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201409 FDA技术标准文件：PDF标准要求（中英文）PORTABLE DOCUMENT FORMAT (PDF) 便携式文档格式（PDF） SPECIFICATIONS 标准要求 Technical Specifications Document 技术标准文件 This Document is incorporated by reference into the following Guidance Document(s): 本文件制订中参考了以下指南文件： Guidance for Industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications 行业指南：以电子格式提交法规申报资料---使用eCTD规格制作的特定人药申报和相关申报 For questions regarding this technical specifications document, contact CDER at esub@fda.hhs.gov or CBER at esubprep@fda.hhs.gov U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) September 2014
Revision History 修订历史 Revision History Date | | | | | | | | | | | | | | Changed “Bookmarks and Page” to “Bookmarks Panel and Page” in Open Dialog Box section | | | 将开放对话框部分的“书签和页码”改为“书签面板和页码”。 | | | Updated to align with ICH recommendation on PDF version 1.7; add “Purpose” section; clarify specifications related to security, usability, and promotional materials; revise list of standard fonts; add PDF optimization; and incorporate editorial changes | | | 更新以与ICH建议的PDF第1.7版保持一致；增加“目的”部分；澄清与安全、可用性和宣传材料有关的规格标准；修订标准字体清单；增加PDF优化以及编辑性修改。 | | | Clarified language on acceptable PDF versions for documents; added page numbers | | | | | | Updated to align with ICH recommendation on PDF/A; clarify embedding of fonts and font size in embedded images; revise specifications related to document naviagation; and indicate maximum allowable PDF file size | | | 更新以与ICH对PDF/A的建议；澄清嵌入图片中嵌入字体大小；修订与文件导航有关的标准要求，以及说明允许的最大PDF文件大小。 |
Table of Contents 目录 PURPOSE | | | | | | | | | | | | SOURCE OF ELECTRONIC DOCUMENTS | | METHODS FOR CREATING PDF DOCUMENTS AND IMAGES | | IMAGE COMPRESSION TO REDUCE FILE SIZE | | OPTIMIZE FOR FAST WEB VIEW | | | | | | | | | | | | | | SPECIAL CONSIDERATIONS FOR PROMOTIONAL MATERIAL | |
PORTABLE DOCUMENT FORMAT (PDF) SPECIFICATIONS 便携式文件格式（PDF）标准要求 PURPOSE 目的 These specifications are for creating documents in Portable Document Format (PDF) for submission to CDER or CBER, that align with ICH M2 recommendation[1] and that are in a format that the receiving Center currently supports. For purposes of this document, “supports” means the receiving Center has established processes and technology infrastructure to support the receipt, processing, review and archive of files in the specified standard format. PDF is an open, published format created by Adobe Systems Incorporated (http://www.adobe.com). Software from a variety of sources can be used to create files in the PDF format. 这些质量标准是为提交给CDER或CBER的PDF申报文件创建而制订的，它与ICH M2建议一致，所用格式是接收中心目前所支持的。在此文件中，“支持”意为接收中心已建立了流程和技术框架来支持指定标准格式文件的接收、处理、审核和归档。PDF是由Adobe Systems Incorporated (http://www.adobe.com)创建的一种开放的、公开的格式。来自不同来源的软件都可以用于创建PDF格式文件。 VERSION 版本 PDF versions 1.4 through 1.7, PDF/A-1 and PDF/A-2 are acceptable for documents. Submitted PDF files should be readable by Adobe Acrobat X, should not require additional software or plug-ins to be read and navigated, and should be text searchable. If plug-ins are used during the creation of a PDF document, prior to submitting the document, ensure that a plug-in is not needed for review or archive. PDF版本1.4到1.7、PDF/A-1和PDF/A-2都是可接受的。