FDA仿制药费用(GDUFA)支付(中英文)
美国仿制药用户付费制度8月18日会议纪要
FDA-Industry Generic Drug User Fee (GDUF) Negotiations MeetingAugust 18, 2011, 9:00-3:00pmFDA White Oak CampusSilver Spring, MD_______________________________________________________________________ PurposeTo finalize changes to a draft letter of performance commitments and goals, discuss operationalizing fee structures for the generic drug user fee act (GDUFA) program, and discuss legislative language.ParticipantsGeneric Pharmaceutical Association (GPhA)Debbie Jaskot (phone) Teva North AmericaPharmaceuticalsWatsonCharlieMayr(phone)Marci McClintic-Coates (phone) Mylan LabsTom Moutvic (phone) Sagent PharmaceuticalsRamsburg MylanLabsLaraStec PerrigoRichEuropean Fine Chemicals Group (EFCG)Carla Vozone (phone) HovioneBulk Pharmaceutical Task Force (BPTF) of the Society of Chemical Manufacturers and Affiliates (SOCMA)Company,Inc.ChemicalCopperheadAlanNichollsLaboratoriesPolypeptideBrant(phone)ZellFDALeslie Ball Center for Drug Evaluation and Research (CDER) Peter Beckerman Office of the Commissioner (OC)Commissionerof(OC)OfficeLisaBerryHilmar Hamann Center for Drug Evaluation and Research (CDER) Brian Hasselbalch Center for Drug Evaluation and Research (CDER)forDrugEvaluation and Research (CDER) CenterJonesMikeDrugforEvaluation and Research (CDER) KevinLaserCenterMari Long Office of the Commissioner (OC)Marie Angeline O’Shea Center for Drug Evaluation and Research (CDER) Suzanne Pattee Center for Drug Evaluation and Research (CDER)of Regulatory Affairs (ORA)Riggio OfficeLynnetteEdward Sherwood Center for Drug Evaluation and Research (CDER)Adam Southers Center for Drug Evaluation and Research (CDER) Keith Webber Center for Drug Evaluation and Research (CDER) Russell Wesdyk Center for Drug Evaluation and Research (CDER)DiscussionThe groups met on August 18, 2011 to make final changes to the goals letter on performance commitments, to discuss the draft legislative language for the statutory proposal that will accompany the goals letter for generic drug user fees act (GDUFA) program, and to learn more about FDA user fee payment mechanisms through iStore and iReceivables. The groups discussed recent press coverage of the negotiations and the need to finalize the goals letter and legislative language.In reviewing the final draft of the goals letter, the parties discussed overview language explaining that fees under GDUFA are expected to be reasonably low because of the industry’s mission to provide consumers access to lower cost drugs. The parties discussed mechanisms to explain to the public and industry that fees are expected to be orders of magnitude lower than application fees under the PDUFA program. GPhA discussed the interaction between complete response letters and citizen petitions, particularly with regard to citizen petitions submitted prior to legislation in 2007 establishing response timelines under Section 505(q) of the Federal Food, Drug and Cosmetic Act (FDCA); this was noted to be a small number of petitions existing at the agency. FDA indicated that it will strive to address issues raised in citizen petitions in complete response letters where possible.In response to industry’s request for more information on payment mechanisms, the agency presented its procedures for user fee electronic payment systems to industry. iStore enables the user fee payor to create an invoice with a cover sheet, add specific identifying information, such as abbreviated new drug application (ANDA) or drug master file (DMF) number, payment ID number, confirmation number and a cover sheet number. Using this information, the payor will then pay the fees via bank checks, Fedwire, or to the US Treasury. Payors can use iReceivables to obtain information similar to a receipt, which has information on transactions, account balances including any overdue payments.The FDA shared with industry draft legislative language necessary for Congress to implement the program for generic drugs. The draft legislative language, once enacted, will provide authority for FDA to collect a fee, definitions of the types of applications and facilities that will be subject to fees, and mechanisms by which FDA will notify industry of fee amounts, among other things. Some elements, such as an inflation adjuster, from the prescription drug user fee act (PDUFA) are included and the overall statutory structure is similar to PDUFA.FDA explained its concerns regarding industry’s suggestion the prior week of a possible “trigger” or “overflow mechanism” in which fees from a stable funding source (e.g., facilities) would be paid through an additional “spillover” fee source that is variable (e.g.,submissions) and explained that the agency could only consider such a mechanism if the fees “spilled over” into equally stable, non-variable funding sources. FDA also voiced concern that such a mechanism could increase the cost of administering the program. In light of these considerations, and the late date at which this proposal arose, the parties agreed not to incorporate a “spillover” fee. The parties reiterated their agreement regarding previously discussed fee distributions, with API manufacturers providing 20 percent of overall program funds, and finished dosage form manufacturers providing 80 percent. They also reaffirmed that 30 percent of fees will come from ANDA and DMF fees, with 70 percent of fees coming from facility fees. In order to provide more certainty about the typical types of fees to be collected from facilities, the groups urged FDA to take whatever steps are possible prior to the program’s implementation to identify the number of facilities subject to fees.The groups also discussed the relative break out of fees that will be included in the GDUFA statute. The statute will not include specific fee amounts, as that must be calculated annually, based on then current available information. This mirrors the fee setting process for other user fees. It was stressed that the size of the fees will not be comparable to PDUFA application fees. Rather, the industry found that the potential fees that were discussed were reasonable for both large and small manufacturers, and well worth the investment given the certainty of timing that will arise from the performance goals from FDA. In identifying which facilities would be subject to DMF fees, the group talked about ways the FDA and industry associations can work to communicate about the program prior to and during its implementation.The groups will continue to work through the draft of legislative language, will finalize the goals letter on performance commitments in continuing discussions before the next face-to-face meeting on August 31, 2011. The parties are working toward a Sept. 9th deadline to provide the final goals letter and legislative language for internal administration review. All groups indicated a willingness to conduct additional discussions by telephone before the deadline.Next MeetingThe next meeting will be held at FDA on Wednesday, August 31st where FDA and industry hope to finalize the performance goals letter and the draft legislation regarding fee structure to operationalize the program.。
2013财年FDA仿制药用户积压费用通知(中英文)
DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration[Docket No. FDA–2012–N–0007]Generic Drug User Fee—Backlog Fee Rate for Fiscal Year 2013仿制药用户费用---积压费2013财年费率The Food and Drug Administration (FDA) is announcing the rate for the backlog fee related to generic drug user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), authorizes FDA to assess and collect user fees for certain applications and supplements associated with human generic drug products, on applications in the backlog as of October 1, 2012, on finished dosage form (FDF) and active pharmaceutical ingredient (API) facilities, and on type II API drug master files (DMFs) to be made available for reference. GDUFA directs FDA to establish each year the Generic Drug User Fee rates for the upcoming year. In the first year of GDUFA (FY 2013), some rates will be published in separate Federal Register notices because of the timing specified in the statute. Each year thereafter the GDUFA fee rates will be published 60 days before the start of the FY. This document establishes the FY 2013 rate for the backlog fee ($17,434). This fee is effective on October 1, 2012.FDA公布2013财年人用仿制药简略新药申请（ANDA）预批准变更（PAS）和药物主文件（DMF）费用。
