Introduction to CTD and eCTD submissions

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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