Annual Report: A brief description of the drug’s actions... Annual Report: A summary of all IND safety reports... Annual Report: A list of subjects who died... Annual Report: A list of subjects who...

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 …

In November 2017, China Food and Drug Administration (CFDA) publishes draft eCTD structure for drug registration for public consultations. This is a big transition for China to move from paper submission …

For eCTD submissions within EU, the EU Module 1 eCTD Specification (see link below) should be used. The eCTD format is mandatory to use for all submission types related to Marketing Authorisation for …

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.

Sep 8, 2022 · Celegence explains the structure of the Electronic Common Technical Document (eCTD) used for new drug and biologics submissions.

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

4 days ago · Learn what is the eCTD format and how this standardized structure streamlines drug and biologics submissions to regulatory agencies like the FDA and EMA for faster approvals.

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 …

Today, the eCTD format remains the only globally approved and ICH-recommended standard. While it has been in use for more than 15 years, it is the mandated submission format for drug applications …