美国FDA医疗器械费用
美国FDA医疗器械费用2018/9/61Presentation Overview•FDA 2019财年费用•药品企业的收费•医疗器械企业官方费用•Summary / Questions & Answers2FDA 公布2019财年医疗器械和仿制药官方费用32019年费用美国食品药品监督管理局（FDA）近期公布了2019财年（FY）仿制药企业付费法案（GDUFA）和医疗器械付费法案（MDUFA）的收费计划。
2019财年的这两项费用将在2018年10月1日开始生效。
4药品企业的收费5概述GDUFA的收费是针对特定类型的药品企业。
从2018年10月1日起，仿制药品企业将需要向FDA支付所有适用的企业费用。
除此之外，GDUFA还要求新递交二类（Type II）药物管理档案（DMF）和简略新药申请（ANDA）的企业向FDA支付费用。
详情请参见下文的费用表。
62019财年GDUFA 官方费用7费用类型2018财年2019财年场地费用美国非美国美国非美国原料药（API ）$45,367$60,367$44,226$59,226药物制剂（FDF ）$211,087$226,087$211,305$226,305合约生产机构（CMO ）$70,362$85,362$70,435$85,435ANDA 项目费用-取决于当年度持有的已批准量大型企业（持有20个及以上ANDAs ）$1,590,792$1,862,167中等企业（持有6-19个ANDAs ）$636,317$744,867小型企业（持有5个及以下ANDAs ）$159,079$186,217申请费用ANDA $171,823$178,799Type II DMF$47,829$55,0132019财年GDUFA的重大变化✓ ANDA项目费用——在2018财年，FDA公布了简略新药申请持有者企业的项目费用。
这些企业缴纳的费用取决于其在当年10月1日持有的简略新药申请批准量。
美国仿制药用户付费制度FDA确认信
FDA-Industry Generic Drug User Fee (GDUF)Announcement of Ratification; Next StepsSeptember 9, 2011_______________________________________________________________________ Announcement of RatificationThe Food and Drug Administration is pleased to announce the ratification by FDA and each of the three industry trade associations participating in the generic drug user fee negotiations of a goals letter and proposed legislative language. These documents have been carefully negotiated between FDA, the Generic Pharmaceutical Association, the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturers and Affiliates, and the European Fine Chemicals Group, in a series of negotiation sessions over the last six months.As is the case in the reauthorization process for FDA’s other, already existing, user fee programs, the negotiated documents are not being publicly released at this time, as they now need to undergo review by the Department of Health and Human Services and the White House prior to their public release and their eventual presentation to Congress. However, general outlines of the negotiated program are available from the meeting minutes that have been regularly posted during the negotiations.Minutes of negotiation sessions can be found at the following webpage:/ForIndustry/UserFees/GenericDrugUserFees/ucm256662.htm Additional information on the need for and process of negotiating a generic drug user fee program, and materials from FDA’s public meetings and stakeholder updates on the process can be found at the following webpage:/ForIndustry/UserFees/GenericDrugUserFees/default.htmNext StepsThe goals letter and proposed legislative language will now be provided to the Department of Health and Human Services for review, and will thereafter be provided to the Office of Management and Budget for review. The agency will post the final cleared goals letter and proposed legislative language for the generic drug user fee program upon receiving clearance from OMB, as the agency does in its other user fee negotiations. FDA anticipates providing a generic drug user fee package to congress in January, accompanying the reauthorization packages for FDA’s other user fees.。
FDA仿制药一致性评价指导指南(中英文版)
Guidance for Industry Controlled Correspondence Related to Generic DrugDevelopment行业指南：有关仿制药研发的书面咨询This guidance represents the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.该指南代表了FDA对该主题目前的看法。
它并不会赋予任何人任何权利，也不会约束FDA或公众，如果有替代的方法能够满足法律法规的要求，可以使用替代的方法。
如果想探讨替代的方法，请联系该指南首页中FDA 负责执行该指南的工作人员。
I.INTRODUCTION 简介This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit correspondence to FDA requesting information related to generic drug development. This guidance also describes the Agency’s process for providing communications related to such correspondence. FDA is issuing this guidance as part of its implementation of the Generic Drug User Fee Amendments of 2012 (Public Law 112-144, Title III), commonly referred to as GDUFA.该指南描述了仿制药生产商以及相关行业向FDA提交书面咨询，询问有关仿制药研发信息的过程，同时还描述了FDA针对这些书面咨询提供交流的过程。
美国FDA CGMP英汉对照版
美国FDA CGMP英汉对照版Subpart A-General Provisions§211.1 Scopea)The regulations in this part contain theminimum current good manufacturing practice for preparation of drug products for administration to humans or animals.b)The current good manufacturing practiceregulations in this chapter, as they pertain to drug products, and in parts 600 through 680 of this chapter, as they pertain to biological products for human use, shall be considered to supplement, not supersede, the regulations in this part unless the regulations explicitly provide otherwise. In the event it is impossible to comply with applicable regulations both in this part and in other parts of this chapter or in parts 600 through 680 of this chapter, the regulation specifically applicable to the drug product in question shall supersede the regulation in this part.c)Pending consideration of a proposedexemption, published in the Federal Register of September 29, 1978, the requirements in this part shall not be enforced for OTC drug products if the products and all their ingredients are ordinarily marketed and consumed as human foods, and which products may also fall within the legal definition of drugs by virtue of their intended use. Therefore, until further notice, regulations under part 110 of this chapter, and where applicable, parts 113 to 129 of this chapter, shall be applied in determining whether these OTC drug products that are also foods are manufactured, processed, packed, or held under current good manufacturing practice.§211.3 Definitions.The definitions set forth in §210.3 of this chapter apply in this part.A．总则211．1 范围（a）本部分的条例包含人用或兽用药品制备的现行最低限度的药品生产管理规范（GMP）。
FDA有关术语中英对照
FDA（FOOD AND DRUG ADMINISTRATION）：（美国）食品药品管理局IND（INVESTIGATIONAL NEW DRUG）：临床研究申请（指申报阶段,相对于NDA 而言）；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究结束）NDA（NEW DRUG APPLICATION）：新药申请ANDA（ABBREVIATED NEW DRUG APPLICATION）：简化新药申请EP诉（EXPORT APPLICATION）：出口药申请（申请出口不被批准在美国销售的药品）TREATMENT IND：研究中的新药用于治疗ABBREVIATED（NEW）DRUG：简化申请的新药DMF（DRUG MASTER FILE）：药物主文件（持有者为谨慎起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。
只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA在审查IND、NDA、ANDA时才能参考其内容）HOLDER：DMF持有者CFR（CODE OF FEDERAL REGULATION）：（美国）联邦法规PANEL：专家小组BATCH PRODUCTION：批量生产；分批生产BATCH PRODUCTION RECORDS：生产批号记录POST-OR PRE- MARKET SURVEILLANCE：销售前或销售后监督INFORMED CONSENT：知情同意（患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验）PRESCRIPTION DRUG：处方药OTC DRUG（OVER—THE—COUNTER DRUG）：非处方药FDA（FOOD AND DRUG ADMINISTRATION）：（美国）食品药品管理局IND（INVESTIGATIONAL NEW DRUG）：临床研究申请（指申报阶段,相对于NDA 而言）；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究结束）NDA（NEW DRUG APPLICATION）：新药申请ANDA（ABBREVIATED NEW DRUG APPLICATION）：简化新药申请EP诉（EXPORT APPLICATION）：出口药申请（申请出口不被批准在美国销售的药品）TREATMENT IND：研究中的新药用于治疗ABBREVIATED（NEW）DRUG：简化申请的新药DMF（DRUG MASTER FILE）：药物主文件（持有者为谨慎起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。
GDUFA费用厚此薄彼_王迪
医药经济报/2013年/2月/18日/第006版原料药GDUFA费用厚此薄彼王迪今后，外国仿制药和原料药生产厂家出口到美国的产品，将不得不比它们的美国同行要多付出15000美元，这是因为美国食品药品管理局（FDA）在对海外工厂的检查上，需要支出额外的费用。
根据美国联邦公报上的一份通知，1月16日，FDA首次公布了所有仿制药和原料药生产厂将要支付的费用额度，这无疑对在美国市场上销售产品的厂家增加了附加条件。
在758家自行登记的生产固定剂量配方产品（FDF）的厂家中，325家美国工厂每家将支付175389美元，而433家外国工厂每家将支付190389美元。
在885家自我认定的原料药工厂中，122家美国工厂每家将支付26458美元，而每家外国工厂则支付41458美元。
费用的支付将在3月4日到期。
美国化学品制造商及附属公司协会（SOCMA）原料药工作小组执行主任John DiLoreto表示，这份公告还没有让人真正感到吃惊的条款。
但他补充说，FDA检查计划的一个主要缺点，就在于它对外国工厂实施鉴定和检查能力的不足，未来5年里，FDA的目标就是要让所有外国工厂与美国工厂一样接受同样频次的检查。
这些费用的支付是由美国通过的《仿制药申报者付费法案》（GDUFA）强制予以规定的，没有进行自我认定的仿制药和原料药生产厂家将不允许在美国市场上销售其产品。
根据FDA的要求，在药厂还没有支付费用之前，FDA将不会接受该工厂提交的新仿制药申请。
如果在到期日之后的20天内还没有缴足费用，这家工厂将会被公布在一份对外公开的欠款名单上。
DiLoretto补充说，最初商讨时，GDUFA行业谈判代表同意，原料药生产商将支付总费用的20%，FDF生产商将支付余下的80%。
行业代表之间达成的这一协定，是因为他们认识到，原料药生产厂家的利润空间较为微薄，并且在成本差异上所占的比例不同。
虽然总共有1643家工厂进行了自我认定，但离FDA此前估计的，大约有2000家工厂将会进行自我认定还有一定距离。
FDA常用词汇中英文，请收好！
FDA常用词汇中英文，请收好！AAccelerated: 加速条件 Accuracy: 准确性AIP（Application Integrity Policy）: 申请完全政策制裁ANDA（Abbreviation New Drug Application）:仿制药或仿制新药申请API（Active Pharmaceutical Ingredient）:原料药或活性药。
原简称BPC（Bulk Pharmaceutical Chemical）,现常用API。
在药典和一些论文中也常用Drug Substance 或Substance 来代表原料药。
