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 CTD became the mandatory format for new drug applications in the EU and Japan in 2003, and for FDA, United States in 2017. More information: An electronic version of the Common Technical …

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

Electronic submissions must use the version of eCTD currently supported by FDA, which is specified in the FDA Data Standards Catalog (/industry/fda-data-standards-advisory-board/study-data-standards …

Mar 12, 2025 · eCTD v4.0 is primarily a format change that will provide users with new capabilities. This guide briefly explores the evolution of the eCTD format, the upcoming changes in the next major …

In other words, an eCTD is the submission of PDF documents, stored in the eCTD directory structure, accessed through the XML backbone and with the files integrity guaranteed by the MD5 Checksum.

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

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 …

Jul 23, 2025 · This format is mandated by major health authorities like the USFDA, EMA, and CDSCO. This tutorial explains the essential steps and technical requirements for compiling eCTD submissions.

1 day ago · The Electronic Common Technical Document (eCTD) is the mandatory, globally harmonized format for submitting regulatory applications for new drugs and biologics to health authorities. This …