This document provides instructions on how the reader may be presented eCTD content in a viewing or display tool. The location of keywords on headings may be different than the assignment in the...

As of May 2024, the Implementation Guide and Controlled Vocabulary documents were split into two different packages to enable Controlled Vocabulary Versioning. See the Implementation Guide …

In November 2017, China Food and Drug Administration (CFDA) publishes draft eCTD structure for drug registration for public consultations. This is a big transition for China to move from paper submission …

The eCTD format is regarded as the principal electronic submission format in EU for human medicinal products and is the only electronic format that is accepted by the EMA (except for some specified …

Dec 21, 2025 · For US sponsors, the FDA mandates electronic submissions in eCTD format for most INDs, NDAs, and BLAs under the Electronic Submissions Gateway (ESG). The structure, …

The regulatory requirement for submitting eCTD is that it must be submitted in a structured format which is discussed below in detail. Structure And Components Of eCTD

Annual Report: A brief description of the drug’s actions... Annual Report: A summary of all IND safety reports... Annual Report: A list of subjects who died... Annual Report: A list of subjects who...

Guidance for Industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

This technical specifications document, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not create any rights for any person …

This group has developed and begun to implement the eCTD across the ICH partner and observer regions. The group has developed a change control process to monitor implementation progress and …