Electronic common technical document

CTD Pyramid

Electronic Common Technical Document (eCTD) is a standard format for the submission of regulatory information to drug regulatory authorities. The eCTD harmonizes the submission process for pharmaceuticals and is widely used by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Japan Pharmaceuticals and Medical Devices Agency (PMDA), among others. It is designed to facilitate the creation, review, lifecycle management, and archival of electronic submissions.

Overview

The eCTD is an interface for the pharmaceutical industry to agency transfer of regulatory information while taking into consideration the need to protect intellectual property and personal data. It is based on the International Conference on Harmonisation (ICH) specifications. The eCTD is structured in a hierarchical format and is composed of five modules:

• Module 1: Regional Administrative Information (specific to each regulatory region)
• Module 2: Summaries (overview of the entire submission)
• Module 3: Quality (information on drug substance, drug product, and manufacturing)
• Module 4: Nonclinical Study Reports (toxicology reports)
• Module 5: Clinical Study Reports (results of clinical trials)

Benefits

The adoption of the eCTD format offers several benefits over paper-based submissions, including:

• Improved efficiency in the submission and review process
• Enhanced quality of submissions through standardization
• Easier lifecycle management of a drug application
• Reduced paper usage, contributing to environmental sustainability

Challenges

Transitioning to eCTD format can present challenges, such as:

• Initial investment in eCTD management software and training
• Compliance with varying regional requirements within Module 1
• Ensuring data integrity and security

Future Directions

The eCTD format continues to evolve, with updates focusing on enhancing usability, supporting new types of content, and improving integration with other regulatory information management systems. Future developments may include more advanced functionalities for lifecycle management and further harmonization of global submission standards.