提交的PDF文件应可以采用Adobe Acrobat X读出，不应需要其它软件或插件来阅读和导航，应该可以搜索文本。如果在创建PDF文件时使用了插件，在提交文件之前，要确保审核或归档时不需要使用插件。 PDF files must not contain JavaScript; dynamic content which can include audio, video or special effects and animations; attachments or 3D content. Do not include PDF annotations in documents. Ensure that all hypertext links in documents remain active after conversion to PDF/A. PDF文件不得包括在JavaScript、包括视频、音频或特殊效果和动画的动态内容、附件或3D内容。不要在文件中包括PDF注释。确保文件里所有超文件链接在转换成PDF/A后仍保持激活。 SECURITY 安全 Do not activate security settings or password protection. The integrity of the submitted files is maintained through Agency security and archival processes. A copy of the files, generated from the submitted files, will be provided to the reviewer. The reviewer should be able to print, select text and graphics, and make changes to text, notes and form fields using the provided copy. 不要激活安全设置或密码保护。所提交文件的完整性是通过机构的安全和存档处理来维护的。从所提交文件中生成的文件的一份副本会提交给审核人员。审核人员可以使用所提供的副本进行打印、选择文本和图形、对文件、标注和表格域进行修改。 FDA Forms downloaded from the FDA Forms website contain security settings that prevent changing the documents. These forms should be submitted as provided, with no additional security added and without removing the provided security settings. 从FDA表格网页上下载的FDA表格包括了安全设置，防止文件被修改。这些表格应按所提供的形式提交，不要增加额外的安全，不要移除所提供的安全设置。 FONTS 字体 Fully embed all non-standard fonts. PDF viewing software automatically substitutes a font to display text if the font used to create the text is unavailable on the reviewer’s computer. In some cases, font substitution can occur even when the fonts are available. For example, Helvetica or Times are substituted even if available on the reviewer’s computer. Font substitution can affect a document’s appearance and structure, and in some cases it can affect the information conveyed by a document. 将所有非标准字体完全嵌入。如果用于创建文本的字体在审核人员的电脑上没有，PDF浏览软件会自动替换字体来显示文本。在有些情形下，即使其电脑上有该字体，也可能会发生替换。例如，即使审核人员电脑上有，Helvetica或Times字体也会被替换。字体替换可能会影响文件的显示和结构，在有些情形下它可能会影响文件所要传达的信息。 Font availability to the reviewer is ensured if all non-standard fonts are fully embedded. When fonts are embedded, all characters for the font should be included not just a subset of the fonts being used in the document. Inspect documents to make sure all non-standard fonts are fully embedded prior to submission. 如果所有非标准字体被全部嵌入，则能保证审核人可以获得该字体。如果字体被嵌入，应该包括该字体的所有字符，而不是仅仅嵌入文件中所使用的文字。检查文件确认所有非标准字体在提交申报之前完全嵌入。 Font embedding does not always solve the problems that occur when a reviewer tries to copy and paste text from a PDF document into another software format. If the font is not available on the reviewer’s computer, font substitution results, even if the fonts are embedded. This problem is avoided if the fonts are restricted to the standard fonts listed in Table 1. 字体嵌入并不总能解决当审核人员试图复制PDF文件中的文本粘贴至另一软件格式时发生的问题。如果审核人员的电脑上没有该字体，即使字体已被嵌入，还是可能会发生字体替换。如果所用字体只限于表1中所列的标准字体，则可以避免此问题。 译者注：字体嵌入有部分嵌入和完全嵌入两种，部分嵌入是将文件中所用到的字符嵌入，完全嵌入则是将该字体的全部字符嵌入。以下是操作方法： 1.打印－选Adobe PDF，然后点 属性 2. 在Adobe PDF设置中，点 “编辑”，会跳出个新窗口。 3. 在新窗口中，选“字体”，在嵌入所有字体前打勾，然后把 字体来源的所有字体都添加到“总是嵌入”，然后按确定，会把这个设定保持成一个名字（可默认也可以自己改名），回到Adobe PDF设置窗口。 4. 然后在默认设置的下拉框中选你刚才设置好的那个字体设置的名字，并且把“不要发送字体到Adobe PDF“前的勾去掉。