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.

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 …

These eCTD resources, including FDA industry guidances, submission standards, a data standards catalog, eCTD v4.0 implementation, and more, will help provide direction in the submission process.

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 …

Sep 19, 2024 · Documentation, files, and links provide information on how to submit eCTD v4.0-based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the Center for …

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 …

For eCTD 4.0 in Japan, clinical studies are accepted in CDISC standard using ADaM and SDTM formats, similar to the U.S., though JP requires additional keywords for the studies.

Research (CDER) or the Center for Biologics Evaluation and Research (CBER). The Guide supplements the guidance for industry Providing Regulatory Submissions in Electronic Format — Certain Human...

This course will walk you through the essential steps of submitting electronic submissions to the Center for Drug Evaluation and Research (CDER), and can serve as a resource for questions about the...