The document discusses the electronic Common Technical Document (eCTD) format, which was agreed upon in 2001 as a standard for submitting regulatory information electronically to health authorities. An eCTD uses individual PDF documents arranged hierarchically according to the CTD structure and linked together using an XML backbone. It aims to simplify electronic submissions and reduce the workload for reviewers. Key benefits include improved accuracy and information management as well as better communication between industry and regulators. Some challenges include the need for appropriate tools and training as well as variations in regional implementation rules.

2. ➢After 6 months of CTD acceptance, in May 2001 eCTD was agreed
by Multidisciplinary 2, Expert Working Group (ICH M2 EWG).
➢eCTD (electronic Common Technical Document) is a standard format
of submitting Regulatory information (such as applications,
supplements, and reports) to the concerned Health Authorities (HAs).
➢It provides a harmonized solution to implement the Common
Technical Document (CTD) electronically.
➢An eCTD consists of individual documents in PDF format which are
arranged in a hierarchical form as per the CTD structure.
➢It also has an XML backbone which cross-links required documents
and provides information regarding the submission.

3. ➢ The purpose of introducing eCTD was to reduce the burden on the
reviewers of the HAs. It also simplifies the process of submission as all
the Regulatory authorities use it as a standard format.
➢It is maintained by eCTD Implementation Working group (IWG) in
accordance with the ICH Process.
➢The eCTD specification lists the criteria that will make an electronic
submission technically valid.
➢The focus of the specification is to provide the ability to transfer the
registration application electronically from industry to a regulatory
authority.
➢Industry to industry and agency to agency transfer is not addressed.

4. Why electronic?
✓ Improve the submission and review process
✓ Increase accuracy of the submission
✓ Decrease total costs

5. CHARACTERISTICS OF eCTD
1. Files Referenced in the XMLBackbone
REASONS:
a. It manages the large data for the entire submission and for each
document within the submission.
b. This XML backbone allows the eCTD submission to be viewed
via a web browser and can be loaded on a Web server

6. 2. The file formats that can be included in the eCTD are
Portable Document Format (PDF) and XML.
3. Other formats can be used for graphs and images. JPEG may be used
for higher resolution.
4. All eCTD Submissions Include Module 1 which contains
a. Company Name
b. Drug Name
c. Submission Type
d. Submission Date
e. Application Number
f. Sequence Number

7. Benefits of eCTD
✓ Make the reviewing of each application more easy
✓ Avoid omission of critical data or analyses
✓ Save time
✓ Better information management
✓ Support of Life Cycle Management

8. ✓ Immediate access to complete and up‐to‐date
information
✓ Reduced workload
✓ Better use of resources
✓ Simplified business process
✓ Better communication with industry

11. CHALLENGES
• Advantages sometimes perceived as disadvantages
➢PDFs
➢Hyperlinks
• Requires tools and trained technical experts
• Different implementation approach
• Regional rules vary
• Last minute changes not easy

12. Benefits
•Broader scope and standardization
Challenges
•Need to understand HL7 process / methodology
•Will require new tools
•Regional requirements