按"ok"，然后按打印。 5.检查所有字体是否都已经嵌入。在打开的PDF文档中，文件－文档属性－字体，看是否所有字体名字的后面是否有“已嵌入子集”，如果都有，那说明所有字体已经嵌入，如果还有字体后面没有出现这些字眼，说明这些字体还未嵌入，要再想办法。 6. 如果是用Matlab画的eps图，会出现“Helvetica" 和“Times-Bold ” 字体未嵌入的情况，办法如下：用文本打开eps文件，出现的是图片的源代码，把里面的 “Helvetica”字体换成“ NimbusSanL-Regu”，把“Times-Bold“ 换成“TimesNewRomanPS-BoldMT” 即可。反正就是把这个文档里面不能嵌入的字体换成可以嵌入的字体，可以在刚才上面添加的字体库中去选个合适的字体来替换。 Table 1: List of Standard Fonts 表1：标准字体列表 Font type 字体类型 | | | | | | | | | Times New Roman Bold Italic | | | | | | | | | | | | | | | | | | | | |
Use font sizes ranging from 9 to 12 point. Times New Roman 12-point font is recommended for narrative text. When choosing a point size for tables, a balance should be made between providing sufficient information on a single page that may facilitate data comparisons while still achieving a point size that remains legible. Generally, point sizes 9-10 are recommended for tables; smaller point sizes should be avoided. Ten point fonts are recommended for footnotes. 使用可以从9号到12号。建议陈述文本使用12号新罗马体。在为表格选择字号时，应考虑尽量在单页中提供充分的信息以助于数据比较，但让字号大小仍能使得文字保持清晰可读。一般来说，表格建议使用9-10号字体，应避免使用更小的字号。脚注建议使用10号字。 When creating documents which include scanned images, ensure that any resizing of the image does not reduce the effective font size below the recommended size. 在创建包括扫描的图片的文件时，要确保调整图片尺寸不会将有效字体尺寸减少到建议的尺寸以下。 Black is the recommended font color except that blue can be used for hypertext links. Light colors do not print well on grayscale printers. Any colors used should be tested prior to submission by printing sample pages from the document using a grayscale printer. 字颜色建议采用黑色，除了超链接使用蓝色以外。淡色采用灰度打印时打印效果不好。在提交申报资料前，应对所用的所有颜色进行测试，采用灰度打印机从文件中打印样本页。 PAGE ORIENTATION 页面方向 Save the page orientation for proper viewing and printing within the document. Proper page orientation eliminates the need for reviewers to rotate pages. For example, setting page orientation of landscape pages to landscape prior to saving the PDF document in final form ensures a correct page presentation. 文件里页面方向应适合审核和打印。适当的页面方向可以避免审核人员旋转页面。例如，将横向页面设定纵向页面方向，再保存PDF文件，以确保页面显示正常。 PAGE SIZE AND MARGINS 页面尺寸和页边距 Set up the print area for pages to fit on a sheet of paper that is 8.5 inches by 11 inches. A margin of at least 3/4 of an inch on the left side of page avoids obscuring information when pages are subsequently printed and bound. Setting the margin for at least 3/8 of an inch on the other sides is sufficient. For pages in landscape orientation, a margin of 3/4 of an inch at the top allows more information to be displayed legibly on the page. Header and footer information should not invade the specified margins (i.e., header and footer information should not appear within 3/8 of an inch of the edge of the 8.5 by 11 inch page), so the text will not be lost upon printing or being bound. These margins allow printing on A4 as well. Oversized documents (e.g., CAD drawings or other specialized documents) and promotional materials submitted in PDF format should be created according to their actual page size. 设定页面的打印区域，以适应页边距为8.5英寸（21.59cm）和11英寸（27.94cm）。页边距为左3/4英寸（1.905mm），以避免在后期打印和装订时信息被挡住。其它边距应至少为3/8英寸（9.525mm）就可以了。对于横向页面，顶端边距应为3/4英寸，以使得页面上信息能够清晰显示。