FDA PORTABLE DOCUMENT FORMAT (PDF) SPECIFICATIONS 3.1 版說明

一、PDF版本

二、文件加密

三、文件字型

四、文件的版面配置與尺寸

五、PDF原始檔

六、PDF轉檔設定

七、PDF檔案的壓縮

八、顏色校對

九、行銷材料、手冊 Promotional Material

十、附件:FDA PORTABLE DOCUMENT FORMAT (PDF) SPECIFICATIONS 3.1

根據 2012-01-20 發佈的 FDA PORTABLE DOCUMENT FORMAT (PDF) SPECIFICATIONS 3.1版,FDA 對於 PDF 檔案格式,有如下之規範:

PDF版本

基本規範


FDA 接受的PDF版本為 1.4~1.7版,必須可以使用標準安裝的Adobe Acrobat 8.0直接開啟,不能外掛任何軟體。

目前有客戶亦要求所提供之文件必須使用PDF 1.4版,此部份需特別留意。

何謂PDF版本

這裡指的PDF版本並非是任何PDF軟體的版本,而是根據Adobe公司提交給ISO組織的標準所制定成為ISO 32000開放標準。如果與原Adobe公司所推出的Acrobat軟體版本比較,PDF版本可對照如下:

1993 – PDF 1.0 / Acrobat 1.0

1994 – PDF 1.1 / Acrobat 2.0

1996 – PDF 1.2 / Acrobat 3.0

2000 – PDF 1.3 / Acrobat 4.0

2001 – PDF 1.4 / Acrobat 5.0

2003 – PDF 1.5 / Acrobat 6.0

2005 – PDF 1.6 / Acrobat 7.0

2006 – PDF 1.7 / Acrobat 8.0

2006 – PDF 1.7 / Acrobat 8.2

2008 – PDF 1.7, Adobe Extension Level 3 / Acrobat 9.0

2009 – PDF 1.7, Adobe Extension Level 5 / Acrobat 9.1

如何查看目前PDF檔案的版本

使用 Acrobat Reader 打開PDF文件後,點選 檔案 內容 後,就可以得知該檔案在轉檔時採用的PDF版本:

設定轉檔工具產生特定版本的PDF

4.1 Adobe Acrobat

點選 開始 印表機 Adobe PDF ,開啟 Adobe PDF 印表機

點選 內容 喜好設定 編輯

點選 相容性,即可設定所需要的PDF版本。以 Acrobat Adobe 9.0專業版而言, 系統預設為1.5,最高可以支援到最新的PDF 1.7版。

4.2 PDF Creator

點選 開始 程式集 PDFCreator PDFCreator ,打開PDFCreator PDF列印監視器

點選 印表機 選項,開啟設定檔, 即可調整產生之PDF版本。系統預設是1.4,最高可以支援到PDF 1.5版。

4.3 PrimoPDF

點選 開始 程式集 PrimoPDF PrimoPDF Settings,打開PrimoPDF的選項設定程式

點選 Options,就可以看到設定PDF 版本的選項。系統預設版本是1.3,最高支援到PDF 1.5版

4.4 CutePDF

透過免費版本的CutePDF所產生的PDF版本為 1.4 ,無法調整為其它版本。

4.5 doPDF

透過免費版本的doPDF所產生的PDF版本為 1.5 ,無法調整為其它版本。

4.6 Microsoft Office 2007/2010

透過 Microsoft Office 2007以上版本之另存新檔功能所產生之PDF檔案版本為1.5,無法調整為其它版本。

4.7 Fuji Xerox C3370 

透過掃瞄器自動產生的PDF版本為 1.3 ,無法調整為其它版本。 (請勿使用於送件文件之產生

4.8 RICOH AFicio MP C2051

透過掃瞄器自動產生的PDF版本為 1.4 ,無法調整為其它版本。

文件加密

請勿使用任何安全性之設定,例如密碼開啟保護或是防止修改、列印等等,避免Review人員無法在文件上做標示或任何紀錄,影響Review進度。

文件字型

因為您無法事先得知Reviewer的電腦內是否安裝有其它字型,為避免文件在別台電腦開啟時產生錯誤,或是打開檔案後格式不對等等問題,請儘可能不要使用非電腦標準內建的字型。

