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What is eCTD?

eCTD is the electronic transfer of information to regulatory agencies based on the Common Technical Document (CTD) format. eCTD utilizes PDF documents linked via XML backbone.

The guidance on CTD was finalized by the International Conference on Harmonization (ICH) in 2003. Today the CTD format is mandatory for paper-based marketing applications in Europe, Japan, Canada, and other regions, and is highly recommended by FDA. The eCTD format has become mandatory in key regions for electronic submissions. Since January 2010, the European Medicines Agency has required all applications in the centralized procedure use the eCTD format. FDA released the final binding regulatory guidance regarding eCTD on May 5, 2015, which set in motion a 36-month timeline. The following submission types must be submitted in eCTD format beginning May 5, 2017: New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Biologics License Applications (BLA), and Drug Master Files (DMF). IND submissions will be required to be submitted in eCTD format on May 5, 2018. FDA has exempted all non-commercial INDs from mandatory eCTD format. This includes investigator-sponsored INDs and expanded access INDs (eg, emergency use INDs and treatment INDs).

eCTD Structure

eCTD has five modules:
  1. Administrative and prescribing information
  2. CTD summaries
  3. Quality
  4. Nonclinical study reports
  5. Clinical study reports
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)

eCTD Advantages

  • The eCTD dossier becomes the single authoritative regulatory archive, thus reducing the use and costs associated with producing and storing paper dossiers.
  • Enhanced ability to organize, prepare, and manage submission content.
  • Opportunity for streamlined interactions with agency reviewers, increase response times to agency requests, and ultimately lead to a faster approval timeline.
  • Facilitating collaboration between teams of document authors, reviewers, publishers and external partners.
  • Ability to submit dossiers to multiple global regulatory agencies with minimal changes.
  • Supporting efficient and effective submission lifecycle management
  • Providing a convenient mechanism for information sharing during licensing, marketing and other business partnership transactions.
  • Multiple people can access the same documents simultaneously.

Endorsement

CCSA uses the same software chosen by FDA (CBER/CDER Division).