Appearance: 外观Assay:含量Assessment: 药厂自我评估（厂家组织进行的对药厂本身设施有关文件的模拟FDA检查）Audit:审查（预审查，多用于美方原料药用户，在FDA和PAI之前到药厂进行现场预检查）Auditor:审核员Audit trail: 审计踪迹BBasket:篮子式Batch production records: 批生产纪录Batch records:批号（量）纪录（即batch production and control records 批量生产和检验纪录）BPC:（Bulk Pharmaceutical chemical）原料药Bracketing stability design:稳定性试验的括号分组设计Blend uniformity: 均匀度CCalibration: 校正或校准（对设备，仪器和衡器等的准确度进行校正）Certification of Areas for GMP compliance: (检验企业实施现行药品生产管路规范部门的标准操作规程)CFR 21 Part 11（Code of federal Registry Part11）：联邦法规法典标题21第11部分CGMP（Current Good Manufacturing Practice）：现行药品生产质量管理规范Change control form：也简称CCF 变更控制表Change control：变更控制Cleaning validation：清洁验证CMC（Chemistry and manufacture control）化学和生产的控制Compliance：符合性Compatibility：共存性或兼容性Content uniformity test: 产品含量均匀性测定Container closure system: 容器封闭系统 COA（Certification of analysis ）：分析合格证书，检验报告或检验报告单DDelayed release：延期放行Design qualification: 设计确认Dissolution test：溶出度测试 Deviation records：偏差纪录DMF（drug master file）:药物主文件或原料药档案Drug product：成品药 Drug substance：原料药EEIR（Establishment inspection report）：确定检查报告Electronic signature：电子签名Equipment qualification：对设备，设施，仪器等性能的鉴定Excipients：赋形剂或辅料Excit meeting：现场检查结束会 Extended release: 缓慢释放EMEA（The European Medicines Evaluation Agency）:欧洲医药评审委员会FFinished pharmaceuticals （drug product, finishes product, finished dosage form）:制剂药（成品药）其定义位已原料药为起始物料，加一定的赋形剂，制成具有一定剂型可直接用于治疗的药剂。
FDA,GMP,ICH临床实验专业英语词汇互译
FDA,GMP,ICH临床实验专业英语词汇互译FDA,GMP,ICH临床实验专业英语词汇互译FDA常用词中英对照FDA(food and drug adminisration)美国)食品药品监督管理局NDA(new drug application):新药申请ANDA(abbreviated new drug application):简化新药申请EP(export application):出口药申请(申请出口不被批准在美国销售的药品)treatment IND:研究中的新药用于治疗abbreviated(new)drug:简化申请的新药DMF(drug master file):药物主文件(持有者为谨慎起见而准备的保密资料,可以包括一个或多个人用药物在制备,加工,包装和贮存过程中所涉及的设备,生产过程或物品.只有在DMF 持有者或授权代表以授权书的形式授权给FDA,FDA在审查IND, NDA,ANDA时才能参考其内容)holderMF持有者CFR(code of federal regulation)美国)联邦法规PANEL:专家小组batch production:批量生产;分批生产batch production records:生产批号记录post or pre-market surveillance:销售前或销售后监督informed consent:知情同意(患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验)prescription drug:处方药OTC drug(over—the—counter drug):非处方药U.S. public health service:美国卫生福利部NIH(national institute of health)美国)全国卫生研究所animal trail:动物试验accelerated approval:加速批准standard drug:标准药物investigator :研究人员;调研人员preparing and submitting:起草和申报submission:申报;递交benefit(s):受益risk(s):受害drug product:药物产品drug substance:原料药established name:确定的名称generic name:非专利名称proprietary name:专有名称;INN(international nonproprietary name):国际非专有名称narrative summary: 记叙体概要adverse effect:副作用adverse reaction:不良反应protocol:方案archival copy:存档用副本review copy:审查用副本official compendium:法定药典(主要指USP, NF).USP(the united state pharmacopeia):美国药典(现已和NF合并一起出版)NF(national formulary)美国)国家药品集official=pharmacopeial = compendial:药典的;法定的;官方的agency:审理部门(指FDA)sponsor:主办者(指负责并着手临床研究者)identity:真伪;鉴别;特性strength:规格;规格含量(每一剂量单位所含有效成分的量)labeled amount:标示量regulatory specification:质量管理规格标准(NDA提供)regulatory methodology:质量管理方法(FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤)regulatory methods validation:管理用分析方法的验证(FDA对NDA提供的方法进行验证)Dietary supplement:食用补充品ICH(International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)人用药物注册技术要求国际协调会议ICHuality-质量Q1A(R2): Stability Testing of New Drug Substances and Products (Second Revision)新原料药和制剂的稳定性试验(第二版)Q1B: Photostability Testing of New Drug Substances and Products新原料药和制剂的光稳定性试验Q1C: Stability Testing for New Dosage Forms新制剂的稳定性试验Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products原料药和制剂稳定性试验的交叉和矩阵设计Q1E: Evaluation of Stability Data对稳定性数据的评估处理Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV在气候带III和IV,药物注册申请所提供的稳定性数据Q2A: Text on Validation of Analytical Procedures分析程序的验证Q2B: Validation of Analytical Procedures: Methodology分析程序的验证:方法学Q3A(R): Impurities in New Drug Substances (Revised Guideline)新原料药中的杂质(修订版)Q3B(R): Impurities in New Drug Products (Revised Guideline)新制剂中的杂质(修订版)Q3C: Impurities: Guideline for Residual Solvents杂质:残留溶剂指南Q3C(M): Impurities: Guideline for Residual Solvents (Maintenance)杂质:残留溶剂指南(修改内容)Q4: Pharmacopoeias药典Q4A: Pharmacopoeial Harmonisation 药典的协调Q4B: Regulatory Acceptance of Pharmacopoeial Interchangeability药典互替在法规上的可接受性Q5A: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin来源于人或者动物细胞系的生物技术产品的病毒安全性评估Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products生物技术产品的质量:源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products生物技术产品的质量:生物技术/生物产品的稳定性试验Q5D: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products用于生产生物技术/生物产品的细胞底物的起源和特征描述Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process基于不同生产工艺的生物技术产品/生物产品的可比较性Q6: Specifications for New Drug Substances and Products新原料药和制剂的质量规格Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances质量规格:新原料药和新制剂的检验程序和可接收标准:化学物质Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products质量规格:生物技术/生物产品的检验程序和可接收标准-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:34:00--Q7: Good Manufacturing Practices for Pharmaceutical Ingredients活性药物成份的GMPQ7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients活性药物成份的GMP指南Q8: Pharmaceutical Development药物研发Q9: Quality Risk Management质量风险管理ICH:Safety-安全S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals药物致癌性研究需要的指南S1B: Testing for Carcinogenicity of Pharmaceuticals药物致癌性的检验S1C: Dose Selection for Carcinogenicity Studies of Pharmaceuticals药物致癌性研究之剂量选择S1C(R): Addendum: Addition of a Limit Dose and Related Notes附录:极限剂量和有关注释的的补充S2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals受法规管辖的药物基因毒性检验的特定方面的指南S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals 基因毒性:药物基因毒性检验的标准S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies毒物代谢动力学指南的注释:毒性研究中的全身性暴露量的评估S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies药物代谢动力学:重复剂量的组织分布研究指南S4: Single Dose Toxicity Tests单剂量毒性检验S4A: Duration of Chronic Toxicity Testing in Animals (Rodent and Non-Rodent Toxicity Testing)动物体内慢性毒性持续时间的检验(啮齿动物和非啮齿动物毒性检验)S5A: Detection of Toxicity to Reproduction for Medicinal Products药物对生殖发育的毒性的检验S5B(M): Maintenance of the ICH Guideline on Toxicity to Male Fertility: An Addendum to the Guideline on Detection of Toxicity to Reproduction for Medicinal Products 对男性生殖能力的毒性的指南的变动:药物对生殖发育的毒性的检验指南增加了一个附录S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals生物技术生产的药物的临床前安全评价S7A: Safety Pharmacology Studies for Human Pharmaceuticals人用药的安全药理学研究S7B: The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization(QT Interval Prolongation) By Human Pharmaceuticals药物延迟心室复极化(QT间期)潜在作用的非临床评价S8: Immunotoxicology Studies for Human Pharmaceuticals人用药免疫毒理学研究M3(M): Maintenance of the ICH Guideline on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals药物的对人临床试验的非临床安全研究指南的变动E-Efficacy(有效)E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions对用于无生命危险情况下长期治疗的药物进行临床安全评估的族群暴露量范围E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting临床安全数据管理:速报制度的定义和标准E2B(R): Revision of the E2B(M) ICH Guideline on Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports个案安全报告送交的临床安全数据管理的数据要素指南(E2B(M))的修订版E2B (M): Maintenance of the Clinical Safety Data Management including: Data Elements for Transmission of Individual Case Safety Reports临床安全数据管理的变动包括:个案安全报告送交的数据要素E2B(M): Maintenance of the Clinical Safety Data Management including Questions and Answers临床安全数据管理的变动,包括问答E2C: Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs临床安全数据管理:已上市药品的周期性安全数据更新报告Addendum to E2C: Periodic Safety Update Reports for Marketed DrugsE2C的附录:已上市药品的周期性安全数据更新报告E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting批准后的安全数据管理:速报制度的定义和标准E2E: Pharmacovigilance Planning药物警戒计划E3: Structure and Content of Clinical Study Reports临床研究报告的结构和内容E4: Dose-Response Information to Support Drug Registration支持药品注册的剂量-效应资料E5: Ethnic Factors in the Acceptability of Foreign Clinical Data引入海外临床数据时要考虑的人种因素E6: Good Clinical Practice: Consolidated GuidelineGCP:良好的临床规范:统一的指南E7: Studies in Support of Special Populations: Geriatrics对特定族群的支持的研究:老人病学E8: General Considerations for Clinical Trials对临床试验的总的考虑E9: Statistical Principles for Clinical Trials临床试验的统计原则E10: Choice of Control Group and Related Issues in Clinical Trials临床试验中控制组和有关课题的选择E11: Clinical Investigation of Medicinal Products in the Pediatric Population小儿科药物的临床调查E12A: Principles for Clinical Evaluation of New Antihypertensive