页眉和页脚信息不应占用指定的页边空白（即，页眉和页脚信息不应出现在8.5英寸X11英寸的边距3/4英寸内），这样文本不会在打印或装订时缺失。这些边距使得在A4页面上打印也可行。以PDF格式提交的超出尺寸的文件（例如，CAD绘图或其它专业文件）和宣传材料应根据其实际页面尺寸来创建。 译者注：美国所用标准纸Letter尺寸（21.59cmX27.94cm），中国所用标准纸为A系列。因此在制作美国注册文件时，应注意将文档纸张大小调整为Letter尺寸。 SOURCE OF ELECTRONIC DOCUMENTS 电子文件的来源 Avoid image-based PDF files whenever possible. PDF documents produced by scanning paper documents usually have poorer image resolution than PDF documents produced from electronic source documents such as word processing files. Scanned documents are generally more difficult to read and do not allow the reviewer to search or copy and paste text for editing in other documents. If scanned files must be submitted, they should be made text searchable where possible. If optical character recognition software is used, verify that imaged text is converted completely and accurately. 应尽可能避免来源于图片的PDF。采用扫描纸质文件来生成的PDF文件通常其分辨率比从电子来源的文件如WORD生成的文件要低。扫描出的文件通常更难以阅读，审核人员无法进行搜索或复制粘贴文件至其它文件进行编辑。如果必须提交扫描文件，则应尽可能制作成为文本可搜索的。如果使用了文字识别软件，则应核查图片方字已准确完全地进行了转化。 METHODS FOR CREATING PDF DOCUMENTS AND IMAGES 创建PDF文件和图片的方法 Use the dpi settings in Table 2 for scanning documents. Scanned documents scanned at a resolution of 300 dots per inch (dpi) ensure that the pages of the document are legible both on the computer screen and when printed and, at the same time, minimizes the file size. The use of grayscale and color significantly increases the file size and should be used only when these features improve the reviewability of the material. After scanning, avoid resampling to a lower resolution. A captured image should not be subjected to non-uniform scaling (i.e., sizing). See the following table for resolutions for various images. 扫描文件时要使用表2中的dpi分辨率设置。采用300dpi分辨率扫描出的文件能确保文件的页面在电脑屏幕上和打印出来时均清晰，同时能减少文件大小。使用灰度和彩色会大大增加文件尺寸，应该只有在改善资料可审核性的属性时才使用。在扫描后，要避免重新采样降低分辨率。捕获的图片不应进行不统一的裁剪（即，改变尺寸）。参见下表对不同图片的分辨率要求。 Table 2: Scanning Resolution 表2：扫描分辨率 Document type | | | | | | | | | | | | Photographs – black and white | 600 dpi (8 bit gray scale ) | | | | | | | | 600 dpi (8 bit grayscale depth) | | | High pressure liquid chromatography | | | |
IMAGE COMPRESSION TO REDUCE FILE SIZE 压缩图片以减少文件大小 Compress files using either Zip/Flate or CCITT Group 4. File compression is a method for reducing file size. Some methods of compression can result in loss of data and can introduce compression artifacts that affect the reviewability of the information. The following two methods provide lossless compression. 使用ZIP/FLATE或CCITT Group 4进行压缩。文件压缩是减少文件大小的方法。一些压缩方法可能会导致数据丢失，可能会减少压缩工作，影响信息的可审核程度。以下两种方法可以提供无缺失压缩。 ― Zip/Flate (one technique with two names) for lossless compression of color and grayscale images is specified in Internet RFC 1950 and RFC 1951. ― ZIP/FLATE（同一技术的两个名称）是在网络RFC1950和RFC1951中指定的色彩和灰度图片无损压缩 ― CCITT Group 4 Fax compression technique recommendations for lossless compression of black and white images is specified in T.6 (1988) - Facsimile coding schemes and coding control functions for Group 4 facsimile apparatus. ― CCITT Group 4传真压缩技术建议是在T.6(1988)中指定的黑白图片无损压缩---Group 4传真设备传真代码组织和代码控制功能 OPTIMIZE FOR FAST WEB VIEW 为快速网页浏览所做的优化 Create files from source documents using the “Optimize the PDF for fast web view” option to reduce file sizes and file opening times. 