The document discusses the Common Technical Document (CTD) and electronic Common Technical Document (eCTD), which are standardized formats for submitting documentation to regulatory authorities for approval of new pharmaceutical drugs. The CTD/eCTD are organized into five modules: Module 1 contains administrative information specific to each region; Modules 2-5 are common across regions, with Module 2 summarizing quality, non-clinical and clinical information, Module 3 covering quality aspects, Module 4 containing non-clinical study reports, and Module 5 detailing clinical study reports. The goal of the eCTD is to facilitate the electronic transfer of drug applications and reviews between the pharmaceutical industry and regulatory authorities.

1. Presented By:-
Machhi Dhruvi Anilkumar
1st Sem. M.Pharm.
Department of Pharmaceutical Quality Assurance
Smt. B. N. B. Swaminarayan Pharmacy College, Salvav-vapi
Topic:- CTD (Common Technical Document) &
eCTD (Electronic Common Technical Document)
Subject Name:- Quality Control & Quality Assurance
Subject Code:- MQA103T
1

2. Common Technical Document (CTD)
• The common technical document (CTD) is a set of specification for application
dossier for the registration of medicines & designed to be used across Europe,
Japan & United States.
• It is an internationally agreed format for the preparation of applications regarding
new drugs intended to be submitted to regional regulatory authorities in
participating countries.
• CTD is maintained by ICH of technical requirement for registration of
pharmaceutical for human use.
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3. Electronic common technical document (eCTD)
• Electronic version of CTD is called eCTD.
• After decades of using paper, the goal is the electronic transfer of drug
application & their review across submission formats, procedures &
reasons came in Electronic Common Technical Document (ECTD).
• The eCTD is an interface & international specification for the
pharmaceutical industry to transfer regulatory information.
• The focus of the specification is to provide the ability to transfer the
registration application electronically from industry to a regulatory
authority.
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4. Organization of CTD and eCTD
• The Common Technical Document is organized into five modules.
• Module 1 is region specific.
• Modules 2, 3, 4, & 5 are intended to be common for all regions.
• Conformance with this guideline should ensure that these four
modules are provided in a format acceptable to the regulatory
authorities

5. CTD Triangle

6. Module 1-Administrative information and
prescribing information
• The name of the folder for module 1 should be m1.
• This module contains administrative information that is unique for
each region.
• Regional guidance will provide the specific instructions on how to
provide the administrative formats & detailed prescribing information.

7. Module 2-Summaries
• The name of the folder for module 2 should be m2.
• This module contains overall summaries of quality, non-clinical &
clinical. The files in this module should be provided as PDF text with
exception of a few embedded images, when needed.
• It starts with a general introduction to the drug, including its
pharmacological class, mode of action, & proposed clinical use.

8. Module 3-Quality
• The name of the folder for module 3 should be M3.
• This module contains Quality aspects of the intended drug or
medicinal product.
• Module 3 presents the chemistry, manufacturing,& controls reports for
the product.
• Full details of what should be included in Module 3 are provided in
the ICH M4Q guideline.

9. Module 4 - nonclinical study reports
• The name of the folder for module 4 should be m4.
• This module contains details of nonclinical studies.
• The structure and content of Module 4 is specified in the ICH M4S
guidelines

10. Module 5-Clinical study reports
• The name of the folder for module 5 should be m5.
• This module contains details of clinical studies.
• The structure and content of Module 5 is specified in the ICH M4E
guidelines,9 which provided a specific placement of clinical study
reports & related information to simplify preparation & review & to
ensure completeness.

11. References
• Jordan, Debbie. "An overview of the Common Technical Document
(CTD) regulatory dossier." Medical Writing 23.2 (2014): 101-105.

12. Thank
you