eCTD stands for "electronic Common Technical Document." It is a standardized format for submitting regulatory information to health authorities, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Purpose of eCTD?
The eCTD format was developed to facilitate the electronic submission, review, and lifecycle management of regulatory applications for pharmaceuticals and other regulated products. It is based on the International Council for Harmonisation (ICH) Common Technical Document (CTD) format.
Modules in eCTD?
The eCTD Structure comprises five modules: administrative information, product information, quality information, nonclinical study reports, and clinical study reports. These modules contain documents providing a comprehensive drug development process overview. The Structure ensures that all necessary information is provided to regulatory authorities in a well-organized manner.
Benefits of eCTD:
eCTD has several benefits over traditional paper-based submissions.
One of the primary benefits is its ability to simplify the submission process.
With eCTD, regulatory submissions can be easily compiled, submitted, and tracked.
Additionally, eCTD provides a standard format for regulatory submissions, making it easier for regulatory authorities to review and process submissions.
It also reduces the chances of errors in the submission process, as electronic submissions can be automatically validated for completeness and accuracy.
Another benefit of eCTD is its ability to improve the efficiency of the review process.
With electronic submissions, regulatory authorities can easily access, review, and archive regulatory submissions, reducing the time and resources required for the review process. This, in turn, leads to faster approvals, saving time and money for pharmaceutical companies.
eCTD Submissions in a Nutshell
As a leading authority in regulatory compliance, the FDA offers invaluable guidance on eCTD submissions. Whether you're dealing with Chemistry, Manufacturing, and Controls (CMC) modules, Clinical Study Reports (CSRs), or Annual Reports, following FDA recommendations is essential for a smooth application process.
For CMC modules (Modules 2-3), it's crucial to reference the FDA's "M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use Guidance for Industry". This granular Structure is designed to help avoid issues throughout the application lifecycle, so resist the temptation to combine sections.
Regarding CSRs (Module 5), the FDA provides useful guidance titled "The Comprehensive Table of Contents Headings and Hierarchy". This recommends dividing CSRs into three sections: synopsis, report body, and individual appendices. This Structure helps the reviewer and author navigate information more efficiently and track changes easily.
Annual Reports, used from product development through post-approval activities, must contain information and documents for all applicable sections outlined in the FDA's "The Comprehensive Table of Contents Headings and Hierarchy". Common sections include nonclinical, clinical, and safety information summaries, labeling changes, manufacturing changes, and significant new information.
While eCTD is the preferred format for most submissions, certain types of submissions are exempt, including Type III DMFs (providing information on packaging or packaging materials in support of drug, generic drug, or biologic applications) and certain positron emission tomography (PET) drug products and certain Type II DMFs supporting PET drugs or noncommercial submissions or applications.
For additional information, please visit www.fda.gov/ectd to find all relevant guidance and technical specifications for eCTD.
If you need guidance or assistance with eCTD submissions, contact a team member here to get started.
Conclusion:
In conclusion, eCTD is a significant development in the pharmaceutical industry that simplifies the submission process and improves the efficiency of the review process. Its standardized Structure ensures that all necessary information is provided to regulatory authorities in a well-organized manner, reducing the chances of errors in the submission process. eCTD is a crucial tool for pharmaceutical companies looking to submit accurate and compliant electronic submissions.
Reach out to DDReg at info@ddregpharma.com to know more about eCTD submissions.