仿制药的简略新药申请程序（ANDA Process）?前言
?简略新药申请的指南文件
?法律，法规，政策和程序
o美国联邦法典
o政策和程序手册
?ANDA 表格和电子申请
?药品开发和评审定义
?药品开发方面的常见问题
?相关主题
前言
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. 简略新药申请（ANDA）所包括的资料被交至FDA药品评审和研究中心所属的仿制药办公室，用于仿制药的评审和最终批准。Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.一旦批准，则申请者可以生产和销售该仿制药以向美国公众提供安全，有效，廉价的替代品。
A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. 仿制药在剂型，剂量，服用方式，质量，性能特征和用途方法都是和原创药物相当的。All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).所有被批准的药品，包括原创药和仿制药都列在FDA的具有相当疗效评估的已批准药品（橙皮书）上。Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. 仿制药申请被称为“简略申请”，是因为它们基本上不需要临床前资料（动物实验）和临床资料（人体实验）来建立安全性的有效性。Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). 仿制药申请者必须要科学地论述他们的产品是生物等效的（也就是，和原创药同样的性能表现）One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers. 科学家论证生物等效性的一种方法就是测定仿制药到达24￣36位健康志愿者血流中的时间。This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug. 这个实验给出
仿制药的吸收率（rate of absorption）或者生物利用度，因此仿制药就可以凭此与原创药进行比较。The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug. 仿制药必须和原创药在同样的时间内将同样量的活性成分传输到患者的血流。
Using bioequivalence as the basis for approving generic copies of drug products was established by the "Drug Price Competition and Patent Term Restoration Act of 1984," also known as the Waxman-Hatch Act. 把生物等效性作为批准仿制药的基础是根据1984年的"药品价格竞争和专利恢复法案,"，来确立的，该法案也被称之为维克斯曼－哈奇法案。This Act expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without conducting costly and duplicative clinical trials. 本法令通过允许FDA批准品牌药的仿制版本的上市而无需进行昂贵和重复性的临床试验来加快较便宜的仿制药的获得。At the same time, the brand-name companies can apply for up to five additional years longer patent protection for the new medicines they developed to make up for time lost while their products were going through FDA's approval process. 同时，品牌药厂家也可以为他们所开发的新药申请五年的专利保护延期以弥补他们产品在通过FDA批准过程所损失的时间。Brand-name drugs are subject to the same bioequivalence tests as generics upon reformulation. 品牌药在改变配方时也要进行和仿制药一样的生物等效性实验。For more information on generic drug bioequivalency requirements, please see the chapter entitled "FDA Ensures Equivalence of Generic Drugs" in "From Test Tube to Patient: Improving Health Through Human Drugs."关于仿制药生物等效性方面要求的更多信息，请参见"从试管到患者：通过药品提高健康."
The Office of Generic Drugs home page provides additional information to generic drug developers, including an interactive flowchart presentation of the ANDA review process, focusing on how CDER determines the safety and bioequivalence of generic drug products prior to approval for marketing. 仿制药办公室的主页为仿制药开发者提供了
更多的信息，包括一个互动性的ANDA评审过程流程图，重点在于CDER在批准仿制药上市前是如何确定其安全性和生物等效性的。Generic drug application reviewers focus on bioequivalence data, chemistry and microbiology data, requests for plant inspection, and drug labeling information.仿制药申请的的评审官着重于生物等效性资料，化学和生物资料，工厂检查的要求和药品标签信息等。
This web site is designed for individuals from pharmaceutical companies, government agencies, academic institutions, private organizations, or other organizations interested in bringing a generic drug to market. 本网址是为来自制药企业，政府机关，学术单位，私营组织或其它组织中对将仿制药带入市场感兴趣的个人而设计的。Each of the sections below contains information from CDER to assist you in the ANDA application process. 下面的每一个章节都包括了来自CDER的信息以为你在ANDA申请过程中提供帮助。Click on a link to go directly to a section.点击链接直接进入相应的章节。
Resources for ANDA Submissions
ANDA递交方面的资源
The following resources have been gathered to provide you with the legal requirements of an ANDA application, assistance from CDER to help you meet those requirements, and internal ANDA review principles, policies and procedures.
如下资源集中在一起为你提供了ANDA申请的法律要求，来自于CDER的支持以帮助你满足他们的要求，ANDA的内部评审原则，政策和程序。
Guidance Documents for ANDAs
ANDA方面的指导文件
Guidance documents represent the Agency's current thinking on a particular subject. 指导文件代表了FDA对某一主题的当前看法。These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products. 这些文件旨在为FDA评审人员和申请者/发起人(Sponsor)在申请的内容整理，评审/批准等方面提供指南，同时也为受管产品的设计，生产，制造和测试等方面提供指南。They also establish policies intended to achieve consistency in the Agency's regulatory approach and establish inspection and enforcement procedures. 他们也建立政策以获得FDA法规方法方面的一致性，并建立检查和执行程序。Because guidances are not regulations or laws, they are not enforceable, either through administrative actions or through the courts. 因为指南既不是法律也不是法规，因此它们无论是在通过行政执行还是通过法院都没有强制性。An alternative approach may be used if such an approach satisfies the requirements of the applicable statute, regulations, or both.如果另有办法可以满足适宜法令和/或法规的要求，则该办法也是可以使用的。For information on a specific guidance document, please contact the originating office. 关于某一指定指南的相关信息，请与发起办公室联系。
The FDA has numerous guidances that relate to ANDA content and format issues.