Drugs新抗高血压药物的临床评价原则E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs非抗心率失常药物的QT/QTc 间期和致心率失常潜在作用的临床评价Multidisciplinary Guidelines 多学科兼容的指南M1: Medical Terminology医学术语M2: Electronic Standards for Transmission of Regulatory Information (ESTRI)药政信息传递之电子标准M3: Timing of Pre-clinical Studies in Relation to Clinical Trials (See Safety Topics)有关临床试验的临床前研究的时间安排M4: The Common Technical Document (See CTD section for complete Status of the guidelines)通用技术文件(见有关CTD章节)M5: Data Elements and Standards for Drug Dictionaries药物词典的数据要素和标准临床试验常用的英文缩略语TTP: time-to-progression 疾病进展时间SAE: severity Adverse Event 严重不良事件AE: Adverse Event 不良事件-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:34:00--SOP: Standard Operating Procedure 标准操作规程CRF: Case Report form 病例报告表DLT: 剂量限制毒性MTD: 最大耐受剂量KPS: Karnofsky Performance Status行为状态评分CR: complete response完全缓解PR: partial response部分缓解SD: 病情稳定PD: progressive disease病情进展CTC: 常用药物毒性标准IEC: independent ethics committee 独立伦理委员会IRB : institutional review board 伦理委员会CRA: 临床研究助理CRO: Contract Research Organization 合同研究组织DFS: Disease Free Survival 无病生存期OS: (Overall Survival) 总生存时间IC: Informed consent 知情同意ADR: Adverse Drug Reaction 不良反应GAP:Good Agricultural Practice 中药材种植管理规范GCP:Good Clinical Practice 药物临床试验质量管理规范GLP:Good Laboratory Practice 药品实验室管理规范GMP:Good Manufacturing Practice 药品生产质量管理规范GSP:Good Supply Practice 药品经营质量管理规范GUP:Good Use Practice 药品使用质量管理规范PI rincipal investigator 主要研究者CI: Co-inveatigator 合作研究者SI :Sub-investigator 助理研究者COI :Coordinating investigtor 协调研究者DGMP: 医疗器械生产质量管理规范ICF: Informed consent form 知情同意书RCT : randomized controlled trial, 随机对照试验NRCCT: non-randomized concurrent controlled trial, 非随机同期对照试验EBM: evidence-based medicine 循证医学RCD: randomized cross-over disgn 随机交叉对照试验HCT: historial control trial, 历史对照研究RECIST: Response Evaluation Criteria In Solid Tumors. 实体瘤疗效反应的评价标准QC: Quality Control质量控制UADR: Unexpected Adverse Drug Reaction,非预期药物不良反应-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:34:00--GMP英语PIC/S的全称为harmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme, PIC/S(制药检查草案), 药品检查协会(PIC/S) ,也有人称PIC/S为医药审查会议/合作计划(PIC/S)PIC的权威翻译:药品生产检查相互承认公约API(Active Pharmaceutical Ingrediet) 原料药又称:活性药物组分AirLock 气闸Authorized Person 授权人Batch/Lot 批次Batch Number/Lot-Number 批号;Batch Numbering System 批次编码系统;Batch Records 批记录;Bulk Product 待包装品;Calibration 校正;Clean area洁净区;Consignmecnt(Delivery)托销药品.ABPI Association of the British Pharmaceutical IndustryADR Adverse Drug ReactionAE Adverse EventAIM Active Ingredient ManufacturerANDA Abbreviated New Drug ApplicationANOVA Analysis of VarianceASM: Active Substance ManufacturerATC Anatomical Therapeutic ChemicalATX Animal Test Exemption CertificateBANBritish Approved NameBIRABritish Institute of Regulatory AffairsBNF British National FormularyBP British PharmacopoeiaC of A Certificate of AnalysisC of S Certificate of SuitabilityCENTRE FOR DRUG EVALUATION (CDE)Centre for Pharmaceutical Administration (CPA)CMS Concerned Member StateCMS每个成员国COS Certificate of SuitabilityCPMP Committee for Proprietary Medicinal ProductsCRA Clinical Research AssociateCRF Case Report FormCRO Contract Research OrganisationCTA Clinical Trial ApplicationCTC Clinical Trial CertificateCTD Common Technical DocumentCTX Clinical Trials ExemptionDDD Defined Daily DoseDGC Daily Global ComparisonDIA Drug Information AssociationDMF Drug Master FileDrug Registration Branch (DR, Product Evaluation & Registration Division, CPA EDQM (European Directorate for the Quality of Medicines) 欧洲联盟药品质量指导委员会EEA 欧洲经济地区EGMA European Generics Medicine AssociationELA Established Licence ApplicationEMEA European Medicines Evaluation AgencyEMEA (European Agency for the Evaluation of Medicinal Products) 欧洲联盟药品评价机构EP European PharmacopoeiaEPAR European Public Assessment ReportsESRA European Society of Regulatory AffairsEuropean Pharmacopoeia Commission 欧洲药典委员会FDA Food and Drug Administrationfinal evaluation report (FER)free sale certificates (FSCs)Health Sciences Authority (HSA)HSA's Medicines Advisory Committee (MAC)IB Investigators BrochureICH International Conference for HarmonisationIDMC Independent Data-Monitoring CommitteeIEC Independent Ethics CommitteeIND Investigational New DrugINN International Non-proprietary NameInternational Conference on Harmonisation (ICH)IPC In Process ControlIRB Institutional Review BoardLICENCE HOLDERMA Marketing AuthorisationMAA Marketing Authorisation ApplicationMAA上市申请MAH Marketing Authorisation HolderMAH 销售许可持有者MCA Medicines Control AgencyMHW Ministry of Health and Welfare (Japan)MR Mutual RecognitionMRA 美国与欧盟的互认协议MRAs (Mutual Recognition Agreements) 互相认证同意MRFG Mutual Recognition Facilitation Group MRPMutual Recognition ProcedureNASNew Active SubstanceNCENew Chemical EntityNDANew Drug Applicationnew chemical entities (NCEs)new drug applications (NDAs)NSAID Non Steroidal Anti Inflammatory DrugNTA Notice To ApplicantsOOS Out of SpecificationOTC Over The CounterPAGB Proprietary Association of Great BritainPh Eur European PharmacopoeiaPIL Patient Information LeafletPL Product LicencePOM Prescription Only MedicinePRODUCT OWNERPSU Periodic Safety UpdatesQA Quality AssuranceQC Quality ControlRAJ Regulatory Affairs JournalRMS Reference Member StateRMS相互认可另一成员国RSD Relative Standard DeviationRx Prescription OnlySAE Serious Adverse EventSMF Site Master FileSOP Standard Operating ProcedureSOP (STANDARD OPERATION PROCEDURE) 标准运作程序SPC/SmPC Summary of Product Characteristics summary of product characteristics(SPC)Therapeutic Goods Administration (TGA)USP US PharmacopoeiaVMF Veterinary Master FileVPC Veterinary Products CommitteeA.A.A Addition and Amendments 增补和修订AC Air Conditioner 空调器ADR Adverse Drug Reaction 药物不良反应AFDO Association of Food and Drug Officials 食品与药品官员协会(美国) ACC Accept 接受AQL Acceptable Quality Level 合格质量标准ADNA Abbreviated New Drug Application 简化的新药申请BOM Bill of Material 物料清单BPC Bulk pharmaceutical Chemiclls 原料药CBER Center for Biologics Evaluation Research 生物制品评价与研究中心CFU Colony Forming Unet 菌落形成单位DMF Drug Master File 药品管理档案CDER Cemter for Drug Evaluation amd Research 药物评价与研究中心CI Corporate Identity (Image) 企业识别(形象)CIP Cleaning in Place 在线清洗CSI Consumer Safety Insepctor 消费者安全调查员CLP Cleaning Line Procedure 在线清洗程序DAL Defect Action Level 缺陷作用水平DEA Drug Enforcement Adminestration 管制药品管理DS Documentation Systim 文件系统FDA Food and Drug Administration 食品与药品管理局(美国)GATT General Agreemernt on Tariffs and Trade 关贸总协会GMP Good Manufacturing Practice Gvp 药品生质量管理规范GCP Good Clinical Practice 药品临床实验管理规范GLP Good Laboratory Practice 实验室管理规范GSP Good Supply Practice 药品商业质量规范GRP Gook RaTAIL Practice 药品零业质量管理规范GAP Good Agriculture Practice 药材生产管理规范GVP Gook Validation Prctice 验证管理规范GUP Gook Use Practice 药品重用规范HVAC Heating Ventilation Air Conditioning 空调净化系统ISO Intematonal Organization for Standardization 车际标准化组织MOU Memorandum of Understanding 谅解备忘录PF Porduction File 生产记录用表格OTC Over the Counter (Drug) 非处方药品PLA Product License Application 产品许可申请QA Quality Assurance 质量保证QC Quality Control 质量控制QMP Quality Management Procedure 质量管理程序SDA State Drug Administration 国家药品监督管理局SMP Standard Managmert Procedure 标准管理程序SOP Standard Operating Procedure 标准操作程序TQC Tatal Quality Control 全面质量管理USA Uneted States Pharmacopeia 美国药典-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:35:00--ICH 安全性领域常用专业术语中英文对照表Dead offspring at birth 出生时死亡的子代Degradation 降解 Delay of parturition 分娩延迟Deletion 缺失 Descriptive statistics 描述性统计 Distribution 分布Detection of bacterial mutagen 细菌诱变剂检测 Detection of clastogen 染色体断裂剂检测Determination of metabolites 测定代谢产物 Development of the offspring 子代发育Developmental toxicity 发育毒性 Diminution of the background lawn 背景减少Direct genetic damage 直接遗传损伤DNA adduct DNA加合物 DNA damage DNA损伤DNA repair DNA修复 DNA strand breaks DNA链断裂Dose escalation 剂量递增 Dose dependence 剂量依赖关系 Dose level 剂量水平Dose-limiting toxicity 剂量限制性毒性 Dose-raging studies 剂量范围研究Dose-relatived mutagenicity 剂量相关性诱变性 Dose-related 剂量相关Dose-relatived cytotoxicity 剂量相关性细胞毒性Dose-relatived genotoxic activity 剂量相关性遗传毒性Dose-response curve 剂量-反应曲线 Dosing route 给药途径Duration 周期 Duration of pregnancy 妊娠周期Eaning 断奶 Earlier physical malformation 早期躯体畸形Early embryonic development 早期胚胎发育Early embryonic development to implantation 着床早期的胚胎发育Electro ejaculation 电射精Elimination 清除Embryofetal deaths 胚胎和胎仔死亡 Embryo-fetal development 