从源文件使用“优化PDF以方便快速网页浏览”选项创建文件以减小文件大小和缩短文件打开时长。 IMAGE COLOR MATCHING 图片色谱匹配 Because color varies from monitor to monitor, it is difficult to ensure that the reviewer will see exactly the same color as in the actual image. However, for printing, there is more control over the color by using CMYK (Cyan, Magenta, Yellow, Black) color model as opposed to the RGB model. Pantone Matching using the color profile provided by CMYK ensure color consistency for printing. The International Color Consortium (ICC)[2] color profile specification is used when PDF documents are printed. 因为显示器的色彩显示会有差异，因此很难确保审核人员能看到与实际图形完全相同的色彩。但是，对于打印，需要使用CMYK（青红黄黑）四色模式来控制色彩，而不是RGB模式。彩通使用由CMYK提供的色彩谱系，确保打印色一致。在打印PDF文件时，使用的是国际色彩联盟（ICC）色彩谱系标准。 译者注：CMYK是印刷四分色模式，是彩色印刷时采用的一种套色模式，利用色料的三原色混色原理，加上黑色油墨，共计四种颜色混合叠加，形成所谓“全彩印刷”。四种标准颜色是： C：Cyan ＝ 青色，又称为‘天蓝色’或是‘湛蓝’ M：Magenta ＝ 品红色，又称为‘洋红色’ Y：Yellow ＝ 黄色 K：Key(blacK) ＝ 定位套版色（黑色） 三原色光模式（RGB color model），又称RGB颜色模型或红绿蓝颜色模型，是一种加色模型，将红（Red）、绿（Green）、蓝（Blue）三原色的色光以不同的比例相加，以产生多种多样的色光。 RGB颜色模型的主要目的是在电子系统中检测，表示和显示图像，比如电视和电脑，但是在传统摄影中也有应用。在电子时代之前，基于人类对颜色的感知，RGB颜色模型已经有了坚实的理论支撑。 RGB是一种依赖于设备的颜色空间：不同设备对特定RGB值的检测和重现都不一样，因为颜色物质（荧光剂或者染料）和它们对红、绿和蓝的单独响应水平随着制造商的不同而不同，甚至是同样的设备不同的时间也不同。 USE OF THUMBNAILS 使用缩略图 PDF documents do not need embedded thumbnails. PDF文件不需要嵌入缩略图。 DOCUMENT NAVIGATION 文件导航 A table of contents (TOC), hypertext links and bookmarks provide essential navigation through PDF documents. Include a hypertext linked TOC and bookmarks in documents 5 pages or longer. 目录（TOC）、超文件链接和书签提供对整个PDF文件的必要导航。如果文件达到或超过5页，应包括超文本链接TOC和书签。 Use hypertext links throughout the body of all documents to link to supporting annotations, related sections, references, appendices, tables or figures that are not located on the same page as the narrative text. Hypertext links in text can be designated by rectangles using thin lines or by blue text. A consistent method of designating links in a document avoids confusion. Hypertext links that open a file or document should be set to open the file or document in a new window. Using relative paths when creating hypertext links minimizes the loss of hyperlink functionality when submissions are loaded onto network servers; both absolute links that reference specific drives and links to root directories do not work once the submission is loaded. 目录（TOC）、超连接和书签可以为整个PDF文件提供必要的导航。文件大于等于5页时应放置超链接TOC和书签。在所有文件正文中使用超链接来链接至不在叙述性文字同一页面的支持性引用、相关部分、索引、附录、表格和图形。正文中的超链接可以使用细线方框或蓝色文本来显示。在同一文件中使用相同的方法指定链接能避免混淆。打开一个文件的超文本链接应设定为在一个新窗口打开该文件。在创建超文件链接时使用相关路径以减少申报资料上传至网络服务器时超链接功能丢失。申报文件一旦上传，指向具体驱动盘的绝对链接和根目录链接都不再有效。 The document TOC helps the reviewer navigate to the information of interest within the document that is not provided in the submission table of contents. For documents with a table of contents, provide bookmarks and hypertext links for each item listed in the table of contents including all tables, figures, publications, other references, and appendices that are essential for navigation through documents. The use of invisible rectangles and blue text in the table of contents for hypertext links avoids obscuring text. Other help for navigation includes a bookmark hierarchy identical to the table of contents; up to four levels deep in the hierarchy. 