FDA的eCTD文件格式规范 2019.8.19 英文.pdfVIP

Specifications for File Format Types Using eCTD Specifications Specificationsfor File Format Types Using eCTD Specifications Revision History Date Version Summary of Changes 2013-04-11 1.0 Initial version 2017-03-02 2.0 Updated version, new file formats added: • Document file types: .xls, .xlsx • Audio/Visual file types: .fla, .f4v, .mpg • Data file types: .csv • Modelling Simulation file types: .cmp, .wks, .lbr • Modelling Simulation Reporting file types: .lua, .sas, .r, .ctl 2017-11-15 3.0 Updated .doc and .docx accepted locations 2019-08-19 4.0 Updated .doc and .docx accepted locations 1 Specifications for File Format Types Using eCTD Specifications Specifications for File Format Types Using eCTD Specifications This document provides specifications for submitting file format types using eCTD specifications. It is a list of accepted file types and the eCTD locations in which those file types should be provided. I. General Information Documents should be provided in PDF searchable format. Images and other document types should be rendered into PDF format and retain searchable text whenever possible. Additional information related to PDF documents is available in the FDA technical specification FDA Portable Document Format (PDF) Specifications. II. Acceptable File Formats for Use in eCTD In most cases, files submitted in formats below should also be provided in PDF format for archival purposes, please reference the “Archive Format Copy” column to see if an alternative version of the document should also be provided.