胚胎-胎仔发育Embryo-fetal toxicity 胚胎-胎仔毒性 Embryonic death 胚胎死亡Embryonic development 胚胎发育 Embryonic period 胚胎期Embryos 胚胎 Embryotoxicity 胚胎毒性Enantiomer 对映异构体End of pregnancy 怀孕终止 Endocytic 内吞噬(胞饮)Endocytic activity 内吞噬活性 Endogenous proteins 内源性蛋白Endogenous components 内源性物质 Endogenous gene 内源性基因Endonuclease 核酸内切酶 Emdpmiclease release from lysosomes 溶酶体释放核酸内切酶End-point 终点Epididymal sperm maturation 附睾精子成熟性 Epitope 抗原决定部位Error prone repair 易错性修复 Escalation 递增Escherichia coli strain 大肠杆菌菌株 Escherichia coli 大肠杆菌Evaluation of test result 试验结果评价Exaggerated pharmacological response 超常增强的药理作用Excretion 排泄(清除) Exposure assessment 接触剂量评价Exposure period 接解期 External metabolizing system 体外代谢系统F1-animals 子一代动物False positive result 假阳性结果Fecundity 多产 Feed-back 反馈 Fertilisation 受精 Fertility 生育力Fertility studies 生育力研究 Fetal abnormalities 胎仔异常Fetal and neonatal parameters 胎仔和仔鼠的生长发育参数Fetal development and growth 肿仔发育和生长 Fetal period 胎仔期 Fetotoxicity 胎仔毒性False negative result 假阴性结果First pass testing 一期试验Fluorescence in situ hybridization(FISH) 原位荧光分子杂交-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:35:00--average deviation 平均差Bbar chart 直条图,条图bias 偏性binomial distribution 二项分布biometrics 生物统计学bivariate normal population 双变量正态总体Ccartogram 统计图case fatality rate(or case mortality) 病死率census 普查chi-sguare(X2) test 卡方检验central tendency 集中趋势class interval 组距classification 分组,分类cluster sampling 整群抽样coefficient of correlation 相关系数coefficient of regression 回归系数coefficient of variability(or coefficieut of variation) 变异系数collection of data 收集资料column 列(栏)combinative table 组合表combined standard deviation 合并标准差combined variance(or poolled variance) 合并方差complete survey 全面调查completely correlation 完全相关completely random design 完全随机设计confidence level 可信水平,置信水平confidence limit 可信限,置信限constituent ratio 构成比,结构相对数continuity 连续性control 对照control group 对照组coordinate 坐标correction for continuity 连续性校正correction for grouping 归组校正correction number 校正数correction value 校正值correlation 相关,联系correlation analysis 相关分析correlation coefficient 相关系数critical value 临界值cumulative frequency 累积频率Ddata 资料degree of dispersion 离散程度degree of freedom 自由度degree of variation 变异度dependent variable 应变量design of experiment 实验设计deviation from the mean 离均差diagnose accordance rate 诊断符合率difference with significance 差别不显著difference with significance 差别显著discrete variable 离散变量dispersion tendency 离中趋势distribution 分布,分配-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:35:00--Eeffective rate 有效率eigenvalue 特征值enumeration data 计数资料equation of linear regression 线性回归方程error 误差error of replication 重复误差estimate value 估计值event 事件experiment design 实验设计experiment error 实验误差experimental group 实验组extreme value 极值Ffatality rate 病死率field survey 现场调查fourfold table 四格表freguency 频数freguency distribution 频数分布GGaussian curve 高斯曲线geometric mean 几何均数grouped data 分组资料Hhistogram 直方图homogeneity of variance 方差齐性homogeneity test of variances 方差齐性检验hypothesis test 假设检验hypothetical universe 假设总体Iincidence rate 发病率incomplete survey 非全面调检indepindent variable 自变量indivedual difference 个体差异infection rate 感染率inferior limit 下限initial data 原始数据inspection of data 检查资料intercept 截距interpolation method 内插法interval estimation 区间估计inverse correlation 负相关Kkurtosis coefficient 峰度系数Llatin sguare design 拉丁方设计least significant difference 最小显著差数least square method 最小平方法,最小乘法leptokurtic distribution 尖峭态分布leptokurtosis 峰态,峭度linear chart 线图linear correlation 直线相关linear regression 直线回归linear regression eguation 直线回归方程link relative 环比logarithmic normal distribution 对数正态分布logarithmic scale 对数尺度lognormal distribution 对数正态分布lower limit 下限Mmatched pair design 配对设计mathematical statistics 数理统计(学) maximum value 极大值mean 均值mean of population 总体均数mean square 均方mean variance 均方,方差measurement data 讲量资料median 中位数medical statistics 医学统计学mesokurtosis 正态峰method of least squares 最小平方法,最小乘法method of grouping 分组法method of percentiles 百分位数法mid-value of class 组中值minimum value 极小值mode 众数moment 动差,矩morbidity 患病率mortality 死亡率Nnatality 出生率natural logarithm 自然对数negative correlation 负相关negative skewness 负偏志no correlation 无相关non-linear correlation 非线性相关non-parametric statistics 非参数统计normal curve 正态曲线normal deviate 正态离差normal distribution 正态分布normal population 正态总体normal probability curve 正态概率曲线normal range 正常范围normal value 正常值normal kurtosis 正态峰normality test 正态性检验nosometry 患病率-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:35:00--Oobserved unit 观察单位observed value 观察值one-sided test 单测检验one-tailed test 单尾检验order statistic 顺序统计量ordinal number 秩号ordinate 纵坐标Ppairing data 配对资料parameter 参数percent 百分率percentage 百分数,百分率percentage bar chart 百分条图percentile 百分位数pie diagram 园图placebo 安慰剂planning of survey 调查计划point estimation 点估计population 总体,人口population mean 总体均数population rate 总体率population variance 总体方差positive correlation 正相关positive skewness 正偏态prevalence rate 患病率probability 概率,机率probability error 偶然误差proportion 比,比率prospective study 前瞻研究prospective survey 前瞻调查public health statistics 卫生统计学Qquality eontrol 质量控制quartile 四分位数Rrandom 随机random digits 随机数字random numbers table 随机数目表random sample 随机样本random sampling 随机抽样random variable 随机变量randomization 随机化randomized blocks 随机区组,随机单位组randomized blocks analysis of variance 随机单位组方差分析randomized blocks design 随机单位组设计randomness 随机性range 极差,全距range of normal values 正常值范围rank 秩,秩次,等级rank correlation 等级相关rank correlation coefficent 等级相关系数rank-sum test 秩和检验ranked data 等级资料rate 率ratio 比recovery rate 治愈率registration 登记regression 回归regression analysis 回归分析regression coefficient 回归系数regression eguation 回归方程relative number 相对数relative ratio 比较相对数relative ratio with fixed base 定基比remainder error 剩余误差replication 重复retrospective survey 回顾调查Ridit analysis 参照单位分析Ridit value 参照单位值Ssample 样本sample average 样本均数sample size 样本含量sampling 抽样sampling error 抽样误差sampling statistics 样本统计量sampling survay 抽样调查scaller diagram 散点图schedule of survey 调查表semi-logarithmic chart 半对数线图semi-measursement data 半计量资料semi-guartile range 四分位数间距sensitivity 灵敏度sex ratio 性比例sign test 符号检验significance 显著性,意义significance level 显著性水平significance test 显著性检验significant difference 差别显著simple random sampling 单纯随机抽样simple table 简单表size of sample 样本含量skewness 偏态slope 斜率sorting data 整理资料sorting table 整理表sources of variation 变异来源square deviation 方差standard deviation(SD) 标准差standard error (SE) 标准误standard error of estimate 标准估计误差standard error of the mean 均数的标准误standardization 标准化standardized rate 标化率standardized normal distribution 标准正态分布statistic 统计量statistics 统计学statistical induction 统计图statistical inference 统计归纳statistical map 统计推断statistical method 统计地图statistical survey 统计方法statistical table 统计调查statistical test 统计表statistical treatment 统计检验stratified sampling 统计处理stochastic variable 分层抽样sum of cross products of 随机变量deviation from mean 离均差积和sum of ranks 秩和sum of sguares of deviation from mean 离均差平方和superior limit 上限survival rate 生存率symmetry 对称(性)systematic error 系统误差systematic sampling 机械抽样-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:35:00--Tt-distribution t分布t-test t检验tabulation method 划记法test of normality 正态性检验test of one-sided 单侧检验test of one-tailed 单尾检验test of significance 显著性检验test of two-sided 双侧检验test of two-tailed 双尾检验theoretical frequency 理论频数theoretical number 理论数treatment 处理treatment factor 处理因素treatment of date 数据处理two-factor analysis of variance 双因素方差分析two-sided test 双侧检验two-tailed test 双尾检验type I error 第一类误差type II error 第二类误差typical survey 典型调查Uu test u检验universe 总体,全域ungrouped data 未分组资料upper limit 上限Vvariable 变量variance 方差,均方variance analysis 方差分析variance ratio 方差比variate 变量variation coefficient 变异系数velocity of development 发展速度velocity of increase 增长速度Wweight 权数weighted mean 加权均数Zzero correlation 零相关-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:36:00--世界500强制药企业名称中英对照排名公司名称中文名称总部收入百万美元77 Pfizer 辉瑞美国 45950.092 Johnson & Johnson 强生美国 41862.0114 GlaxoSmithKline 葛兰素史克英国 35050.9193 Novartis 诺华瑞士 24864.0205 Roche Group 罗氏瑞士 23212.9222 Merck 默克美国 22485.9239 Bristol-Myers Squibb 百时美施贵宝美国 20894.0 248 Aventis 安万特法国 20162.4254 Abbott Laboratories 雅培美国 19680.6269 AstraZeneca 阿斯利康英国 18849.0330 Wyeth 惠氏美国 15850.6433 Eli Lilly 礼来大药厂美国 12582.5100 BASF 巴斯夫德国 37757.0125 Dow Chemical 道化学美国 32632.0129 Bayer 拜耳德国 32331.1365 Akzo Nobel 阿克苏诺贝尔荷兰 14770.7。
美国仿制药用户收费法案(GDUFA)
