Electronic common technical document

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The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Conference on Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG).

History[edit]

Version 2.0 of eCTD – an upgrade over the original CTD – was finalized on February 12, 2002,[1] and version 3.0 was finalized on October 8 of the same year.[2] As of August 2016, the most current version is 3.2.2, released on July 16, 2008.[3]

A Draft Implementation Guide for version 4.0 of eCTD was released in August 2012.[4] However, work stalled on the project. An additional Draft Implementation Guide was released in February 2015[5] Draft specifications and guides were issued in April 2016 by the ICH and the FDA, followed by a May 13 ICH "teleconference to discuss the guidance and any questions and clarifications needed."[6]

U.S.[edit]

On May 5, 2015, the U.S. Food & Drug Administration published a final, binding guidance document[7] requiring certain submissions in electronic (eCTD) format within 24 months. The projected date for mandatory electronic submissions is May 5, 2017 for New Drug Applications (NDAs), Biologic License Applications (BLAs), Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs).[8]

E.U.[edit]

The E.U. and its European Medicines Agency began accepting eCTD submissions in 2003.[9] However, in February 2015, the "EMA announced it would no longer accept paper application forms for products applying to the centralized procedure beginning 1 July 2015."[10] The EMA verified on that date that it would no longer accept "human and veterinary centralised procedure applications" and that all electronic application forms would have to be eCTD by January 2016.[11]

Governing specifications[edit]

An eCTD submission's structure is largely defined by the primary standard created by the ICH, the Electronic Common Technical Document Specification.[12] However, additional specifications may be applied in national and continental contexts. In the United States, the Food and Drug Administration (FDA) layers additional specifications onto its requirements for eCTD submissions, including PDF, transmission, file format, and supportive file specifications.[13][14] In the European Union, the European Medicines Agency's EU Module 1 specification as well as other QA documents lay out additional requiremements for eCTD submissions.[15][16]

Pharmaceutical point of view[edit]

CTD Pyramid.jpg

The eCTD has five modules:

  1. Administrative information and prescribing information
  2. Common technical document summaries
  3. Quality
  4. Nonclinical study reports
  5. Clinical study reports

A full table of contents could be quite large.

There are two categories of modules:

  • Regional module: 1 (different for each region; i.e., country)
  • Common modules: 2–5 (common to all the regions)

The CTD defines the content only of the common modules. The contents of the Regional Module 1 are defined by each of the ICH regions (USA, Europe and Japan).

IT point of view[edit]

eCTD (data structure)[edit]

The eCTD is a message specification for the transfer of files and metadata from a submitter to a receiver. The primary technical components are:

  • A high level folder structure (required)
  • An XML "backbone" file which provides metadata about content files and lifecycle instructions for the receiving system
  • An optional lower level folder structure (recommended folder names are provided in Appendix 4 of the eCTD specification)
  • Associated document type definitions (DTDs) and stylesheets.

Each submission message constitutes one "sequence". A cumulative eCTD consists of one or more sequences. While a single sequence may be viewed with web browser and the ICH stylesheet provided, viewing a cumulative eCTD requires specialized eCTD viewers.

The top part of the directory structure is as follows:

ctd-123456/0000/index.xml
ctd-123456/0000/index-md5.txt
ctd-123456/0000/m1
ctd-123456/0000/m2
ctd-123456/0000/m3
ctd-123456/0000/m4
ctd-123456/0000/m5
ctd-123456/0000/util

The string ctd-123456/0000 is just an example.


Backbone (header)[edit]

This is the file index.xml in the submission sequence number folder. For example:

ctd-123456/0000/index.xml

The purpose of this file is twofold:

  • Manage meta-data for the entire submission
  • Constitute a comprehensive table of contents and provide corresponding navigation aid.

Stylesheets[edit]

Stylesheets that support the presentation and navigation should be included. They must be placed in the directory:

ctd-123456/0000/util/style

See entry 377 in Appendix 4.

DTDs[edit]

DTDs must be placed in the directory:

ctd-123456/0000/util/dtd

See entries 371–76 in Appendix 4. They must follow a naming convention.

The DTD of the backbone is in Appendix 8. It must be placed in the above directory.

Business process (protocol)[edit]

The business process to be supported can be described as follows:

 Industry <-----> Message <-----> Agency

The lifecycle management is composed at least of:

  • Initial submission: should be self-contained.
  • Incremental updates: with its sequence number.

See also[edit]

References[edit]

  1. ^ "Electronic Common Technical Document Specification V 2.0" (PDF). ICH M2 Expert Working Group. 12 February 2002. Retrieved 13 August 2016. 
  2. ^ "Electronic Common Technical Document Specification V 3.0" (PDF). ICH M2 Expert Working Group. 8 October 2002. Retrieved 13 August 2016. 
  3. ^ "Electronic Common Technical Document Specification V 3.2.2" (PDF). ICH M2 Expert Working Group. 16 July 2008. Retrieved 13 August 2016. 
  4. ^ Finkle, J. (14 August 2012). "Fourth Time’s the Charm: eCTD 4.0 is coming!". Life Sciences. Computer Sciences Corp. Retrieved 13 August 2016. 
  5. ^ Mezher, M. (24 February 2015). "ICH Takes Step Toward New eCTD Version". Regulatory Focus. Regulatory Affairs Professionals Society. Retrieved 13 August 2016. 
  6. ^ Finkle, J. (31 May 2016). "eCTD 4: Yes, it’s still alive". Life Sciences Regulatory Technology. Computer Sciences Corp. Retrieved 13 August 2016. 
  7. ^ "Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications" (PDF). US FDA. Retrieved 29 October 2015. 
  8. ^ Underwood, Brandon. "The End of Paper Submissions". The eCTD Summit. GlobalSubmit. Retrieved 29 October 2015. 
  9. ^ Mezher, M. (26 February 2015). "Going Digital: EMA to Ditch Paper, Require Electronic Application Forms". Regulatory Focus. Regulatory Affairs Professionals Society. Retrieved 13 August 2016. 
  10. ^ Mezher, M. (1 July 2015). "Electronic Application Forms Mandatory for EU Centralized Procedure". Regulatory Focus. Regulatory Affairs Professionals Society. Retrieved 13 August 2016. 
  11. ^ "Regulatory information - Electronic application becomes mandatory today". European Medicines Agency. 1 July 2015. Retrieved 13 August 2016. 
  12. ^ "eCTD Specification and Related Files". International Conference on Harmonisation Multi-disciplinary Group 2 Expert Working Group. June 2015. Retrieved 13 August 2016. 
  13. ^ "Electronic Common Technical Document (eCTD)". Food and Drug Administration. 4 August 2016. Retrieved 13 August 2016. 
  14. ^ "eCTD Submission Standards" (PDF). Food and Drug Administration. 8 May 2015. Retrieved 13 August 2016. 
  15. ^ "Harmonised Technical Guidance for eCTD Submissions in the EU - Version 3.0" (PDF). European Medicines Agency. August 2013. pp. 7–8. Retrieved 13 August 2016. 
  16. ^ "EU Module 1". eSubmission. European Medicines Agency. Retrieved 13 August 2016. 

External links[edit]