FDA有很多关于ANDA内容和格式问题的指南。Below is a list of some recent Guidances of interest. 如下为一些最近的相关指南的列表。See Drug Information Branch's Guidance Documents for a complete list of available guidances online and instructions on how to obtain them. 关于可在线获得指南的完整列表和如何获得它们的指导，请参见药品信息部指南文件。Most of these documents are in Adobe Acrobat format
这些文件大部分都是Adobe Acrobat 格式的
帮助制作ANDA的指导文件以如下分类集中列在CDER的指导文件索引网页上：?Generics 仿制药.
?Generics (Draft - Distributed for comment purposes only)仿制药（草案－仅供征求意见用).
o Procedural Draft: Applications Covered by Section 505(b)(2) (Issued 10/1999, Posted 12/7/1999). 程序草案：法令第505（b）(2)章节所涉及
的申请（1999年10月发行，1999年12月7日公告）This provision permits
FDA to rely, for approval of an NDA, on data not developed by the
applicant. 本规定允许FDA在批准NDA时，可以信赖不是由申请者所开发
的资料。
?Biopharmaceutics生物制药.
?Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations 口服剂型的生物利用度和生物等效性研究－基本考
虑. Optional Format: PDF(Issued 10/2000, Posted 10/27/2000). 可选格式：PDF（2000年10月发行，2000年10月27日公告）。This guidance should be useful for applicants planning to conduct bioavailability (BA) and bioequivalence (BE) studies during the IND period for an NDA, BE studies intended for
submission in an ANDA, and BE studies conducted in the postapproval period for certain changes in both NDAs and ANDAs. 本指南对于准备在NDA的IND阶段进行生物利用度和生物等效性研究，准备为ANDA申请进行生物等效性研究，准备为NDA和ANDA的某些申请的批准前阶段进行生物等效性研究的申请者是有帮助的。
?Drug Master Files药品主文件. A Drug Master File (DMF) is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and
storing of one or more human drugs. 药品主文件（DMF）是交至FDA的文件，可用于向FDA提供一个或多个人用药的储存，包装，处理和制造过程中所用设施，
工艺或物质等方面的详细机密信息。
?Required Specifications for FDA's IND, NDA, and ANDA Drug Master File Binders。FDA的IND，NDA和ANDA药品主文件装订的所需要规范?Guidance for Industry: Changes to an Approved NDA or ANDA工业指南：已批准NDA或ANDA的变更
?Refusal to Receive.
The mission of FDA is to enforce laws enacted by the U.S. Congress and regulations established by the Agency to protect the consumer's health, safety, and
pocketbook. FDA的使命是执行美国议会所制订的法律和FDA所建立的法规以保护消费者的健康，安全和财力。The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the U.S. With numerous amendments it is the most extensive law of its kind in the world. 联邦食品，药品和化妆品法令是美国基本的食品和药品法律，它有很多的增补，它是世界上同类法律中最广泛的。The law is intended to assure consumers that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, informative, and not deceptive.法律旨在向消费者确保食品是纯净和卫生，可安全食用，且是在卫生的条件下生产的；向消费者确保化妆品是安全的，且是用合适的组分生产而来的；和向消费者确保所有的标签和包装是可信，详实的，且不能有欺诈性。
Code of Federal Regulations (CFR)美国联邦法规
Code Of Federal Regulation s (CFR)联邦法规（CFR）. The final regulations published in the Federal Register (daily published record of proposed rules, final rules, meeting notices, etc.) are collected in the CFR在联邦公报（每天公布拟定的法规，最终法规，会议通告等）上公布的最终法规会被收录在CFR里。. The CFR is divided into 50 titles which represent broad areas subject to Federal regulations. 联邦法规被分成50个主题，这些主题代表了联邦法规所属的广泛领域。The FDA's portion of the CFR interprets the Federal Food, Drug and Cosmetic Act and related statutes. 联邦法规（CFR）的FDA
部分解释联邦食品，药品和化妆品法令和相关的法规。Section 21 of the CFR contains most of the regulations pertaining to food and drugs. 联邦法规（CFR）第21部分包括了绝大部分食品和药品的相关法规。The regulations document most actions of all drug sponsors that are required under Federal law. 这些法规收录了联邦法律所需的所有药品发起人的绝大部分措施。The following regulations apply to the ANDA process:如下这些法规适用于ANDA过程：
?21CFR Part 314 Applications for FDA Approval to Market a New Drug or and Antibiotic Drug新药或新抗生素药品FDA上市批准的申请
?21CFR Part 320 Bioavailability and Bioequivalence Requirements生物利用度和生物等效性的要求. For more information on retention samples, please see
Bioequivalence Study Retention Samples.关于留样的更多信息，请参见生物等效性研究留样
o Bioavailability and Bioequivalence Requirements; Abbreviated
Applications; Final Rule. [TXT] [PDF] (Issued and posted 12/19/2002) 生
物利用度和生物等效性要求；简略申请；最终法令[TXT] [PDF]（2002年
12月19日发行公布）。
?21CFR Part 310 New Drugs新药
MaPPs 政策和程序手册
CDER's Manual of Policies and Procedures (MaPPs)provide official instructions for internal practices and procedures followed by CDER staff to help standardize the drug review process and other activities, both internal and external. CDER的政策和程序手册(MaPPs)提供了CDER人员所遵循的内部规范和程序以帮助实现药品评审过程和其它内部和外部活动的标准化。MaPPs define external activities as well. MaPPs 政策和程序手册同样也定义了外部活动。All MAPPs are available for the public to review to get a better understanding of office policies, definitions, staff responsibilities and procedures. 公众可以获得所有的政策和程序手册（MaPPs）以更好的理解办公政策，定义，人员职责和程序。MaPP documents to help prepare ANDAs are listed together on CDER's Manual of Policies and Procedures webpage.帮助制作ANDA的政策和程序手册（MaPPs）集中列在CDER的政策和程序手册（MaPPs）网页上。
?Chapter 5200 - Generic Drugs仿制药
ANDA Forms and Electronic Submissions ANDA表格和电子申请?ANDA Checklist for Completeness and Acceptability ANDA的完整性和可接受性的核对表
人用新药/人用新抗生素的上市申请
?The CDER Office of Generic Drugs has developed a guidance document entitled Providing Regulatory Submissions in Electronic Format ?ANDAs[PDF version] (Issued 6/2002, Posted 6/27/2002) to assist applicants making regulatory
submissions in electronic format of abbreviated new drug applications. CDER所属的仿制药办公室已经制订了一份题为：以电子形式提交ANDA申请[PDF
version]（2002年6月发行，2002年6月27日公告）以帮助申请者进行ANDA 的电子格式递交。This guidance should be used in conjunction with the following guidances: 本指南需和如下这些指南结合起来使用：
o Guidance for Industry: Providing Regulatory Submissions in Electronic Format –General Considerations工业指南：以电子格式递交申请－基本考
虑事宜.