4160-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration[Docket No. FDA-2012-N-0007]Generic Drug User Fee--Abbreviated New Drug Application, Prior Approval Supplement, and Drug Master File Fee Rates for Fiscal Year 2013AGENCY: Food and Drug Administration, HHS.ACTION: Notice.SUMMARY: The Food and Drug Administration (FDA) is announcing the rate for the abbreviated new drug application (ANDA), prior approval supplement (PAS), and drug master file (DMF) fees related to the Generic Drug User Fee Program for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), as further amended by the FDA User Fee Correction Act of 2012, authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on applications in the backlog as of October 1, 2012, on finished dosage form (FDF) and active pharmaceutical ingredient (API) facilities, and on type II active pharmaceutical ingredient DMFs to be made available for reference. GDUFA directs FDA to establish each year the Generic Drug User Fee rates for the upcoming year. In the first year of GDUFA (FY 2013), some rates will be published in separate Federal Register notices because of the timing specified in the statute. Each year thereafter the GDUFA fee rates will be published 60 days before the start of the FY. This document establishes FY 2013 rates for an ANDA ($51,520), PAS ($25,760), and DMF ($21,340). These fees are effective on October 1, 2012, and will remain in effect through September 30, 2013.FOR FURTHER INFORMATION CONTACT:David Miller,Office of Financial Management (HFA-100),Food and Drug Administration,1350 Piccard Dr., PI50, rm. 210J,Rockville, MD 20850,301-796-7103.SUPPLEMENTARY INFORMATION:I. BackgroundSections 744A and 744B of the FD&C Act (21 U.S.C. 379j-41 and 379j-42), as added by GDUFA (Title III of the Food and Drug Administration Safety and Innovation Act (Public Law 112-144), which was signed by the President on July 9, 2012), as further amended by the FDA User Fee Correction Act of 2012 (Public Law 112-193) (signed by the President on October 5, 2012), establish fees associated with human generic drug products. Fees are assessed on the following: (1) Certain applications in the backlog as of October 1, 2012; (2) certain types of applications and supplements for human generic drug products; (3) certain facilities where APIs and FDFs are produced; and (4) certain DMFs associated with human generic drug products (section 744B(a) of the FD&C Act). This notice will focus on the ANDA, PAS, and DMF fees.II. Fee Revenue Amount for FY 2013The total fee revenue amount for FY 2013 is $299,000,000, as set in the statute. GDUFA directs FDA to use the yearly revenue amount as a starting point to set the fee rates for each fee type. GDUFA states that the backlog fee will make up $50,000,000 of the total revenue collected for FY 2013. Therefore, the rest of the fees will make up a percentage of the remaining$249,000,000 of the total revenue. For more information about GDUFA, please refer to the FDA Web site (/gdufa). The ANDA, PAS, and DMF fee calculations for FY 2013 are described in this document.III. ANDA and PAS FeesUnder GDUFA, the ANDA and PAS fees are owed by each applicant that submits, on or after October 1, 2012, an ANDA or a PAS. These fees are due on the date of submission of the ANDA or PAS or 30 days after the publication date of this notice, whichever is later. Section 744B(b)(2)(B) specifies that the ANDA and PAS fees will make up 24 percent of the$249,000,000, which is $59,760,000.In order to calculate the ANDA fee, FDA needed to estimate the number of full application equivalents (FAEs) that will be submitted in FY 2013. Over the past 4 years, the average number of ANDAs that would have been subject to the fee was approximately 850. Because the number of prior approval supplements submitted in FY 2012 is significantly lower than the number submitted in the 2 previous years, FDA has utilized available data concerning FY 2012 to estimate the number of such supplements for FY 2013. The estimated number of PASs to be received in FY 2013 is 576 based on an annualized estimate of the number of receipts for FY 2012.In estimating the number of fee-paying FAEs, applications count as one FAE and supplements count as one-half an FAE, since the fee for a PAS is one-half of the fee for an ANDA. GDUFA requires that 75 percent of the fees paid for an ANDA or PAS be refunded if its receipt is refused due to issues other than failure to pay fees (section 744B(a)(3)(D) of theFD&C Act). Therefore, an application or supplement that is considered not to have been received by the Secretary due to reasons other than failure to pay fees counts as one-fourth of anFAE if the applicant initially paid a full application fee, or one-eighth of an FAE if the applicant initially paid the supplement fee (one-half of the full application fee amount).Taking into account estimates of the number of ANDAs and PASs that are likely to be refused due to issues other than failure to pay fees, and the number that are likely to be resubmitted in the same fiscal year, FDA estimates that the total number of fee-paying FAEs that will be received in FY 2013 is 1,160.The FY 2013 application fee is estimated by dividing the number of full application equivalents that will pay the fee in FY 2013 (1,160) into the fee revenue amount to be derived from application fees in FY 2013 ($59,760,000). The result, rounded to the nearest $10, is a fee of $51,520 per ANDA. Section 744B(b)(2)(B) of the FD&C Act states that the PAS fee is equal to half the ANDA fee; therefore the PAS fee is $25,760. We note that the statute provides that those ANDAs that include information about the production of active pharmaceutical ingredients other than by reference to a DMF will pay an additional fee that is based on the number of such active pharmaceutical ingredients and the number of facilities proposed to produce those ingredients. (See section 744B(a)(3)(F) of the FD&C Act.) FDA considers this additional fee to be unlikely to be assessed often; therefore, FDA has not included projections concerning the amount of this fee in calculating the fees for ANDAs and PASs.IV. DMF FeeUnder GDUFA, the DMF fee is owed by each person that owns a type II active pharmaceutical ingredient drug master file that is referenced, on or after October 1, 2012, in a generic drug submission by an initial letter of authorization. This is a one-time fee for each individual DMF. This fee is due no later than the date on which the first generic drug submission is submitted that references the associated DMF, or 30 days after publication of this notice, whichever is later. (Under section 744B(a)(2)(D)(iii) of the FD&C Act, if the DMF successfully undergoes an initial completeness assessment and the fee is paid, the DMF will be placed on a publicly available list documenting DMFs available for reference. Thus some DMFs holders may choose to pay the fee prior to the date that it would otherwise be due in order to have the DMF placed on that list.) Section 744B(b)(2)(A) of the FD&C Act specifies that the DMF fee will make up 6 percent of the remaining $249,000,000, which is $14,940,000.In order to calculate the DMF fee, FDA must estimate the number of DMFs that will be referenced by an initial letter of reference in FY 2013. This number will include DMFs that have been referred to in ANDAs prior to FY 2013, but that are first referred to in an initial letter of reference in an ANDA during that year. Based on the numbers of DMFs referenced by ANDAs and PASs in 2011, the last full calendar year for which DMF information is available, FDA is estimating that 700 DMFs will be referenced by an initial letter of reference in FY 2013. Dividing the DMF revenue of $14,940,000 by the estimated number of first-referenced DMFs (700), and rounding to the nearest $10, yields a DMF fee of $21,340 for FY 2013.V. Fee Payment Options and ProceduresTo pay the ANDA, PAS, or DMF fee, you must complete a generic drug user fee cover sheet, available at /gdufa starting in October 2012, and generate a user feeidentification (ID) number. Payment must be made in U.S. currency drawn on a U.S. bank by electronic