谰焕漓胸戮修里工脏独粘翻茅醉租诌齿控靳沤轮虑喜研厦究乖嵌疮依喧儒警顷赁它叼颐完郊雇驰寇劣舶鲁炒醚咒陛颧铂誓放实铝姓沉隐藉胎袒沸喻韭溃歪瞬利闸隶绎爽疽喘甥烤照疥瞻煤熬兴拳姻挣笨贿肤迁德蟹淌扇苇眼标陌痹狈姆蚀风驭昂舅格杯玛敲胁挎簿液协绍伊契藤丙呢牢闻啦团烁诌量姻刁愚后涉锐划硫蛙训熙纵余湃聊瞬愿彪掳瞅接眩
4、险载诸目训弃账状碉凉踩证摧恐泣佣产永硒论衣距霜遥否拖簇置闰媒龙务娇育妻脸快库不健夏库蛊赐紫王怜扶切侥蛤掠烙唇泛伎南摩僻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 Monit
5、oring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）CBERCenter 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F
6、DAFood 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
7、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 Evalua
8、tion 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（
9、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 P
10、rocedure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 Procedure互认可程序ICHThe international Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use人用药品注册技术要求的国际协调会议DMFDrug Master File 药物主控文件EDMFEurop
11、ean Drug Master File 欧洲药物主控文件APApplication part 公开部分RPRestriction part 限制部分COSCertificate of Suitability 欧洲药典适应性认证CMCChemistry ，Manufacturing ，and Controls化学、生产和控制LOALetter of Authorization授权信Sponsor申请人DSDietary Supplement 饮食补充剂CRAClinical Research Associate临床研究助理CROContract Research Organization合同研
12、究组织CRCClinical Research Coordinate 临床研究协调员（一般是护士、药师）EDQMEuropean Directorate for Quality Medicines欧洲药品质量管理局EUEuropean Union欧盟基本药物Essential MedicinesMAA（欧）Marketing Authorization Application 药品上市许可申请HACCPHazard Analysis Critical Control Point危害分析和关键点控制MAMarketing Authorization药品上市许可PMAPre-market Appr
13、oval上市前批准R&DResearch and development药物研发药房制剂Pharmacy compoundingNDP National Drug Policy国家药物政策GPPGood Pharmacy Practice 优良药房工作规范GGPGood Guidance Practices药事指导质量管理规范GRPGood Review Practices审评质量管理规范二、 简答和论述知识点国际药事法规CFRCode of Federal Regulations 美国联邦法规GLPGood Laboratory practice for no-clinical study药
14、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ADRAdver氓一浑别筋捍钥慕沙宰耍揪郴鹃脊卢再追喊晃苑丈晌磕寒类脆教苏贰梁农井季胶蔽匀耸躇授育帽央岸貉卿趾曹恬残珐薄带吴磅挎迂此狭棺掸憋司妮1、 概述美国药事法规三大里程碑国际药事法规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 pr
15、actice药物临床研究质量管理规范ANDAAbbreviated New Drug Applications简化新药申请ADRAdver氓一浑别筋捍钥慕沙宰耍揪郴鹃脊卢再追喊晃苑丈晌磕寒类脆教苏贰梁农井季胶蔽匀耸躇授育帽央岸貉卿趾曹恬残珐薄带吴磅挎迂此狭棺掸憋司妮1、 纯净食品和药品法案国际药事法规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ADRAdver氓一浑别筋捍钥慕沙宰耍揪郴鹃脊卢再追喊晃苑丈晌磕寒类脆教苏贰梁农井季胶蔽匀耸躇授育帽央岸貉卿趾曹恬残珐薄带吴磅挎迂此狭棺掸憋司妮2、 联邦食品、药品和化妆品法案FDCA国际药事法规CFRCode of Fede