文件的TOC有助于审核人员导航至文件内相关信息，这些信息可能在申报目录中并没有。对于有目录的文件，为目录里所列的每个项目均提供书签和超链接，包括所有表格、图形、出版物、其它索引文件和附录对于整个文件中进行导航是很重要的。在目录中使用不可见的矩形和蓝色文本用作超链接以避免挡住文本。其它导航助手包括与目录相同的书签分级，可以达到四级。 When creating bookmarks and hyperlinks, set the magnification setting to “Inherit Zoom” so the destination page displays at the same magnification level used in the primary document. 在创建书签和超链接时，设定放大倍数为“继承放大”，这样最后页面显示与初始文件中的放大倍数是相同的。 INITIAL VIEW SETTINGS 初始视图设置 Set the Navigation Tab to open to “Bookmarks Panel and Page.” This sets the initial document view when the file is opened. If there are no bookmarks, set the Navigation Tab to “Page Only.” Page Layout and Magnification should be set to “Default.” 设定导航栏为打开“书签面板和页面”。这样就设置好打开时文档的初始视图。如果没有书签，设定导航栏为“仅显示页面”。页面和放大倍数应设置为“默认”。 PAGE NUMBERING 页码 In general, it is easier to navigate through an electronic document if the page numbers for the document and the PDF file are the same, with the initial page of the document numbered as page one. There is an exception when a document is split because of its size (e.g., > 400 MB) and the second or subsequent file is numbered consecutively to that of the first or preceding file. 一般来说，如果文件页码与PDF文件的页码相同，将文件初始页编号为第1页，很容易在整个电子文件中进行导航。当文件由于其尺寸（例如，大于400MB）而被拆分时，会有例外，第二部分或后续文件要继承第一部分或之前的部分连续编号。 NAMING PDF FILES PDF文件的命名 Use lower case characters and avoid using special characters except hyphens and underscores in file names. Special characters to avoid include punctuation, spaces, or other non-alphanumeric symbols. The current FDA validation criteria and the ICH eCTD specification both provide additional guidance on allowable special characters in file names. 在文件名称中应使用较少的字符，除连字符和下划线外，应避免使用特殊字符。特殊字符应避免包括标点符号、空格、或其它非字母符号。目前FDA验证标准和ICH eCTD标准都提供了允许在文件名称中使用的特定字符的额外指南。 SPECIAL CONSIDERATIONS FOR PROMOTIONAL MATERIAL 宣传材料的特殊考虑 Promotional materials submitted in PDF format may need special consideration to ensure accurate representation of the actual image. Since color varies from monitor to monitor, it is difficult to ensure that the reviewer will see exactly the same color as in the actual image. Provide images at the highest resolution and depth practical. For photographs, the image should be obtained with a resolution of at least 600 dpi. Documents that are available only in paper should be scanned at resolutions that will ensure the pages are legible both on the computer monitor and when printed; at least 600 dpi is recommended. Promotional material should be submitted according to its actual size when practical. When an image size is altered, the original dimensions must be stated. Images of three-dimensional promotional pieces must show all sides and components. 以PDF格式提交的宣传材料可能需要一些特殊考虑，以保证准确展示实际的图形。由于不同显示器色彩不同，很难保证审核人员能看到与实际图片完全相同的色彩。应使用最高分辨率和实际深度图片。对于照片，应使用至少600dpi的分辨率获得图片。只有纸质文件的情况下扫描分辨率应保证页面在电脑显示器上和打印出来时都很清晰，建议至少使用600dpi分辨率。宣传材料应根据其使用时的实际尺寸提供。如果需要转换图片尺寸，则要写明原始尺寸。三维图片宣传材料必须显示所有侧面和部分。
ICH建议了几种用于法规文件交换的格式，参见上述官网。
[2] http://www.color.org/
来源：http://zhuyujiao1972.blog.163.com/blog/static/9869472720168794945302/
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