Electronic Common Technical Document (eCTD)

The Electronic Common Technical Document (eCTD) is a standardized digital format used for submitting regulatory information to drug regulatory agencies, like the FDA or EMA. It organizes and packages scientific data, clinical trial results, manufacturing details, and safety information about a medicine into a structured, electronic format. This system streamlines the review process by allowing agencies to efficiently access, review, and track submissions electronically, replacing traditional paper-based methods. Overall, the eCTD enhances the efficiency, consistency, and security of drug approval processes worldwide.