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The electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. eCTD technical document format development was done by International Conference on Harmonization (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). Details on the specification for the ICH eCTD can be found in the guidance document M2 eCTD: Electronic Common Technical Document Specification. Currently, eCTD is the preferred format for electronic submissions by U.S. Food and Drug Administration.
Although originally the CTD and the eCTD were designed for marketing applications, they could apply equally to other submission types, including INDs, master files, advertising material, and promotional labeling.
In June 2008, FDA has issued guidelines for organizing the electronic regulatory document filing using the eCTD tools. This guidance discusses issues related to the electronic submission of applications for human pharmaceutical products and related submissions, including abbreviated new drug applications (ANDAs), biologics license applications (BLAs), investigational new drug applications (INDs), new drug application (NDAs), master files (e.g., drug master files), advertising material, and promotional labeling. At this time, this does not include applications supporting combination products.
As per guidance, since a document is a collection of information that includes forms, reports, and datasets, it is recommended that when making an electronic submission, each document should be provided as a separate file.
Five Modules:
Any type of document, whether a marketing application, an investigational application, or a related submission should be organized in five modules in the CTD: module 1 includes administrative information and prescribing information, module 2 includes CTD summary documents, module 3 includes information on quality, module 4 includes the nonclinical study reports, and module 5 includes the clinical study reports.
Comprehensive Table of Contents Headings and Hierarchy:
The organization of the documents making the submission must follow the “Comprehensive Table of Contents Headings and Hierarchy”. If any other headings are required a prior communication must be established with the agency before the submission. Any file submitted that does not fall into any of the categories in the Comprehensive Table of Contents Headings and Hierarchy may not be reviewed.
eCTD Backbone Files:
Once a specific application in electronic format based on this guidance is done the subsequent submissions to the application, including amendments and supplements, should include eCTD backbone files reference. One can include the information by reference by providing in the text of the document (1) the application or master file number, (2) the date of submission (e.g., letter date), (3) the document name, and (4) the page number of the referenced document along with a hypertext link to the location of the information.
Scanned vs. Text-based Documents:
Scanned documents submitted electronically as images are not as useful for review as documents that are text based. Image-based documents are more difficult to read and cannot be electronically searched. Since it takes longer to print image-based documents, and they occupy more storage space than text-based documents as far as possible text-based documents may be submitted.
Naming Electronic Files:
To function properly, the eCTD backbone files must have specific names (e.g., index.xml, us-regional.xml). For other files without a specified name, a name that is indicative of the contents (e.g., protocol-101) should be provided. However, the file name should be less than or equal to 64 characters including the appropriate file extension. Only lower case letters, numbers, or hyphens should be used in the name. Blank spaces are not recommended. When naming files, it is important to remember that — to avoid truncation — the length of the entire path of the file should not exceed 230 characters.
Naming Folders:
The main submission, regional administrative folders, and certain subfolders should have specific names for proper and efficient processing of the submission.
Recommended File Formats:
The following file formats are recommended for the use:
• PDF for reports and forms
• SAS XPORT (version 5) transport files (XPT) for datasets
• ASCII text files (e.g., SAS program files, NONMEM control files) using txt for the file extension
• XML for documents, data, and document information files
• Style sheets (XSL) and document type definition (DTD) for the XML document information files
• Microsoft Word for draft labeling (because Microsoft Word can change, check our Web site for the current version)
More details can be found at:
1. Providing Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications,http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072349.pdf
2. The eCTD Backbone File Specification for Study Tagging Files, http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163560.pdf
The electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. eCTD technical document format development was done by International Conference on Harmonization (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). Details on the specification for the ICH eCTD can be found in the guidance document M2 eCTD: Electronic Common Technical Document Specification. Currently, eCTD is the preferred format for electronic submissions by U.S. Food and Drug Administration.
Although originally the CTD and the eCTD were designed for marketing applications, they could apply equally to other submission types, including INDs, master files, advertising material, and promotional labeling.
In June 2008, FDA has issued guidelines for organizing the electronic regulatory document filing using the eCTD tools. This guidance discusses issues related to the electronic submission of applications for human pharmaceutical products and related submissions, including abbreviated new drug applications (ANDAs), biologics license applications (BLAs), investigational new drug applications (INDs), new drug application (NDAs), master files (e.g., drug master files), advertising material, and promotional labeling. At this time, this does not include applications supporting combination products.
As per guidance, since a document is a collection of information that includes forms, reports, and datasets, it is recommended that when making an electronic submission, each document should be provided as a separate file.
Five Modules:
Any type of document, whether a marketing application, an investigational application, or a related submission should be organized in five modules in the CTD: module 1 includes administrative information and prescribing information, module 2 includes CTD summary documents, module 3 includes information on quality, module 4 includes the nonclinical study reports, and module 5 includes the clinical study reports.
Comprehensive Table of Contents Headings and Hierarchy:
The organization of the documents making the submission must follow the “Comprehensive Table of Contents Headings and Hierarchy”. If any other headings are required a prior communication must be established with the agency before the submission. Any file submitted that does not fall into any of the categories in the Comprehensive Table of Contents Headings and Hierarchy may not be reviewed.
eCTD Backbone Files:
Once a specific application in electronic format based on this guidance is done the subsequent submissions to the application, including amendments and supplements, should include eCTD backbone files reference. One can include the information by reference by providing in the text of the document (1) the application or master file number, (2) the date of submission (e.g., letter date), (3) the document name, and (4) the page number of the referenced document along with a hypertext link to the location of the information.
Scanned vs. Text-based Documents:
Scanned documents submitted electronically as images are not as useful for review as documents that are text based. Image-based documents are more difficult to read and cannot be electronically searched. Since it takes longer to print image-based documents, and they occupy more storage space than text-based documents as far as possible text-based documents may be submitted.
Naming Electronic Files:
To function properly, the eCTD backbone files must have specific names (e.g., index.xml, us-regional.xml). For other files without a specified name, a name that is indicative of the contents (e.g., protocol-101) should be provided. However, the file name should be less than or equal to 64 characters including the appropriate file extension. Only lower case letters, numbers, or hyphens should be used in the name. Blank spaces are not recommended. When naming files, it is important to remember that — to avoid truncation — the length of the entire path of the file should not exceed 230 characters.
Naming Folders:
The main submission, regional administrative folders, and certain subfolders should have specific names for proper and efficient processing of the submission.
Recommended File Formats:
The following file formats are recommended for the use:
• PDF for reports and forms
• SAS XPORT (version 5) transport files (XPT) for datasets
• ASCII text files (e.g., SAS program files, NONMEM control files) using txt for the file extension
• XML for documents, data, and document information files
• Style sheets (XSL) and document type definition (DTD) for the XML document information files
• Microsoft Word for draft labeling (because Microsoft Word can change, check our Web site for the current version)
More details can be found at:
1. Providing Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications,http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072349.pdf
2. The eCTD Backbone File Specification for Study Tagging Files, http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163560.pdf
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