2024年10月4日 · The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and …

2024年9月19日 · 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 …

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

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

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 …

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 …

Welcome to the Electronic Common Technical Document (eCTD): Overview and Submission Web-Based Training (WBT) course. This course will walk you through the essential steps of...

The Electronic Common Technical Document (eCTD) allows for the electronic submission of the Common Technical Document (CTD) from applicant to regulator. While the table of contents is …

2025年3月12日 · Discover the key updates in eCTD v4.0 and learn how to effectively transition from eCTD v3.2.2 to enhance regulatory submissions and streamline communication with …

The agreement to assemble all the Quality, Safety and Efficacy information in a common format (called CTD - Common Technical Document ) has revolutionised the regulatory review …