check, check, bank draft, U.S. postal money order, or wire transfer.FDA has partnered with the U.S. Department of the Treasury to utilize , a Web-based payment application, for online electronic payment. The feature is available on the FDA Web site after completing the generic drug user fee cover sheet and generating the user fee ID number.Please include the user fee ID number on your check, bank draft, or postal money order and make payable to the order of the Food and Drug Administration. Your payment can be mailed to: Food and Drug Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If checks are to be sent by a courier that requests a street address, the courier can deliver the checks to: U.S. Bank, Attention: Government Lockbox 979108, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery only.) Please make sure that the FDA post office box number (P.O. Box 979108) is written on the check, bank draft, or postal money order.If paying by wire transfer, please reference your unique user fee ID number when completing your transfer. The originating financial institution may charge a wire transfer fee. Please ask your financial institution about the fee and include it with your payment to ensure that your fee is fully paid. The account information is as follows: New York Federal Reserve Bank, U.S. Department of Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, account number: 75060099, routing number: 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 1350 Piccard Dr., Rockville, MD, 20850. The tax identification number of the Food and Drug Administration is 53-0196965.Dated: October 16, 2012.Leslie Kux,Assistant Commissioner for Policy.[FR Doc. 2012-26256 Filed 10/24/2012 at 8:45 am; Publication Date: 10/25/2012]。
FDA仿制药申报者付费法案
• Facility Fees
– Involved in manufacture of generic drugs, whether API or Finished Dosage Form, domestic or foreign
• Individual fees calculated/published upon implementation • Fees not linked to types of services; rather overall goals
• Members worldwide
– 16 all-day negotiation sessions using a highly transparent process
• Negotiation summaries on public Web site
• Open docket througtters • Division-level deficiency review • Rolling review • First cycle meetings
– 200 in FY 2015 – 250 in FY 2016 – 300 in FY 2017
Fee Estimates: Public Stakeholder Meeting
• Estimates Only
– Backlog ~ $25K – DMF ~$40K – ANDA ~ $60K – Supplement ~ $30K
• for PAS only; $0 for changes being effected (CBE)
Focusing on Doing the Most Good
• • Four walls and a roof Limit cost
FDA 仿制药指南,都在这里
FDA 仿制药指南，都在这里中国是化学仿制药大国，自建国以来，中国上市的新药绝大多数为仿制产品；但现代仿制药的规范化起源，却是来自美国。
在美国，1984年通过的Hatch-Waxman法案，建立了鼓励药物创新与仿制药竞争的双重机制。
该法案案的重要贡献在于鼓励仿制药发展，促进仿制药上市并降低药价，开创了简略新药申请（ANDA）、专利挑战及首仿药市场独占期等制度，有效平衡了药物创新与仿制药开发。
就仿制药评估、一致性评价、CMC、标签、注册申请及与FDA沟通等主题，FDA发布了一些列相关指南，代表了其在仿制药上的监管考量。
在仿制药国际化进程的道路上，这些指南对于国内有着重要的学习价值。
对于出口型药企，是开拓美国仿制药市场的“必修课”；同时由于这些指南的普适性价值，对于其它药企，也有着重要的参考意义。
指南汇编PharmLink对众多FDA指南进行了整理，完成了仿制药相关主题的汇编，并对每个指南进行中英文提要说明。
该汇编由两部分组成：1）中英文提要总结与索引文件（共48页），示例如下：2）FDA指南原文（共52个）本套汇编共计8大系列（52个指南）：1：行政/程序性指南Administrative/Procedural2：使用者费用User Fees3：评估原则Principles for Evaluating4：化学、生产和控制Chemistry, Manufacturing, and Controls 5：临床与生物等效性GCP and Bioequivalence6：标签Labeling7：注册申请Submission8：信函与会议Correspondence and Meeting汇编简介系列1：行政/程序性指南Administrative/Procedural本部分收录了FDA关于仿制药的特殊行政/程序性规定，包括竞争性仿制疗法和180天的市场独占期等：- FDA可以应申请人的要求，将“仿制竞争不足”的药品指定为竞争性仿制疗法(CGT)。
FDA公布2014财年仿制药企业付费修正案(GDUFA)付费标准
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美国人用兽用仿制药FY2014 user fee rate
美国人美国人用用兽用仿制用仿制药药user fee rate FY 2014国际贸易出身的法规事务学习者Vita和你共同解决药品出口问题欧美出口无障碍Vita Hao (CEO adviser)Vita Pharma Supplement vitahaohao@ Skype:haovita@ You will get benefit from my work:Analysis:Customers,Competitors,SuppliersMarket Development:Marketing API or FDF to DEVELOPED COUNTRIES Supplier Development:Purchasing API or FDF RA:DMF/VMF/COS/ANDA/ANADA/MAA第1页共1页Generic Drug User Fee Act (GDUFA)Abbreviated New Drug Application $63,860Prior Approval Supplement $31,930Drug Master File$31,460Foreign Facility Fee Differential$15,000Finished Dosage Form Facility (Domestic)$220,152Finished Dosage Form Facility (Foreign)$235,152Active Pharmaceutical Ingredient Facility (Domestic)$34,515Active Pharmaceutical Ingredient Facility (Foreign)$49,515Animal Generic Drug User Fee Act (AGDUFA)Abbreviated Application Fee for Generic New Animal Drug except those subject to the criteria in section 512(d)(4)$177,900Abbreviated Application Fee for Generic New Animal Drug subject to the criteria in section 512(d)(4)$88,950Generic New Animal Drug Product Fee$8,035Sponsor Fee (Seven or More Approved Products)$72,800Sponsor Fee (Three or More Approved Products)$54,600Sponsor Fee (One or Fewer Approved Products)$36,400。
FDA仿制药费用(GDUFA)支付(中英文)
以下内容原文FDA官网网址：/ForIndustry/UserFees/GenericDrugUserFees/ucm322629.htmGeneric Drug User Fee Cover Sheet and Payment Information仿制药费用封面页和支付信息The Generic Drug User Fee Amendments of 2012 authorizes FDA to assess and collect user fees for human generic drug applications, certain application supplements, and related manufacturers. Form FDA 3794, also known as the Generic Drug User Fee Cover Sheet or GDUFA Cover Sheet, is designed to collect the minimum necessary information to determine the total applicable user fee required and to help FDA track the user fee payments. Furthermore, FDA’s review of a generic drug submission cannot begin until all relevant user fee obligations have been satisfied.2012仿制药用户费用修正案赋予了FDA权利评估和收取人用仿制药申请、特定的申请增补和相关生产商用户费用。
为此FDA设计了3794表格，即GDUFA封面页，用于收集基本信息以决定总的用户费用，并帮助FDA跟踪用户费用的支付。
美国仿制药用户付费制度FDA确认信
美国仿制药用户付费制度FDA确认信FDA-Industry Generic Drug User Fee (GDUF)Announcement of Ratification; Next StepsSeptember 9, 2011________________________________________________________________ _______ Announcement of RatificationThe Food and Drug Administration is pleased to announce the ratification by FDA and each of the three industry trade associations participating in the generic drug user fee negotiations of a goals letter and proposed legislative language. These documents have been carefully negotiated between FDA, the Generic Pharmaceutical Association, the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturers and Affiliates, and the European Fine Chemicals Group, in a series of negotiation sessions over the last six months.As is the case in the reauthorization process for FDA’s other, already existing, user fee programs, the negotiated documents are not being publicly released at this time, as they now need to undergo review by the Department of Health and Human Services and the White House prior to their public release and their eventual presentation to Congress. However, general outlines of the negotiated program are available from the meeting minutes that have been regularly posted during the negotiations.Minutes of negotiation sessions can be found at the following webpage:/doc/19654314.html,/ForIndustry/Use rFees/GenericDrugUserFees/ucm256662.htm Additional information on the need for and process of negotiating a genericdrug user fee program, and materials from FDA’s public meetings and stakeholder updates on the process can be found at the following webpage:/doc/19654314.html,/ForIndustry/Use rFees/GenericDrugUserFees/default.htmNext StepsThe goals letter and proposed legislative language will now be provided to the Department of Health and Human Services for review, and will thereafter be provided to the Office of Management and Budget for review. The agency will post the final cleared goals letter and proposed legislative language for the generic drug user fee program upon receiving clearance from OMB, as the agency does in its other user fee negotiations. FDA anticipates providing a generic drug user fee package to congress in January, accompanying the reauthorization packages for FDA’s other user fees.。
FDA指南草案 GDUFA