o Regulatory Submissions in Electronic Format; New Drug Applications 以电子格式递交申请：新药申请.
?For more information on electronic submissions, see Electronic Regulatory Submission and Review. 关于电子递交方面的更多信息，请参见电子格式递交及评审.
Related Topics相关主题
?Investigational New Drug Application 新药临床试验申请(IND). Provides resources to assist drug sponsors with submitting applications for approval to
begin new drug experiments on human subjects. 向药品试验委托者（Drug
sponsor）提供资源以帮助其递交开始新药的人体试验的批准申请
?New Drug Application 新药申请(NDA). Provides resources to assist drug sponsors with submitting applications for approval to market a new drug. 向药品试验委托者（Drug sponsor）提供资源以帮助其递交新药上市的批准申请
?Drug Application Regulatory Compliance药品申请的法规符合The approval process for new drug applications includes a review of the manufacturer's
compliance with Current Good Manufacturing Practice. This web page provides resources to help meet compliance. 新药申请的批准过程包括生产厂家现行GMP符合性的评审。
?Information for Clinical Investigators 临床研究员需知. Provides regulations and guidelines to scientists who design and run experiments (clinical trials) to test the safety and effectiveness of new drugs on human subjects. 为设计和进行实验（临床试验）以检测新药对人体的安全性和有效性的科学家提供法规和指导。?Small Business Assistance Program小型事务支持程序.
?Electronic Regulatory Submission and Review 电子递交和评审
(ERSR). Provides information on electronic drug applications, application
reviews, Electronic Document Room, and other ERSR projects. 提供电子药品申请，申请评审，电子文件室和其它ERSR项目方面的信息。
?Post Drug-Approval Activities药品批准后活动. The goal of CDER's post drug-approval activities is to monitor the ongoing safety of marketed drugs. CDER 药品批准后活动的目的是监测已上市药品的安全性。This is accomplished by
reassessing drug risks based on new data learned after the drug is marketed, and recommending ways of trying to most appropriately manage that risk. 这一点是通过以药品上市后所获知的新资料为基础重新评药品风险，并建议能最适宜地管理该风险的方式来实现的。
德信诚培训网 更多免费资料下载请进：https://www.doczj.com/doc/1c16039107.html, 好好学习社区 Document Control Procedure 文件管理程序 1.0 Purpose 目的 Define the requirements and responsibilities for Document control. 定义出文件控制的要求和权责。 2.0 Scope 范围 This procedure applies to all QMS documentation, including: quality manual, procedure, WI, external document and form. 适用于与质量管理体系有关的所有文件。包括:手册、程序文件、操作指导书、外来文件及表单。 3.0 Definitions 定义 3.1 Quality Manual: According to the requirements of International and national standard (such as ISO9001), describe quality management system documentation in Co-active. 3.1质量手册：根据相关国际或国家标准(如ISO9001)要求，阐述本公司质量管理体系的文件。 3.2 Procedure: Define the function of QMS requirement allocation by department. Such as document control, management review, internal audit procedure. 3.2程序文件：描述为实施质量管理体系要求所涉及的各职能部门的活动的文件。如文件控制程序、 管理评审控制程序、内部审核控制程序。 3.3 Working Instruction: Operation procedures, inspection standards, design drawing and etc. 3.3操作指导书：操作规程、检验标准、加工图纸等。 3.4 Form: Records of operation results. 3.4表单：用于记录作业结果所用的文件。 4.0 Procedure 程序 4.1 Responsible for the formulation of documents to file the proper approval, and timely send the electronic document and the paper version to DCC, ensure that the relevant departments to understand the change. Once the document released, the relevant departments must follow procedures. When the file changes do not affect the contents of the file (such as correcting typos,
