eCTD Modules
The eCTD is the standard format for submitting applications, amendments, supplements, and reports to regulatory
agency in many countries.
Electronic submissions of standardized study data will be required for the following submission types:
- Certain investigational new drug applications (INDs)
- New drug applications (NDAs)
- Abbreviated new drug applications (ANDAs)
- Certain biologics license applications (BLAs)
Note: This requirement also includes all subsequent submissions, including amendments, supplements, 59 and reports to one of the submission types identified above.