CTD vs. eCTD

Attribute	CTD	eCTD
Format	Non-electronic format	Electronic format
Submission process	Manual submission	Electronic submission
Regulatory agency acceptance	Accepted by regulatory agencies	Preferred by regulatory agencies
Global adoption	Not globally adopted	Increasing global adoption

Introduction

Regulatory submissions in the pharmaceutical industry are crucial for getting new drugs approved for market. The Common Technical Document (CTD) and electronic Common Technical Document (eCTD) are two formats used for organizing and submitting regulatory information to health authorities. Both formats have their own set of attributes that make them unique. In this article, we will compare the attributes of CTD and eCTD to understand their differences and similarities.

Structure

The CTD is a paper-based format that consists of five modules: Module 1 contains administrative information, Module 2 contains summaries and overviews, Module 3 contains quality data, Module 4 contains nonclinical study data, and Module 5 contains clinical study data. Each module is further divided into sections and subsections to organize the information in a standardized manner. On the other hand, eCTD is an electronic format that follows the same structure as CTD but is submitted in a digital format. The eCTD is organized into five modules just like CTD, but the information is submitted electronically using XML files.

Submission Process

Submitting a CTD involves printing out the documents and physically mailing them to the health authorities. This process can be time-consuming and costly, as it requires printing, binding, and shipping the documents. In contrast, submitting an eCTD involves compiling the documents into electronic files and submitting them through a secure online portal. This process is more efficient and cost-effective, as it eliminates the need for printing and shipping physical documents. Health authorities can also review eCTD submissions more quickly and provide feedback electronically.

Review and Approval

When health authorities receive a CTD submission, they must manually review and evaluate the documents to ensure compliance with regulatory requirements. This process can be labor-intensive and prone to errors, as reviewers have to sift through large volumes of paper documents. On the other hand, eCTD submissions can be reviewed using electronic tools that facilitate navigation, searching, and annotation of the documents. Reviewers can easily access specific sections of the submission and provide feedback electronically, streamlining the review process and reducing the likelihood of errors.

Version Control

One of the challenges of using CTD is maintaining version control of the documents, especially when updates or revisions are made to the submission. Each time a change is made, a new version of the document must be printed and submitted to the health authorities, leading to potential confusion and errors. In contrast, eCTD allows for easier version control, as updates can be made to the electronic files without having to print and resubmit the entire submission. Health authorities can track changes and revisions more effectively in eCTD submissions, ensuring that the most up-to-date information is always available.

Accessibility

CTD submissions are limited in terms of accessibility, as they are physical documents that need to be stored and archived in a secure location. Retrieving information from CTD submissions can be time-consuming and cumbersome, especially if the documents are stored in multiple locations. On the other hand, eCTD submissions are stored electronically and can be accessed from anywhere with an internet connection. Health authorities can easily search, retrieve, and share information from eCTD submissions, making the regulatory review process more efficient and transparent.

Conclusion

In conclusion, both CTD and eCTD have their own set of attributes that make them unique formats for regulatory submissions in the pharmaceutical industry. While CTD is a paper-based format that requires physical submission and manual review, eCTD is an electronic format that streamlines the submission process and facilitates electronic review. The choice between CTD and eCTD ultimately depends on the specific requirements of the health authorities and the preferences of the pharmaceutical company. Regardless of the format chosen, it is important to understand the attributes of CTD and eCTD to ensure successful regulatory submissions.