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 Harmonisation (ICH) in 2003. Today the CTD format is mandatory for marketing applications in Europe, Japan, and other regions, and is highly recommended by FDA. Since January 2010, the European Medicines Agency has required all applications in the centralized procedure to use the eCTD format. In February 2020, FDA released a revision to the 2015 regulatory guidance regarding eCTD. The following submission types must be submitted in eCTD format: New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Biologics License Applications (BLAs), Drug Master Files (DMFs), and commercial IND submissions. FDA has exempted all non-commercial INDs from mandatory eCTD format, including investigator-sponsored INDs and expanded access INDs (e.g., emergency use INDs and treatment INDs).
eCTD has five modules:
- Administrative and prescribing information
- Nonclinical study reports
- 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)
- 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, decreased response times to agency requests, and ultimately, a faster approval timeline.
- Facilitates collaboration between teams of document authors, reviewers, publishers, and external partners.
- Ability to submit dossiers to multiple global regulatory agencies with minimal changes.
- Supports efficient and effective application lifecycle management.
- Provides a convenient mechanism for information sharing during licensing, marketing, and other business partnership transactions.
CCSA uses the same software chosen by FDA (CBER/CDER Division) and Health Canada.