美国州名美国州名英文州名简写和简称首府首府英文名阿拉巴马州Alabama AL 蒙哥马利Montgomery 阿拉斯加州Alaska AK 朱诺Juneau 阿利桑那州Arizona AZ 菲尼克斯Phoenix 阿肯色州Arkansas AR 小石城Little rock 加利福尼亚州California CA 萨克拉门托Sacramento 科罗拉多州Colorado CO 丹佛Denver 康涅狄格州Connecticut CT 哈特福德Hartford 特拉华州Delaware DE 多佛Dover 佛罗里达州Florida FL 塔拉哈西Tallahassee 乔治亚州Georgia GA 亚特兰大Atlanta 夏威夷州Hawaii HI 檀香山火努鲁鲁Honolulu 爱达荷州Idaho ID 博伊西Boise 伊利诺斯州Illinois IL 斯普林菲尔德Springfield 印第安纳州Indiana IN 印第安纳波利斯Indianapolis 爱荷华州Iowa IA 得梅因Des Moines 堪萨斯州Kansas KS 托皮卡Topeka 肯塔基州Kentucky KY 法兰克福Frankfort 路易斯安那州Louisiana LA 巴吞鲁日Baton Rouge 缅因州Maine ME 奥古斯塔Augusta 马里兰州Maryland MD 安纳波利斯Annapolis 马萨诸塞州Massachusetts MA 波士顿Boston 密歇根州Michigan MI 兰辛Lansing 明尼苏达州Minnesota MN 圣保罗St. Paul 密西西比州Mississippi MS 杰克逊Jackson 密苏里州Missouri MO 杰斐逊城Jefferson City 蒙大拿州Montana MT 海伦娜Helena 内布拉斯加州Nebraska NE 林肯Lincoln 内华达州Nevada NV 卡森城Carson City 新罕布什尔州 New hampshire NH 康科德Concord 新泽西州New jersey NJ 特伦顿Trenton 新墨西哥州New mexico NM 圣菲Santa Fe 纽约州New York NY 奥尔巴尼Albany 北卡罗来纳州North Carolina NC 纳罗利Raleigh 北达科他州North Dakota ND 俾斯麦Bismarck 俄亥俄州Ohio OH 哥伦布Columbus 俄克拉荷马州Oklahoma OK 俄克拉何马城Oklahoma City 俄勒冈州Oregon OR 塞勒姆Salem 宾夕法尼亚州Pennsylvania PA 哈里斯堡Harrisburg 罗得岛州Rhode island RL 普罗维登斯Providence
美国五十州名称 州名英文音标简州名英文音标简亚拉巴马州Alabama [,?l?'b?m?] AL 阿拉斯加州Alaska [?'l?sk?]AK 亚利桑那州Arizona [,?ri'z?un?] AZ 阿肯色州Arkansas ['ɑ:k?ns?:]AR 加利福尼亚州California [,k?li'f?:nj?] CA 科罗拉多州Colorado [,k?l?'rɑ:d?u]CO 康涅狄格州Connecticut [k?'netik?t] CT 特拉华州Delaware ['del?w??]DE 佛罗里达州Florida ['fl?rid?] FL 佐治亚州Georgia ['d??:d?j?]GA 夏威夷州Hawaii [h?'waii:] HI 爱达荷州Idaho ['aid?h?u]ID 伊利诺伊州Illinois [,ili'n?i(z)] IL 印第安纳州Indiana [,indi'?n?]IN 艾奥瓦州Iowa ['ai?w?] IA 堪萨斯州Kansas ['k?nz?s]KS 肯塔基州Kentucky [ken't?ki] KY 路易斯安那Louisiana [lu:,i:zi'?n?]LA 缅因州Maine [mein] ME 马里兰州Maryland ['mε?ril?nd]MD 马萨诸塞州Massachusetts [,m?s?'t?u:sits] MA 密歇根州Michigan ['mi?ig?n]MI 明尼苏达州Minnesota [,mini's?ut?] MN 密西西比州Mississippi [,misi’sipi]MA 密苏里州Missouri [mi'zu?ri] MO 蒙大拿州Montana [m?n't?n?]MT 内布拉斯加州Nebraska [ni'br?sk?] NE 内华达州Nevada [ni'v?d?]NV 新罕布什尔州New Hampshire [nju: 'h?mp??] NH 新泽西州New jersey [nju: 'd??:zi]NJ 新墨西哥州New Mexico [nju: 'meksik?u] NM 纽约州New York [nju:j?:k]NY 北卡罗来纳州North Carolina [n?:θ ,k?r?'lain?] NC 北达科他州North Dakota [n?:θ d?'k?ut?]ND 俄亥俄州Ohio [?u'hai?u] OH 俄克拉何马Oklahoma [?ukl?'h?um?]OK 俄勒冈州Oregon ['?riɡ?n]OR 宾夕法尼亚Pennsylvana [pensil'veinj?] PA 罗得岛州Rhode Island [r?ud,'ail?nd] RL 南卡罗来纳州South Carolina [sauθ ,k?r?'lain?]SC 南达科他州South Dakota [sauθ d?'k?ut?] SD 田纳西州Tennessee [,teni'si:]TN 德克萨斯州Texas ['teks?s] TX 犹他州Utah ['ju:ta:]UT 佛蒙特州Vermont [v?:'m?nt] VT 弗吉尼亚州Virginia [v?(:)'d?inj?]VA 华盛顿州Washington ['w??i?t?n] WA 西弗吉尼亚州West Virginia [west v?(:)'d?inj?]WV 威斯康星州Wisconsin [wis'k?nsin] WI 怀俄明州Wyoming [wai'?umi?]WY 华盛顿特区Washington D.C. ['w??i?t?n di ci]
一、File<文件> 1.New<新建> 2.Open<打开> 3.Open As<打开为> 4.Open Recent<最近打开文件> 5.Close<关闭> 6.Save<存储> 7.Save As<存储为> 8.Save for Web<存储为Web所用格式> 9.Revert<恢复> 10.Place<置入> 11.Import<输入> <1>PDF Image <2>Annotations<注释> 页脚内容1
12.Export<输出> 13.Manage Workflow<管理工作流程> <1>Check In<登记> <2>Undo Check Out<还原注销> <3>Upload To Server<上载到服务器> <4>Add To Workflow<添加到工作流程> <5>Open From Workflow<从工作流程打开> 14.Automate<自动> <1>Batch<批处理> <2>Create Droplet<创建快捷批处理> <3>Conditional Mode Change<条件模式更改> <4>Contact Sheet<联系表> <5>Fix Image<限制图像> <6>Multi <多页面pdf到psd> <7>Picture package<图片包> 页脚内容2
<8>Web Photo Gallery 15.File Info<文件简介> 16.Print Options<打印选项> 17.Page Setup<页面设置> 18.Print<打印> 19.Jump to<跳转到> 20.Exit<退出> 二、Edit<编辑> 1.Undo<还原> 2.Step Forward<向前> 3.Step Backward<返回> 4.Fade<消退> 5.Cut<剪切> 6.Copy<拷贝> 页脚内容3