下表為一般狀況下,電腦內建之標準字型

List of Standard Fonts

Font type Font name
Sans Serif Arial
Arial Italic
Arial Bold
Arial Bold Italic
Non Proportional Courier New
Courier New Italic
Courier New Bold
Courier New Bold Italic
Serif Times New Roman
Times New Roman Italic
Times New Roman Bold
Times New Roman Bold Italic
Other Symbol
Zapf Dingbats

根據FDA的建議,文件內容敘述請用Times New Roman字型,字體大小為12表格使用字體大小為910註腳字體大小為10。除非版面完整需要,否則僅可能不要使用過小的字體。

文件內容儘可能避免使用在黑白印表機無法清楚辨識的顏色,尤其是淺色字體,建議的字體顏色為黑色,而超連結部份則請採用藍色。文件在送件前請務必先用黑白印表機試列印,以驗證是否可以清楚辨視所有的內容。

文件的版面配置與尺寸

版面配置並無強迫規定,但整份文件請維持一致性。

文件尺吋請使用A4Letter規格。版面左側請保留至少四分之三吋為裝訂區,右側則最少保留八分之三吋的空間。如果文件版面採用橫向配置,則請在文件上方保留四分之三吋的空間。頁首及頁尾請勿跨出邊界。

如果有超大尺寸的CAD圖或是行銷材料,則請依實際尺吋產生PDF檔案。

PDF原始

除非不得以,否則請儘可能的使用原始檔,例如Word、 Excel或是軟體直接透過「列印」到PDF印表機的方式輸出PDF檔。透過文件掃瞄或圖片轉出的PDF檔,解析度通常會比較差,而且Reviewer可能無法使用文字搜尋或複製文字等功能。因此,針對由掃瞄產生的PDF檔案,必須掃瞄或轉換成「可搜尋的PDF」(Searchable PDF)。

建立或轉換成「可搜尋的PDF」,需要使用 Adobe Acrobat或是ABBYY FineReader 11等軟體才可以完成。目前新豐跟總公司使用的影印機(RICOH C2051或FUJI XEROX C3370)都無法直接輸出「可搜尋的PDF」。

PDF轉檔設定

透過掃瞄取得的文件,解析度請至少設為300dpi,以滿足螢幕跟列印時均可以取得清晰的效果。不同類別的文件,請請參考下列表列的建議解析度進行掃瞄:

掃瞄解析度

文件類別 解析度
手寫 300 dpi (black ink)
繪圖機列印的圖形 300 dpi
黑白圖片或照片 600 dpi (8 bit 灰階)
彩色圖片或照片 600 dpi (24 bit RGB)
Gels 及 karyotypes 600 dpi (8 bit 灰階)
High pressure liquid chromatography 300 dpi

PDF檔案的壓縮

透過適當的壓縮,可以在不降低文件品質的狀況下有效的替檔案進行減肥的工作。

以Adobe Acrobat為例,在 進階 PDF最佳化程式 裡面,採用 ZIPCCITT Group 4 的壓縮可以有效的減少檔案大小。

Adobe Acrobat 裡面還有提供一個「為快速Web檢視最佳化PDF」的選項,啟用之後轉出的PDF檔,除了可以降低檔案大小之外,還可以加快檔案開啟的速度。

顏色校對

因為不同的電腦螢幕多多少少都有色差問題,所以很難確保Reviewer能夠看到圖片或圖譜的「真實色彩」。對此,FDA建議圖片或圖譜使用的校色標準為「CMYK模式」,以確保文件輸出時的色彩得以一致。

如需使用色彩管理的設定,請使用 PDFCreator 或是 Adobe Acrobat輸出PDF檔案。

PDFCreator 的設定如下圖:

