The Common Technical Document (CTD) is a standardized format for new drug applications agreed upon by international regulatory agencies. It has 5 modules covering administrative information, summaries, quality, non-clinical studies, and clinical studies. The electronic CTD (eCTD) is the electronic version that regulatory agencies now require. eCTD submissions have granular documents linked by XML and allow for increased transparency, ease of review, and benefits like reduced submission time and costs.

1. CTD and eCTD
Girish Swami, (M.Pharm, PGDIPR, PGDDRA)
International Regulatory Affairs Dept.
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+91-9881492626
pr.girish@gmail.com

2. What is CTD/eCTD ?
Common Technical Document (CTD): Its an
format set by ICH which was agreed by the
Regulatory Agencies of Europe, Japan & the US.
Its electronic version called as
electronic Common Technical Document
(eCTD).
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3. The CTD Triangle
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4. CTD Modules
Module 1 – Administrative Information
(Region Specific)
Module 2 – CTD Summaries (QOS)
Module 3 – Quality (CMC)
Module 4 – Non-Clinical Study Reports
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Module 5 – Clinical Study Reports
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5. Module 1
Administrative Information (Region Specific)
Should contain documents specific to each region
For USA For EU
Application form 356h Application form
Proposed l b l
d label Summary of product characteristics
Patent certification / Labelling text and mock-ups
information Information about the experts
Debarment certificate
Environmental risk assessment
Letter of Authorization
(LoA)/ DMF letter Description of the
pharmacovigilance system
Labeling text
Risk management plan
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6. Module 2
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CTD Summaries (QOS)
It contain 7 sections in the following order:
2.1 CTD TOC (Module 2-5)
2.2
2 2 CTD Introduction
2.3 Quality Overall Summary
2.4 Non-clinical
2 4 Non clinical Overview
2.5 Clinical Overview
2.6 Non-Clinical
2 6 Non Clinical Summary
2.7 Clinical Summary
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7. Module 3
Quality (CMC)
3.1
3 1 TOC of M d l 3
f Module
3.2 Body of Data
3.2.S - Drug substance
3.2.P - Drug product
3.2.A - Appendices
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3.2.R - Regional Information
3.3
3 3 Literature references
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8. Module 4
Non-Clinical Study Reports
4.1
4 1 TOC of M d l 4
f Module
4.2 Study reports
4.2.1 Pharmacology
4.2.2 Pharmacokinetics
4.2.3 Toxicology
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4.3 Literature References
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9. Module 5
Clinical Study Reports
5.1
5 1 TOC of Module 5
5.2 Tabular listing of Clinical Studies
5.3 Clinical study reports
5.3.1 Reports of Biopharmaceutical (BA-BE) Study
5.3.2 Reports of Pharmacokinetic (biomaterial) study
5.3.3 Reports of Pharmacokinetic (PK) Studies
5.3.4 Reports of Pharmacodynamic (PD) Studies
5.3.5 Reports of Efficacy and Safety studies
5.3.6 Reports of Post-Marketing experience
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5.3.7 Case Report Forms & Individual patient listings
5.4 Literature References
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10. eCTD
Its electronic version of CTD so called as
CTD,
electronic Common Technical Document
(eCTD).
eCTD composed of two types of specification
Content specification – As defined by ICH
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Technical specification – Electronic software's
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11. eCTD is highly recommended by USFDA for
NDAs, BLAs, DMFs and INDs filing
From year 2010 European Union also make
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compulsory for electronic CTD submission to all
procedures
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12. eCTD Characteristics
Structure
All Modules 1 to 5 have granularity
options.
PDF documents linked via XML
backbone
Increased document granularity
granularity.
Transparency of entire submission
Ease of navigation and review
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13. eCTD Template
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14. M1
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15. M2
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16. M3
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17. M4
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18. M5
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19. Benefits of eCTD
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20. Thank
Th k you
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