Oct 4, 2024 · The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics …

The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to transfer regulatory information to regulatory agencies.

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 …

Mar 12, 2025 · The latest version of the Electronic Common Technical Document (eCTD), known as eCTD v4.0, has been finalized and is now being implemented worldwide. This updated version …

Jul 23, 2025 · The Electronic Common Technical Document (eCTD) has become the global standard for regulatory submissions in the pharmaceutical industry. This format is mandated by major health …

1 day ago · The eCTD hierarchy is a standardized, modular structure used to organize this data, streamlining the review process for regulatory bodies worldwide. This structure allows for efficient …

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 eCTD Technical Conformance Guide (Guide) provides specifications, recommendations, and general considerations on how to submit electronic Common Technical Document (eCTD)-based …

Nov 26, 2025 · The Electronic Common Technical Document (eCTD) is a standard format for submitting regulatory information to drug regulatory agencies around the world. The latest version of eCTD, …

This Controlled Vocabulary Package contains the eCTD v4.0 Code List and associated Genericode files. Note that these documents need to be used in conjunction with the Regional/Module 1 documents …