美国50州中英文名称对照表 Alabama 阿拉巴马（AL）* Alaska 阿拉斯加（AK）Arizona 亚利桑那（AZ）Arkansas 阿肯色（AR）California 加利福尼亚（CA）Colorado 科罗拉多（CO）Connecticut 康乃狄格（CT）Delaware 特拉华（DE）Florida 佛罗里达（FL）Georgia 佐治亚（GA）Hawaii 夏威夷（HI）Idaho 爱达荷（ID）Illinois 伊利诺斯（IL）Indiana 印第安纳（IN）Iowa 衣阿华（IA）Kansas 堪萨斯（KS）Kentucky 肯塔基（KY）Louisiana 路易西安那（LA）Maine 缅因（ME）Maryland 马里兰（MD）Massachusetts 马萨诸塞（MA）Michigan 密西根（MI）Minnesota 明尼苏达（MN）Mississippi 密西西比（MS）Missouri 密苏里（MO）Montana 蒙大拿（MT）Nebraska 内布拉斯加（NE）Nevada 内华达（NV）New Hampshire 新罕布什尔（NH）New Jersey 新泽西（NJ）New Mexico 新墨西哥（NM）New York 纽约（NY）North Carolina 北卡罗来纳（NC）North Dakota 北达科他（ND）Ohio 俄亥俄（OH）Oklahoma 俄克拉荷马（OK）Oregon 俄勒冈（OR）Pennsylvania 宾夕法尼亚（PA）Rhode Island 罗德岛（RI）South Carolina 南卡罗来纳（SC）South Dakota 南达科他（SD）Tennessee 田纳西（TN）
一、File 文件 1.New 新建 2.Open 打开 3.Open As 打开为 4.Open Recent 最近打开文件 5.Close 关闭 6.Save 存储 7.Save As 存储为 8.Save for Web存储为Web所用格式 9.Revert 恢复 10.Place 置入 11.Import 输入 1 PDF Image PDF图象导入 2 Annotations 注释 12.Export 输出 13.Manage Workflow 管理工作流程 1 Check In 登记 2 Undo Check Out 还原注销 3 Upload To Server 上载到服务器 4 Add To Workflow 添加到工作流程 5 Open From Workflow 从工作流程打开 14.Automate 自动 1 Batch 批处理 2 Create Droplet 创建快捷批处理 3 Conditional Mode Change 条件模式更改 4 Contact Sheet 联系表 5 Fix Image 限制图像 6 Multi Page PDF to PSD 多页面PDF文件到PSD文件 7 Picture package 图片包 8 Web Photo GalleryWeb照片画廊 15.File Info 文件简介 16.Print Options 打印选项 17.Page Setup 页面设置 18.Print 打印 19.Jump to 跳转到 20.Exit 退出 二、Edit 编辑 1.Undo 还原 2.Step Forward 向前 3.Step Backward 返回 4.Fade 消退 5.Cut 剪切 6.Copy 拷贝 7.Copy Merged 合并拷贝 8.Paste 粘贴 9.Paste Into 粘贴入 10.Clear 清除 11.Fill 填充 12.Stroke 描边 13.Free Transform 自由变形 14.Transform 变换 1 Again 再次 2 Sacle 缩放 3 Rotate 旋转 4 Skew 斜切 5 Distort 扭曲 6 Prespective 透视 7 Rotate 180°旋转180度 8 Rotate 90°CW 顺时针旋转90 9 Rotate 90°CCW 逆时旋转90 10 Flip Hpeizontal 水平翻转 11 Flip Vertical 垂直翻转 15.Define Brush 定义画笔 16.Define Pattern 设置图案 17.Define Custom Shape 定义自定形 状 18.Purge 清除内存数据 1 Undo 还原 2 Clipboard 剪贴板 3 Histories 历史纪录 4 All 全部 19.Color Settings 颜色设置 20.Preset Manager 预置管理器 21.Preferences 预设 1 General 常规 2 Saving Files 存储文件 3 Display ＆Cursors 显示与光标 4 Transparency ＆Gamut 透明区 域与色域 5 Units ＆Rulers 单位与标尺 6 Guides ＆Grid 参考线与网格 7 Plug Ins ＆Scratch Disks 增效工 具与暂存盘 8 Memory ＆Image Cache 内存和 图像高速缓存 9 Adobe Online Adobe在线 10 Workflows Options 工作流程选 项 三、Image 图像 1.Mode 模式 1 Bitmap 位图 2 Grayscale 灰度 3 Duotone 双色调 4 Indexed Color 索引色 5 RGB Color RGB色 6 CMYK Color CMYK色 7 Lab Color Lab色 8 Multichannel 多通道 9 8 Bits/Channel 8位通道 10 16 Bits/Channel 16位通道 11 Color Table 颜色表 12 AssingProfile 制定配置文件 13 Convert to Profile 转换为配置文 件 2.Adjust 调整 1 Levels 色阶 2 Auto Laves 自动色阶 3 Auto Contrast 自动对比度 4 Curves 曲线 5 Color Balance 色彩平衡 6 Brightness/Contrast亮度/对比度 7 Hue/Saturation 色相/饱和度 8 Desaturate 去色 9 Replace Color 替换颜色 10 Selective Color 可选颜色 11 Channel Mixer 通道混合器 12 Gradient Map 渐变映射 13 Invert 反相 14 Equalize 色彩均化 15 Threshold 阈值 16 Posterize 色调分离 17 Variations 变化
美国州名美国州名英文州名简写和简称首府首府英文名 阿拉巴马州Alabama AL 蒙哥马利Montgomery 阿拉斯加州Alaska AK 朱诺Juneau 阿利桑那州Arizona AZ 菲尼克斯Phoenix 阿肯色州Arkansas AR 小石城Little rock 加利福尼亚州California CA 萨克拉门托Sacramento 科罗拉多州Colorado CO 丹佛Denver 康涅狄格州Connecticut CT 哈特福德Hartford 特拉华州Delaware DE 多佛Dover 佛罗里达州Florida FL 塔拉哈西Tallahassee 乔治亚州Georgia GA 亚特兰大Atlanta 夏威夷州Hawaii HI 檀香山火努鲁鲁Honolulu 爱达荷州Idaho ID 博伊西Boise 伊利诺斯州Illinois IL 斯普林菲尔德Springfield 印第安纳州Indiana IN 印第安纳波利斯Indianapolis 爱荷华州Iowa IA 得梅因Des Moines 堪萨斯州Kansas KS 托皮卡Topeka 肯塔基州Kentucky KY 法兰克福Frankfort 路易斯安那州Louisiana LA 巴吞鲁日Baton Rouge 缅因州Maine ME 奥古斯塔Augusta 马里兰州Maryland MD 安纳波利斯Annapolis 马萨诸塞州Massachusetts MA 波士顿Boston 密歇根州Michigan MI 兰辛Lansing 明尼苏达州Minnesota MN 圣保罗St. Paul 密西西比州Mississippi MS 杰克逊Jackson 密苏里州Missouri MO 杰斐逊城Jefferson City 蒙大拿州Montana MT 海伦娜Helena 内布拉斯加州Nebraska NE 林肯Lincoln 内华达州Nevada NV 卡森城Carson City 新罕布什尔州 New hampshire NH 康科德Concord 新泽西州New jersey NJ 特伦顿Trenton 新墨西哥州New mexico NM 圣菲Santa Fe 纽约州New York NY 奥尔巴尼Albany 北卡罗来纳州North Carolina NC 纳罗利Raleigh 北达科他州North Dakota ND 俾斯麦Bismarck 俄亥俄州Ohio OH 哥伦布Columbus 俄克拉荷马州Oklahoma OK 俄克拉何马城Oklahoma City 俄勒冈州Oregon OR 塞勒姆Salem ;.
