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eCTD Format

Meaning

The eCTD Format, or electronic Common Technical Document Format, is a globally standardized structure and organization for the submission of regulatory applications to health authorities for new drug, biologic, and certain medical device products. This standardized electronic submission format ensures that the vast volume of scientific, clinical, and manufacturing data is presented in a consistent, searchable, and reviewable manner across multiple regulatory jurisdictions, streamlining the review process. Adherence to this format is mandatory for major global submissions.