FDA药品批准程序简介课件

,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,*,API,品种推荐,/ANDA,申报和,CGMP,认证支持,/,药品出口贸易渠道整合,Click to edit Master title style,*,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,Click to edit Master title style,*,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,FDA Drug Approval ProcessFDA,药品批准程序,from Chemistry Manufacturing Controls Perspective,化学生产控制,(CMC),展望,上海宝钜,New Drug Development Process,新药的研发过程,1.Research&Development(,研究和开发）,2.Pre-clinical Studies,（,药理毒理研究）,3.Investigational New Drug(IND),Phase I,II,III Clinical Trials,（,临床试验）,4.New Drug Application(NDA),（,新药申请）,5.Post-marketing,（,新药批准后的市场调查跟踪）,Post-approval changes,（,批准后的生产工艺变更）,New Drug Development Process,新药研发程序,New Drug Development Process,新药研发程序,新化学体,有机合成,天然产品,临床前研究,理化特性,生物活性,预制剂,研究型新药,申请,临床试验,I,II,III,阶段,新药申请,FDA,审核,批准前检查,FDA,操作,市场调查跟踪,IV,阶段临床研究,副作用报告,产品缺陷报告,产品线扩展,批准后,CMC,变更,研究：,长期动物毒性研究,产品剂型研发,生产和控制,包装和标签设计,申请人,(,药品研发者,),新药申请,NDA,医学,化学,药学,生物制药学,数据统计,微生物学,CDER,审核,不立档处理,发拒绝信,立档处理该申请吗,否,是,Generic Drug Development Process,非专利药开发过程,1.API Process Development,（,原料药生产工艺开发）,2.Dosage Form Development,（,制剂的研发）,3.Bioequivalent Study,（,生物等效性试验）,4.ANDA Review,（,非专利药的审批）,-DS&DP manufacturing sites CGMP inspection,DS,和,DP,生产现场,CGMP,检查,5.Post-approval Changes,（,批准后的生产工艺变更）,Drug Application,药品申请,NDA(IND),新药,Chemistry,Manufacturing,&Controls(CMC),化学性，生产和控制（,CMC,）,Animal Studies,动物试验,Bioavailability,生物有效性,Clinical Studies,临床试验,ANDA,非专利药,Chemistry,Manufacturing,&Controls(CMC),化学性，生产和控制（,CMC,）,Bioequivalence,生物等,效性,Bioavailability(BA),生物有效性,21 CFR 320.1(a),Defined as“the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action.“,指“从医药产品中吸收到的，且能在作用位置产生有效作用的活性成分或其部分活性成分的比率和范围”,Bioequivalence(BE),生物等效性,21 CFR 320.1(e),Defined as“the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.”,指“活性成分。在经适当设计的研究中，在相似条件下，当 给药的摩尔剂量相同时，在药品的对应作用位置,其被利用的比率和范围没有明显差异”,Generic Drug,非专利药,Definition,非专利药的定义,A generic drug is identical,or bioequivalent to a brand name drug in dosage form,safety,strength,route of administration,quality,performance characteristics and intended use,非专利药在药剂形式、安全性、强度、给药途径、质量、性能特征和使用用途上与专利药相同或者生物等效性相同。,Generic Drug Requirement,非专利药要求,To gain FDA approval,a generic drug must:,要取得,FDA,的批准，非专利药必须：,C,ontain the same active ingredients as the innovator drug(inactive ingredients may vary),包括和新药一样的活性成分（非活性成分可以有所不同）,B,e identical in strength,dosage form,and route of administration,强度、剂型、和给药途径一样,H,ave the same use indications,使用方法一样,B,e bioequivalent,具有生物等效性,M,eet the same batch requirements for identity,strength,purity,and quality,符合同批药品在标识、强度、纯度和质量上的要求,B,e manufactured under the same strict standards of FDAs good,manufacturing practice regulations required for innovator products,生产标准与,FDA,的,GMP,对于新药的严格标准相同,Type of ANDA,非专利药申请的分类,No.,Type of Application,申请类型,Requirement,要求,1,Paragraph I Certification,I,类证书,无专利存在,2,Paragraph II Certification,II,类证书,专利已过期,3,Paragraph III Certification,III,类证书,专利没过期,4,Paragraph IV Certification,IV,类证书,向专利挑战,2002,年全球药品销售分析,国家或地区销售（,US$),销售,%,年增长,北美,203.6,51 12%,欧洲,(EU)90.6 22 8,欧洲其他,11.3 3 9,日本,46.912 1,亚洲,非洲，澳洲,31.6 8 11,(,日本除外）,拉丁美洲,16.54 -10,总数,400 Billion100%+8%,Source:IMS,原料药的年销售额估计约在,US$30-35 Billion(300-350,亿美元,),2003-2004,年全球药品销售分析,国家或地区,销售（,US$),全球市场 年增长,U.S.(,美国,)228.7,46.1%10%,Japan(,日本,)55.411.1 3,Germany(,德国,)27.8 5.6 6,France(,法国,)26.4 5.3 7,U.K.(,英国,)18.4 3.7 11,Italy(,意大利,)17.9 3.6 6,Spain(,西班牙,)12.8 2.6 11,Canada(,加拿大,)10.5 2.1 1,China(,中国,)6.6 1.3 19,Mexico(,墨西哥,)6.3 1.3 11,Top 10(,总数,)410 Billion 82.6%9%,Source:IMS,for the 12 months ending June 2004,原料药的年销售额估计约在,US$40 Billion(400,亿美元,),Worldwide Pharmaceutical Market by Sectors($Billions),世界药品市场分类（单位：十亿美元）,20002001200220032008,增长*,Ethical 317.1363.4401.0437.6677.8 9.1,处方药,Generic 24.0 27.030.537.064.0 11.6,非专利药,OTC 70.573.878.582.0101.0 4.3,Biophar,-22.126.331.036.558.69.0,Maceutical,生物药,Total433.7490.5541.0593.1901.48.7,Source:IMS,*Estimated from 2003 to 2008,Top 10 Therapies10,大类药物,Therapeutic Sale toShare of Annual,ClassesJune 2004Global SaleChange,药物 截至,2004,年 全球销售 年度,分类,6,月的销售额 份额 变化,Cholesterol&triglyceride,胆固醇和,甘油三酸酯,药物,28.1,5.6%13%,Antiulcerants,抗溃疡药,24.9 5.0 5,Antidepressant,抗抑郁药,20.2 4.1 7,Antipsychotics,安定药,13.2 2.6 9,Antirheumatic,nonsteroidals,非类固醇类抗风湿药,13.1 2.6 3,Erythropoietins,红细胞生成素,11.0 2.215,Antiepileptics,抗癫痫药,10.4 2.121,Oral,antidiabetics,口服糖尿病药,9.6 1.912,Cephalosporins,头孢菌素,8.5 1.7 2,Top 10 Therapy 150.3 Billion30.2%10%,10,大药物,1503,亿美元,Source:IMS,for the 12 months ending June 2004,来源：,IMS,，以,2004,年六月截至第,12,个月计,Top 10 Products(2003-2004)10,大药品（,2003,2004,）,Brand Name MarketerSales Annual,(Generic Name)($Billion)Change,品名（非专利药名）生产商 销售额（十亿美元）年度变化,Liptor