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eCTD

eCTD

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**eCTD**

What is eCTD?

The electronic Common Technical Document (eCTD) is a standard format for submitting information to regulatory authorities like the FDA, EMA, and Health Canada for drug applications, including new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs). It is used to organize and submit documents electronically, replacing paper-based submissions. The eCTD provides a structured, searchable, and standardized way to present data, facilitating review and assessment by regulatory agencies.

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