CONFIDENT IAL IT Y PROCEDURE 10 DECEMBER 2010
SYNOPSIS
CONTENTS CONTENTS (3) 1.PURPOSE 目的 (4) 2.RESPONSIBILITYS 职责 (5) 3.CONFIDENTIAL INFORMATION SCOPE (6) 4.STORAGE，COPY, DISTRIBUTION, BORROW AND DISPOSAL (7) 4.1Storage and Copy (7) 4.2Distribution (7) 4.3Disposal (8) APPENDIX 1– CONFIDENTIAL DOCUMENT DISTRIBUTION REGISTER APPENDIX 2– CONFIDENTIAL DOCUMENT CHECKLIST
1. PURPOSE 目的 This procedure provides the necessary requirements and guidelines for controlling confidential documents to assure XX COMPANY personnel are aware of storage, copy, distribution, and disposal confidential documentation. 本程序旨在提供了一些必要的要求和准则，用于控制保密级别的文件以确保XX公司员工明确保密文件的存储，复印，发布和销毁的程序。
2. RESPONSIB IL IT YS职责 XX Manager is responsible for the implementation of this procedure in order to protect the company and client intellectual property information. 为了更好的对公司和业主的知识产权进行保护XX经理负责实施本程序。 Document Control has the administrative responsibility for implementing the procedure from the electronic file, hard copy distribution, and record keeping standpoint. 文档控制工程师根据本程序的要求负责管理电子档文件，硬拷贝文件的发布，以及记录和追踪。 XX company member should be required to comply Confidentiality Procedure. XX公司所有员工要求遵守本程序。
美国各州的中英文对照图： 美国共51个州加1个华盛顿特区，分5个不同的时区： 一、阿拉斯加/夏威夷时区 与中国时差-17～-18小时（中国早晨9点，是这两个地区的前一天下午3～4点） 二、Pacific Time Zone太平洋时区 与中国时差-16小时（中国早晨9点，是美国太平洋时区内的州的前一天下午5点）包括：太平洋沿岸州即：WA/OR/CA/NV/ID 三、Mountain Time Zone 山地时区 与中国时差-15小时（中国早晨9点，是美国该时区内的州的前一天下午6点） 包括：MT/WY/UT/CO/AZ/NM
四、Central Time Zone中央平原时区 与中国时差-14小时（中国早晨9点，是美国该时区内的州的前一天晚上7点） 包括：中央平原及南部和东南部地区：ND/SD/NE/KS/OK/TX/MN/IA/MO/AR/LA/WI/IL/MS 五、Eastern Time Zone东部时区 与中国时差-13小时（中国早晨9点，是美国该时区内的州的前一天晚上8点）包括：新英格兰地区、五大湖周边地区、中部及大西洋沿岸地区： ME/VT/NH/MA/CT/RI/NY/PA/MI/IN/OH/KY/WV/VA/NC/SC/GA/FL 美国各州的中英文对照表： 阿拉巴马Alabama AL 阿拉斯加Alaska AK 亚历桑那Arizona AZ 阿肯萨斯Arkansas AR 加利福尼亚California CA 柯罗拉多Colorado CO 康涅狄格Connecticut CT 德拉瓦Delware DE 佛罗里达Florida FL 乔治亚Georgia GA 夏威夷Hawaii HI 爱德华Idaho ID 伊利诺Illinois IL 印地安那Indiana IN 爱荷华Iowa IA 肯萨斯Kansas KS 肯塔基Kentucky KY 路易斯安那Louisiana LA 缅因Maine ME 马里兰Maryland MD 马萨诸塞Massachusetts MA 密西根Michigan MI 明尼苏达Minnesota MN 密西西比Mississippi MS 密苏里Missouri MO 蒙大纳Montana MT 内布拉斯加Nebraska NE 内华达Nevada NV 新罕布什尔New Hampshire NH 新泽西New Jersey NJ 新墨西哥New Mexico NM
1.Sales Agreement The agreement, (is) made in Beijing this eighth day of August 1993 by ABC Trading Co., Ltd., a Chinese Corporation having its registered office at Beijing, the People’ Repubic of China (hereinafter called “Seller”) and International Tradi ng Co., Ltd., a New York Corporation having its registered office at New York, N.Y., U.S.A. (hereinafter called “Buyer”). 2.WITNESSETH WHEREAS, Seller is engaged in dealing of (product) and desires to sell (product)to Buyer, and WHEREAS, Buyer desires to purchase(product) from Sellers, Now, THEREFORE, it is agreed as follows: 3.Export Contract This Contract is entered into this 5th day of August 1993 between ABC and Trading Co., Ltd. (hereinafter called “Seller”) who agrees to sell, and XYZ Trading Co., Ltd. (hereinafter called “Buyer”) who agrees to buy the following goods on the following terms and condition. 