Adobe Acrobat 則在印表機設定裡:

行銷材料、手冊 Promotional Material

行銷所使用的檔案文件,請使用原尺吋掃瞄,解析度請設定為600 dpi。如果必須裁切尺吋,則請務必標註實際尺吋大小。圖片掃瞄亦請使用600 dpi 解析度設定。立體的材料則請秀出各個面向及所有的組成元件。

附件FDA PORTABLE DOCUMENT FORMAT (PDF) SPECIFICATIONS 3.1

FDA PORTABLE DOCUMENT FORMAT (PDF) SPECIFICATIONS

Revision History

Date Summary of Changes Version
2005-04-08 Initial version 1.0
2008-06-04 Changed “Bookmarks and Page” to “Bookmarks Panel and Page” in Open Dialog Box section 2.0
2011-12-20 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 3.0
2012-1-20 Clarified language on acceptable PDF versions for documents; added page numbers 3.1

FDA PORTABLE DOCUMENT FORMAT (PDF) SPECIFICATIONS

PURPOSE

These specifications are for submitting documents in Portable Document Format (PDF). The purpose of this document is to provide specifications for submitting PDF files that align with the ICH M2 recommendations 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.

VERSION

PDF versions 1.4 through 1.7 are acceptable. Submitted PDF files should be readable by Adobe Acrobat 8.0, 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.

SECURITY

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.

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.

FONTS

Embed all 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. Font availability to the reviewer is ensured if all fonts are 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 fonts are fully embedded prior to submission.

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 those listed in Table 1.

Table 1: List of Standard Fonts

Font type Font name
Sans Serif Arial
Arial Italic
Arial Bold
Arial Bold Italic
Non Proportional Courier New
Courier New Italic
Courier New Bold
Courier New Bold Italic
Serif Times New Roman
Times New Roman Italic
Times New Roman Bold
Times New Roman Bold Italic
Other Symbol
Zapf Dingbats

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.

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.

PAGE ORIENTATION

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.

PAGE SIZE AND MARGINS

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.

SOURCE OF ELECTRONIC DOCUMENTS

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.

METHODS FOR CREATING PDF DOCUMENTS AND IMAGES

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.

Table 2: Scanning Resolution

Document type Resolution
Handwritten notes 300 dpi (black ink)
Plotter output graphics 300 dpi
Photographs – black and white 600 dpi (8 bit gray scale)
Photographs – color 600 dpi (24 bit RGB)
Gels and karyotypes 600 dpi (8 bit grayscale depth)
High pressure liquid chromatography 300 dpi

IMAGE COMPRESSION TO REDUCE FILE SIZE

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.

Zip/Flate (one technique with two names) for lossless compression of color and grayscale images is specified in Internet RFC 1950 and RFC 1951.

using the color profile provided by CMYK ensure color consistency for printing. The International Color Consortium (ICC) color profile specification is used when PDF documents are printed.

USE OF THUMBNAILS

PDF documents do not need embedded thumbnails.

HYPERTEXT LINKING AND BOOKMARKS IN TEXT AND TABLE OF CONTENTS

Hypertext links and bookmarks improve navigation through PDF documents. Use hypertext links throughout the body of the document 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. 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.

The document table of contents 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 4 levels deep in the hierarchy.

When creating bookmarks and hyperlinks, set the magnification setting to “Inherit Zoom” so the destination page displays at the same magnification level that the reviewer is using for the rest of the document.

INITIAL VIEW SETTINGS

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.”

PAGE NUMBERING

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., > 100 MB) and the second or subsequent file is numbered consecutively to that of the first or preceding file.

NAMING PDF FILES

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 (e.g., / : ? <

> | “ % # +). The current FDA validation criteria and the ICH eCTD specification both provide additional guidance on allowable special characters in file names.

SPECIAL CONSIDERATIONS FOR PROMOTIONAL MATERIAL

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.

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