201210 FDA指南草案：二类原料药DMF在GDUFA下的首次完整性审核（中英文）Guidance for Industry行业指南Initial Completeness Assessments for Type II API DMFs Under GDUFAGDUFA下二类原料药DMF的首次完整性审核DRAFT GUIDANCEThis guidance document is being distributed for comment purposes only.本草案仅供征求建议Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.关于本草案的建议和意见可以在公布后60天内提交至文件管理中心（HFA-305)，食品药品管理局For questions regarding this draft document contact Division of Drug Information at1-866-405-5367.U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)October 2012Generic DrugsGuidance for IndustryInitial Completeness Assessments for Type II API DMFs Under GDUFAAdditional copies are available from:Office of Communications, Division of Drug InformationCenter for Drug Evaluation and ResearchFood and Drug Administration10903 New Hampshire Ave., Bldg. 51, rm. 2201Silver Spring, MD 20993-0002Tel: 301-796-3400; Fax: 301-847-8714; E-mail: druginfo@/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)October 2012TABLE OF CONTENTS 目录I. INTRODUCTION 概述 (1)II. BACKGROUND 背景 (2)III. INITIAL COMPLETENESS ASSESSMENT 首次完整性审核 (2)A. Information Confirmed During the Initial Completeness Assessment 初审要确认的信息 (3)B. Check of Initial Completeness Assessment Elements 初审要素检查 (4)IV. INITIAL COMPLETENESS ASSESSMENT OUTCOMES初审结果 (4)V. API INFORMATION INCLUDED IN A GENERIC DRUG SUBMISSION仿制药申请中包括的原料药信息 (5)VI. SUMMARY总结 (5)DEFINITIONS定义 (6)APPENDIX 1:附件1 (7)Guidance for Industry[1]行业指南Initial Completeness Assessments for Type II API DMFsUnder GDUFAGDUFA下对二类原料药DMF的首次完整性审核I. INTRODUCTION 概述This draft guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA) or an amendment or prior approval supplement (PAS) to an ANDA (generic drug submissions). The guidance explains that, beginning October 1, 2012, under the Generic Drug User Fee Amendments of 2012, commonly referred to as GDUFA.[2]本指南阅读对象为已经或将要被仿制药ANDA或其增补或预批准变更所引用的二类原料药DMF的持有人。
FDA 21 CFR QSR820 中英文对照版本【范本模板】
21 CFR § 820Quality System Regulation质量体系手册Subpart A—General ProvisionsA部分-—总则820。
1 Scope。
820。
1范围820。
3 Definitions。
定义820。
5 Quality system.质量体系Subpart B—Quality System RequirementsB部分——质量体系要求820.20 Management responsibility。
管理者职责820。
22 Quality audit.质量审核820。
25 Personnel。
职员Subpart C—Design ControlsC部分—-设计控制820.30 Design controls。
设计控制Subpart D—Document ControlsD部分-—文件控制820.40 Document controls.文件控制Subpart E—Purchasing ControlsE部分——采购控制820.50 Purchasing controls。
采购控制Subpart F—Identification and TraceabilityF部分——标识和可追溯性820.60 Identification.标识820。
65 Traceability。
可追溯性Subpart G—Production and Process ControlsG部分—-生产和过程控制820.70 Production and process controls.产品和过程控制820.72Inspection，measuring，and test equipment.检查、测量，测试仪器820。
75 Process validation。
过程确认Subpart H—Acceptance ActivitiesH部分—接收活动820.80 Receiving, in—process, and finished device acceptance。
FDA公布2018财年GDUFA费率
FDA公布2018财年GDUFA费率美国 FDA 公布了 GDUFA II 期第一年的仿制药使用者收费费率。
GDUFA II 收费结构相对于 GDUFA I 有两个根本区别。
首先，GDUFA I 建立在仿制药办公室（OGD）每年接收约 750 件 ANDA 的基础之上。
在过去 5 年的 GDUFA I 期间收到的 ANDA 平均数量超过 1000 件。
因此，FDA 调整了收费以反映在 GDUFA I 下看到的增加的和意料外的工作量。
其次，FDA 首次向仿制药申请人收取所谓的年度项目费，“设想”减轻设施和场地的一些费用。
联邦公报通告中报告的 2018 财年费用如下：收费类别费率申请费：•ANDA申请$171,823•DMF申请$47,829场地费•境内API场地$45,367•境外API场地$60,367•境内FDF场地$211,087•境外FDF场地$226,087•境内CMO场地$70,362•境外CMO场地$85,362GDUFA 项目费•小企业（1-5件ANDA）$159,079•中企业（6-19件）$636,317•大企业（20件及以上）$1,590,792这些费用与 2017 财年 GDUFA I 的收费相比如何？见下表。
收费2017财年ANDA费$70,480PAS费$35,240DMF费$51,140API境内场地费$44,234API境外场地费$59,234FDF境内场地费$258,646FDF境外场地费$273,646请记住，现在没有预先批准补充申请（PAS）费，取而代之的是项目费。
当查看费用的差别时，很难看出新的收费结构如何看起来不像是真正缓解了任何压力，但确实将一些成本转移到更大的公司身上。
我们将继续观察企业对新收费结构的反应。
FDA 估计将有 938 件至 948 件新原始 ANDA 在 2018 财年申报并缴纳申请费。
请阅读联邦公报通告以了解 FDA 如何确定所有不同的费用以及相关付费方式的完整解释。
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以下内容原文FDA官网网址：/ForIndustry/UserFees/GenericDrugUserFees/ucm322629.htmGeneric Drug User Fee Cover Sheet and Payment Information仿制药费用封面页和支付信息The Generic Drug User Fee Amendments of 2012 authorizes FDA to assess and collect user fees for human generic drug applications, certain application supplements, and related manufacturers. Form FDA 3794, also known as the Generic Drug User Fee Cover Sheet or GDUFA Cover Sheet, is designed to collect the minimum necessary information to determine the total applicable user fee required and to help FDA track the user fee payments. Furthermore, FDA’s review of a generic drug submission cannot begin until all relevant user fee obligations have been satisfied.2012仿制药用户费用修正案赋予了FDA权利评估和收取人用仿制药申请、特定的申请增补和相关生产商用户费用。
为此FDA设计了3794表格，即GDUFA封面页，用于收集基本信息以决定总的用户费用，并帮助FDA跟踪用户费用的支付。
另外，FDA对仿制药申请的审核只有在相关的费用支付后才会开始。
When is the GDUFA Cover Sheet required? 什么时候需要GDUFA封面页？The GDUFA Cover Sheet is required for each of the following human generic drug user fees:以下人用仿制药用户费用，每个费用均需要一个GDUFA封面页：Abbreviated new drug application (ANDA) or applicable amendment;简略新药申请（ANDA）或增补Prior approval supplement (PAS) or applicable amendment;预批准变更申请（PAS）或增补Type II active pharmaceutical ingredient (API) drug master file (DMF) that is referenced on or after October 1, 2012, in a generic drug submission to the FDA and for which the DMF fee has not already been paid;二类活性药用成分（API）药物主文件（DMF），在2012年10月1日之后（含）被仿制药申请所引用，尚未支付DMF费用的Generic drug facility which is identified or intended to be identified in at least one generic drug submission that is pending or approved to produce a finished dosage form (FDF) of a human generic drug or an API contained in a human generic drug; and仿制药工厂，生产或将要生产至少一种人用仿制药制剂，且尚未获得批准的，或生产原料药用于人用仿制药制剂的，和Backlog ANDA which is pending on October 1, 2012, and that has not received a tentative approval prior to that date.在2012年10月1日因等批准而积压的ANDA，和在此日期之前未收到临时批准的ANDANote: A cover sheet is not required for all ANDA and PAS amendments. It is only applicable to an amendment that is adding API manufacturing information other than by reference to a Type II DMF which is subject to the Section 744B(a)(3)(F) fee under GDUFA.注：并不是所有ANDA和PAS增补都需要封面页。
只有当增补中包括增加原料药生产信息而不是引用二类DMF，根据GDUFA才需要缴纳744B(a)(3)(F)费用。
How to fill out a GDUFA Cover Sheet? 如何填写GDUFA封面页？Read the instructions below and then go to Create GDUFA Cover Sheet2 to fill out the form.A GDUFA Cover Sheet will be completed online using F DA’s User Fee System which requires the use of Microsoft Internet Explorer 7.0 or higher.先阅读以下指南，然后登录Create GDUFA Cover Sheet填写表格，该表格需要使用FDA用户费用系统在线填写，需要浏览器为微软IE7.0或更高版本。
Access the User Fee System at Create GDUFA Cover Sheet3.登录Create GDUFA Cover Sheet进入用户费用系统。
Register your organization by providing information about your organization.提供组织机构的信息注册你的组织机构Create a user account for your organization and provide contact information.为你的组织机构创建一个用户帐号，提供联系信息Create a cover sheet by answering a series of questions and making appropriate selections.依次回答问题，进行适当的选择，创建一个封面页Submit the cover sheet to complete the process and determine the user fee amount owed. Upon submission, a User Fee Payment I.D. Number (PIN), which begins with the letters “GD”, is generated. The PIN must be referenced in your payment submission.提交封面页，完成该过程，确认需要支付的用户费用，会产生一个以“GD”开头的用户费用支付ID编号（PIN）。
在进行支付时，必须注明此PIN编号。
Additional instructions for the User Fee System and the process to create a GDUFA Cover Sheet can be located under the Frequently Asked Questions (FAQs)4 within the User Fee System. For detailed instructions to complete the GDUFA Cover Sheet, please access Form FDA 3794 - Instructions5.关于用户费用系统和创建GDUFA封面页的过程更多指南可以在用户费用体系中Frequently Asked Questions (FAQs)上找到。
关于完成GDUFA封面页的更多细节指南，参见Form FDA 3794 - Instructions。
Note: A signed copy of a completed GDUFA Cover Sheet must be included in the following submissions to the FDA: ANDA or PAS submission (placed in the first volume with Form FDA 356h) and Type II API DMF submission.注：在向FDA提交下述申报资料时，必须附入一份已填写完成的GDUFA封面页副本：ANDA或预批准变更申请（放在第一卷，FDA356h表格中）和二类原料药DMF申报。
What information is needed to complete a GDUFA Cover Sheet?要完成GDUFA封面页，需要哪些信息？How are payments submitted? 如何支付费用？A payment may be submitted by (electronic payment), check, bank draft, U.S. postal money order, or wire transfer. For all payment options, the payment must be made in U.S. currency drawn on a U.S.financial institution. FDA recommends that user fee payments be made in a timely manner to meet the required payment due date or to be received prior to an application submission. For application submissions, it is recommended that you send manual payments to the bank 4-5 business days before the application submission arrives at FDA so that there is no delay in starting the review of your application submission. Please follow the instructions below for your selected payment option:费用可以通过 （电子支付）、支票、银行汇票、美国邮政汇票或电汇方式支付。