4.Non-Governmental Trading Agreement No. ＿＿This Agreement was made on the＿day of＿19＿, BETWEEN ＿ (hereinafter referred to as the Seller) as the one Side and ＿ (hereinafter referred to as the Buyer) as the one other Side. WHEREAS, the Seller has agreed to sell and the buyer has agreed to buy ＿ (hereinafter referred to as the Goods ) the quantity, specification, and price of which are provided in Schedule A. IT IS HEREBY AGREED AS FOLLOWS: 5.Contract For Joint-Operation Enterprise ＿＿ COMPANY LTD., a company duly organized under the Law of ＿＿ and having its registered office at (hereinafter called “Party A”) AND ＿＿ COMPANY LTD., a company duly organized under the Law of ＿＿ and having its registered office at (hereinafter called “Party B”) Party A and Party B (hereinafter referred to as the “Parties”) agree to jointly form a Co-operation Venture Company (hereinafter referred to as the “CVC”) in accordance with “the Laws of the People’s Republic of China on Joint Ventures Using Chinese and Foreign Investment” and the “Regulations for the Implementation of the Laws of the People’s Republic of China on Joint Ventures Using Chinese and Foreign Investment” and other applicable laws and regulations. 6.MODEL CONTRACT Contract No. Date: Seller: Signed at: Address: Cable Address: Buyer: Address: Cable Address: The Seller and the Buyer have agreed to conclude the following transactions according to the terms and conditions stipulated below: https://www.doczj.com/doc/1c16039107.html, of Commodity: 2.Specifications: 3.Quantity: 4.Unit Price: 5.Total Price: U.S.$: 6.Packing: 7.Time of Shipment: days after receipt of L/C. 8.Loading Port & Destination Port: From via to . 9.Insurance:
美国州名 欧阳光明 （2021.03.07） 美国州名英文 州名简写和简 称 首府首府英文名 阿拉巴马州Alabama AL 蒙哥马利Montgomery 阿拉斯加州Alaska AK 朱诺Juneau 阿利桑那州Arizona AZ 菲尼克斯Phoenix 阿肯色州Arkansas AR 小石城Little rock 加利福尼亚 州 California CA 萨克拉门托Sacramento 科罗拉多州Colorado CO 丹佛Denver 康涅狄格州Connecticut CT 哈特福德Hartford 特拉华州Delaware DE 多佛Dover 佛罗里达州Florida FL 塔拉哈西Tallahassee 乔治亚州Georgia GA 亚特兰大Atlanta 夏威夷州Hawaii HI 檀香山火努鲁 鲁 Honolulu 爱达荷州Idaho ID 博伊西Boise 伊利诺斯州Illinois IL 斯普林菲尔德Springfield 印第安纳州Indiana IN 印第安纳波利斯Indianapolis 爱荷华州Iowa IA 得梅因Des Moines 堪萨斯州Kansas KS 托皮卡Topeka 肯塔基州Kentucky KY 法兰克福Frankfort 路易斯安那 州 Louisiana LA 巴吞鲁日Baton Rouge 缅因州Maine ME 奥古斯塔Augusta 马里兰州Maryland MD 安纳波利斯Annapolis 马萨诸塞州Massachusetts MA 波士顿Boston 密歇根州Michigan MI 兰辛Lansing 明尼苏达州Minnesota MN 圣保罗St. Paul 密西西比州Mississippi MS 杰克逊Jackson 密苏里州Missouri MO 杰斐逊城Jefferson City 蒙大拿州Montana MT 海伦娜Helena 内布拉斯加 州 Nebraska NE 林肯Lincoln 内华达州Nevada NV 卡森城Carson City 新罕布什尔 州 New hampshire NH 康科德Concord 新泽西州New jersey NJ 特伦顿Trenton 新墨西哥州New mexico NM 圣菲Santa Fe 纽约州New York NY 奥尔巴尼Albany 北卡罗来纳 州 North Carolina NC 纳罗利Raleigh 北达科他州North Dakota ND 俾斯麦Bismarck 俄亥俄州Ohio OH 哥伦布Columbus
5S : 5S 管理 ABC : 作业制成本制度(Activity-Based Costing) ABB : 实施作业制预算制度(Activity-Based Budgeting) ABM : 作业制成本管理(Activity-Base Management) APS : 先进规画与排程系统(Advanced Planning and Scheduling) ASP : 应用程序服务供货商（Application Service Provider） ATP : 可承诺量(Available To Promise) A VL : 认可的供货商清单(Approved Vendor List) BOM : 物料清单(Bill Of Material) BPR : 企业流程再造(Business Process Reengineering) BSC : 平衡记分卡(Balanced ScoreCard) BTF : 计划生产(Build To Forecast) BTO : 订单生产(Build To Order) CPM : 要径法(Critical Path Method) CPM : 每一百万个使用者会有几次抱怨(Complaint per Million) CRM : 客户关系管理(Customer Relationship