The document discusses the Common Technical Document (CTD) format, which was created by the International Conference on Harmonisation to standardize the submission of documentation for drug approval across regions. It provides a five-module structure for organizing quality, safety, efficacy and other information. While CTD helped streamline submissions, the electronic CTD (eCTD) was later developed to further facilitate electronic transfer and review of documentation between regulators and industry. eCTD utilizes XML formatting and allows lifecycle management of submissions but implementation presents challenges around file formats, regional rules and last minute changes.

1. REGISTRATION OF DRUG PRODUCT
IN OVERSEAS MARKET
(CTD & ECTD)

2. NEED OF CTD…
Initially to obtain permission for export/import it was mandatory to
submit different documents and large amount of data
For organising information each applicants were try to use different
approaches
It leads to …
Approval process more complex
Reviewing process more difficult
Omission of critical data or analyses
Result in unnecessary delays in approvals.
Thus, there was need of a common format of submission which will help in
overcoming these hurdles

3. HISTORY
1996: Industry proposed CTD but ICH regulators were hesitant to
the review process
Regulators asked industry to do a feasibility study.
May 1996: Study was conducted to evaluate the time took to convert
an FDA new drug application into an European Medicines Agency
(EMA) submission and the reverse.
Regulators quickly saw the potential value of harmonizing
submission formats

4. Nov 2000: CTD was officially signed at San Diego, USA.
1 July 2003: The use of the CTD format is mandatory.
Nov 2005: The ICH Steering Committee adopted a new
codification system
2009: India adopt CTD format for Technical requirements for
registration of biological products

5. WHAT IS CTD?
The CTD is a set of specifications of a dossier
(Record/Documents) for the registration of medicines.
CTD is an internationally agreed “well structured common
format” for the organization of the technical requirements that
is to be submitted to the regulatory authority as an application
for the registration of pharmaceuticals for human use in all
three ICH regions

6. The purpose of this Common Technical Document
(CTD) is to provide a harmonised structure and
format for new product applications.
The CTD guidance indicates where and how, available
information is to be presented.
The CTD is not intended to indicate what studies are
actually required.

7. CTD STRUCTURE
The CTD is organized into FIVE modules:
Module 1: Regional Administrative Information
Module 2: Common technical document summaries
Module 3: Quality
Module 4: Safety (nonclinical study reports)
Module 5: Efficacy (clinical study reports)

9. MODULE 2: COMMON TECHNICAL
DOCUMENT SUMMARIES
Module 2 summarises the information that will be provided in the quality
(Module 3), nonclinical (Module 4) and clinical (Module 5) modules of
the dossier.
There is no single document that explains the content of Module 2 for the
registration of pharmaceuticals for human use.
The documents for Modules 3, 4, and 5 include a section on the
information that must be provided in Module 2.

11. MODULE 3: QUALITY
Module 3 describes the format and organisation of
the chemical, pharmaceutical and biological data
relevant to the application.

12. MODULE 4: SAFETY (NONCLINICAL
STUDY REPORTS)
Module 4 describes the format and organisation
of the nonclinical (pharmaco-toxicological)
data relevant to the application.

13. MODULE 5: EFFICACY (CLINICAL
STUDY REPORTS)
Module 5 describes the format and organisation of the
clinical data relevant to the application.

15. After 6 months of CTD acceptance, in May 2001 eCTD was agreed
by Multidisciplinary 2, Expert Working Group (ICH M2 EWG).
It is maintained by eCTD Implementation Working group (IWG)
in accordance with the ICH Process.
The eCTD is defined as „an interface for industry to agency transfer
of regulatory information while at the same time taking into
consideration the facilitation of the creation, review, lifecycle
management and archival of the electronic submission’.

16. 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.

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

18. CHARACTERISTICS OF ECTD
1. Files Referenced in the XML Backbone
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

19. 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

20.  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
Benefits of eCTD

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

24. 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

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