Sep 19, 2024 · CDER and CBER are accepting new regulatory applications in eCTD v4.0 format as of September 16, 2024. More information can be found on the eCTD page. Future …

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

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 …

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 …

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 …

Electronic Common Technical Document (eCTD) submissions have transformed sponsor companies' interactions with global health authorities. Over the past two decades, eCTDs …

Dec 12, 2023 · Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues to evolve as the pharmaceutical industry adapts to changing …

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

eCTD (electronic Common Technical Document) is a standard format of submitting Regulatory information (such as applications, supplements, and reports) to the concerned Health …

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 …