eCTD Publishing

The electronic Common Technical Document (eCTD) has revolutionized regulatory submissions in the pharmaceutical industry. This standardized format for submitting a Marketing Authorization Applications (MAA) for medicinal products to health authorities offers numerous benefits for both applicants and regulators.

Overview of eCTD

The eCTD is an electronic version of the Common Technical Document (CTD), which organizes regulatory submissions into five modules:

• Administrative and prescribing information
• Overviews and summaries
• Quality documentation
• Non-clinical documentation
• Clinical documentation

eCTD submissions are structured using XML backbone files and PDF documents, ensuring a consistent organization across different regulatory regions

Key Advantages of eCTD Publishing

The use of eCTD management ensures compliance with latest global regulatory requirements and provides a comprehensive overview of submission statuses for different products across multiple geographic markets.

1. Improved Efficiency

2. Enhanced Review Process

3. Global Harmonization

The eCTD format facilitates submissions in multiple regions with minimal modifications, potentially saving months in bringing drugs to market in major global markets

4. Lifecycle Management

eCTD enables better management of the dossier lifecycle, providing a complete history of submissions and facilitating both internal and external interactions

5. Cost Reduction

For regulatory authorities, eCTD submissions reduce processing costs by automating operations that were previously labor-intensive and expensive with paper submissions

6. Improved Metadata Correction