Management) CRP : 产能需求规划(Capacity Requirements Planning) CTO : 客制化生产(Configuration To Order) DBR : 限制驱导式排程法(Drum-Buffer-Rope) DMT : 成熟度验证(Design Maturing Testing) DVT : 设计验证(Design Verification Testing) DRP : 运销资源计划(Distribution Resource Planning) DSS : 决策支持系统(Decision Support System) 返回顶部 EC : 设计变更／工程变更(Engineer Change) EC : 电子商务(Electronic Commerce) ECRN: 原件规格更改通知(Engineer Change Request Notice) EDI : 电子资料交换(Electronic Data Interchange) EIS : 主管决策系统(Executive Information System) EMC : 电磁兼容(Electric Magnetic Capability) EOQ : 基本经济订购量(Economic Order Quantity) ERP : 企业资源规划(Enterprise Resource Planning) FAE : 应用工程师(Field Application Engineer) FCST: 预估(Forecast) FMS : 弹性制造系统(Flexible Manufacture System) FQC : 成品品质管制(Finish or Final Quality Control) IPQC: 制程品质管制(In-Process Quality Control) IQC : 进料品质管制(Incoming Quality Control) ISO : 国际标准组织(International Organization for Standardization) ISAR: 首批样品认可(Initial Sample Approval Request) JIT : 实时管理(Just In Time) KM : 知识管理(Knowledge Management) 返回顶部 L4L : 逐批订购法(Lot-for-Lot)
Constitution of the United States 美国宪法中英文版 导言 We, the people of the United States, in order to form a more perfect Union, establish justice, insure domestic tranquility, provide for the common defense, promote the general welfare, and secure the blessings of liberty to ourselves and our posterity, do ordain and establish this Constitution for the United States of America. 序言 我们美利坚合众国的人民，为了组织一个更完善的联邦，树立正义，保障国内的安宁，建立共同的国防，增进全民福利和确保我们自己及我们后代能安享自由带来的幸福，乃为美利坚合众国制定和确立这一部宪法。 Section 1 - Legislative powers; in whom vested All legislative powers herein granted shall be vested in a Congress of the United States, which shall consist of a Senate and House of Representatives. 第一条 第一款本宪法所规定的立法权，全属合众国的国会，国会由一个参议院和一个众议院组成。 Section 2- House of Representatives, how and by whom chosen Qualifications of a Representative. Representatives and direct taxes, how apportioned. Enumeration. Vacancies to be filled. Power of choosing officers, and of impeachment. 1. The House of Representatives shall be composed of members chosen every second year by the people of the several States, and the elector in each State shall have the qualifications requisite for electors of the most numerous branch of the State Legislature. 众议院应由各州人民每两年选举一次之议员组成，各州选举人应具有该州州议会中人数最多之一院的选举人所需之资格。 2. Representatives and direct taxes shall be apportioned among the several States which may be included within this Union, according to their respective numbers, which shall be determined by adding the whole number of free persons, including those bound to service for a term of years, and excluding Indians not taxed, three-fifths of all other persons.(The previous sentence was superceded by Amendment XIV，前面语句已由宪法修正案XIV替代). The actual enumeration shall be made within three years after the first meeting of the Congress of the United States, and within every subsequent term of ten years, in such manner as they shall by law direct. The number of Representatives shall not exceed one for every thirty thousand, but each State shall have at least one Representative; and until such enumeration shall be made, the State of New Hampshire shall be entitled to choose three, Massachusetts eight, Rhode Island and Providence Plantations one, Connecticut five, New York six, New Jersey four, Pennsylvania eight, Delaware one, Maryland six, Virginia ten, North Carolina five, South Carolina five, and Georgia three. 众议员人数及直接税税额，应按联邦所辖各州的人口数目比例分配，此项人口数目的计