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CTD and Ectd Format: by Bashaant Kumar Sah, 1 Mpharm Nargund College of Pharmacy
CTD and Ectd Format: by Bashaant Kumar Sah, 1 Mpharm Nargund College of Pharmacy
CTD and Ectd Format: by Bashaant Kumar Sah, 1 Mpharm Nargund College of Pharmacy
FORMAT
By bashaant kumar sah ,1st mpharm
NARGUND COLLEGE OF PHARMACY
CTD
• Common Technical Document [CTD]: It is an
format set by ICH which was agreed by the
Regulatory Agencies of Europe , Japan & the U.S.
• The FDA characterized the CTD as “An
information package of clinical, non clinical ,
manufacturing , technical data in the same
content that would be submitted for registering
new drugs in all 3 ICH regions i.e. U.S,European
Union and Japan
ORGANISATIONS OF CTD:
• It should be organized into 5 modules
- Module 1 – Administrative Information
[Region Specific]
-Module 2 – CTD Summaries[QOS]
-Module 3 – Quality[CMC]
-Module 4 – Non clinical study reports
-Module 5 – Clinical study reports
Module 1
Administrative Information [Region
specific]
• This module should contain documents
specific to each region
• Ex : Application form regarding the
prescribing information, proposed label
• This module is not part of the CTD.
• The content & format of this module can be
specified by the relevant regulatory
authorities.
Module 2
CTD Summaries [QOS]
• It should begin with a general introduction to
the pharmaceutical , including its
pharmacological class , mode of action &
proposed clinical use. i.e. information should
not exceed one page
• It contain 7 sections in the following order:
- 2.1 CTD TOC [Module 2 – 5] [Table Of
Content]
- 2.2 CTD Introduction
- 2.3 Quality Overall Summary
- 2.4 Nonclinical overview
- 2.5 Clinical overview
- 2.6 Non clinical summary
- 2.7 Clinical summary
• The organization of these summaries is
described in 3 separate documents: