CTD is common technical document for submission of dossier and widely accepted format for ease of submission and evaluation purpose. TRS 961, Annex 15, Guidelines on submission of documentation for a multisource (generic) finished product. General format: preparation of product dossiers in common technical document format Objectives of CTD guidelines To significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals To facilitate regulatory reviews and communication with the applicant by a standard document of common elements To simplify the exchange of regulatory information between Regulatory Authorities

1. Common Technical Document
Achyut Bikram Thapa

2. Content
1. Introduction to ICH
2. Basics of CTD
3. M4: CTD guidelines
4. CTD: Module 1
5. CTD: Module 2
6. CTD: Module 3
7. CTD: Module 4
8. CTD: Module 5
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3. ICH
• Harmonization of regulatory requirements was pioneered by the
EC, Europe, in the 1980s
• Formed in 1990 as International Conference on Harmonization with
agreement between regulatory agencies and industry associations
of Europe, Japan and the US- tripartite agreement
• Currently International Council for Harmonization of Technical
Requirements for Pharmaceuticals for Human Use.
• A legal entity under Swiss law from 23 October 2015 as an
international association
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4. ICH
• Evolved to respond to increasingly global developments in the
pharmaceutical sector.
• ICH guidelines are applied by a growing number of regulatory
authorities
• ICH's mission is to achieve greater harmonization worldwide to
ensure that safe, effective and high-quality medicines are
developed, and registered and maintained in the most resource
efficient manner whilst meeting high standards.
• Includes 19 Members and 35 Observers.
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5. ICH Guidelines
ICH guidelines are divided into 4 categories
Q: Quality (14 guidelines)
S: safety (12 guidelines)
E: Efficacy (20 guidelines)
M: Multi disciplinary (14 guidelines)
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6. Q Guidelines
Q1A- Q1F Stability
Q2 Analytical Validation
Q3A-Q3E Impurities
Q4A-Q4B Pharmacopeia
Q5A-Q5E Quality of Biotechnology Products
Q6A-Q6B Specifications
Q7 Good Manufacturing Practices
Q8 Pharmaceutical Development
Q9 Quality Risk Management
Q10 Pharmaceutical Quality System
Q11 Development and Manufacture of Drug Substances
Q12 Lifecycle Management
Q13 Continuous Manufacture of Drug Substance and Drug Products
Q14 Analytical Procedure Development
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7. Basics of CTD
• CTD is common technical document for submission of dossier and widely
accepted format for ease of submission and evaluation purpose.
• TRS 961, Annex 15, Guidelines on submission of documentation for a
multisource (generic) finished product. General format: preparation of
product dossiers in common technical document format
• ASEAN has A-CTD format
• ICH M4 is the CTD guidelines
• May be submitted as printed format as CTD or electronic version as e-CTD
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8. Basics of CTD
• CTD is not a global dossier.
• It is an internationally agreed format for the preparation of applications to
be submitted to regulatory authorities
• The CTD indicates an appropriate format for the data that have been
required in an application
• The CTD-format is applicable for all types of products (new chemical
entities, radiopharmaceuticals, vaccines, herbals etc.)
• Contains 5 modules. All modules are harmonized except module 1-
regional specific
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9. Objectives of CTD guidelines
• To significantly reduce the time and resources needed to
compile applications for registration of human pharmaceuticals
• To facilitate regulatory reviews and communication with the
applicant by a standard document of common elements
• To simplify the exchange of regulatory information between
Regulatory Authorities
9

10. Overview
The CTD is organized into five
modules
Module 1 is region specific
Modules 2, 3, 4 and 5 are intended to
be common for all regions
In July 2003, the CTD became the
mandatory format for new drug
applications in the EU and Japan, and
the strongly recommended format of
choice for NDAs submitted to FDA,
United States
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11. Module 1: Regional Administrative Information
Covers Administrative and Prescribing Information
1.1 Table of Contents of the Submission Including Module 1
1.2 Documents Specific to each Region
CTD - Module 1

12. CTD - Module 1: Regional Administrative
Information
1.0 Cover Letter
1.1 TOC
1.2 Application Information
1.3 Product information
1.4 Regional summaries
1.5 Electronic Review
1.6 Samples
1.2.1 EOI
1.2.2 MA
1.2.3 CEP and LOA
1.2.4 LOA
1.2.5 GMP Certificate
1.2.6 Biowaiver request
1.3.1 SMPC
1.3.2 Labelling
1.3.3. PIL
1.4.1 BTIF (Bioequivalence trial
information form)
1.4.2 QIS

13. Common Technical Document Summaries
2.1 Common Technical Document Table of Contents (Modules 2-5)
2.2 CTD Introduction
2.3 Quality Overall Summary
2.4 Nonclinical Overview
2.5 Clinical Overview
2.6 Nonclinical Written and Tabulated Summaries
2.7 Clinical Summary
CTD: Module 2

14. CTD - Module 2: Quality Overall Summary
2.1 TOC
2.2 CTD Introduction
2.3 QOS
2.4 Nonclinical overview
2.5 Clinical overview
2.6 Nonclinical summary
2.7 Clinical summary
QOS_PD

15. • A summary that follows the scope and outline of the body of data in Module 3
• Should not include information that was included in Module 3
• Emphasize and discuss critical key parameter of the product
• Discuss key issues to integrate information from Module 3 and other modules
• Typically, 40 pages, excluding tables and figures
CTD: Module 2.3 QOS

16. • 2.3 Introduction
• 2.3.S Drug Substance (2.3.S1- S.7)
• 2.3.P Drug Product (2.3.P.1-P.8)
• 2.3.A Appendices (2.3.A.1-A.3)
• 2.3.R Regional information
CTD: Module 2.3 QOS Format

17. CTD - Module
2.3: QOS Format
2.3 S 1-7
2.3 P 1-8
2.3 A
2.3 R 1-2
S.1 General information
S.2 Manufacture
S.3 Characterization
S.4 Control of the API
S.5 Reference Standard
S.6 Container Closure system
S.7 Stability
P.1 Description of Composition
P.2 Pharmaceutical
Development
P.3 Manufacture
P.4 Control of excipients
P.5 Control of FPP
P.6 Reference Standard
P.7 Container Closure system
P.8 Stability
A.1
A.2
2.3 S
2.3 A
2.3 P

18. Module 3 : Quality
3.1. Table of contents of module 3
3.2. Body of data
3.2.S Drug substance (name, manufacturer)
3.2.P Drug product (name, dosage form)
3.2.A Appendices
3.2.R Regional information
3.3 Literature references
CTD: Module 3

19. 3.2.S
3.2.S Drug substance (name, manufacturer)
3.2.S.1 General Information (name, manufacturer)
3.2.S.2 Manufacture (name, manufacturer)
3.2.S.3 Characterization (name, manufacturer)
3.2.S.4 Control of Drug Substance (name, manufacturer)
3.2.S.5 Reference Standards or Materials (name, manufacturer)
3.2.S.6 Container Closure System (name, manufacturer)
3.2.S.7 Stability (name, manufacturer)
CTD: Module 3

20. CTD - Module 3.2.S: Drug Substance
3.2.S.1 General information
3.2.S.2 Manufacturer
3.2.S.3 Characterization
3.2.S.4 Control of the API
3.2.S.5 Reference standard
3.2.S.6 Container closure system
3.2.S.7 Stability
3.1 TOC
3.2 Body of data
3.2 S (Drug substance)
3.2 P (Drug Product)
3.2 A (Appendix)
3.2 R (Regional information)
3.3 Literature reference
3.2 S
DMF/APIMF

21. 3.2.P
3.2.P DRUG PRODUCT (NAME, DOSAGE FORM)
3.2.P.1 Description and Composition of the Drug Product (name, dosage form)
3.2.P.2 Pharmaceutical Development (name, dosage form)
3.2.P.3 Manufacture (name, dosage form)
3.2.P.4 Control of Excipients (name, dosage form)
3.2.P.5 Control of Drug Product (name, dosage form)
3.2.P.6 Reference Standards or Materials (name, dosage form)
3.2.P.7 Container Closure System (name, dosage form)
3.2.P.8 Stability (name, dosage form)
3.2.A APPENDICES
3.2.R REGIONAL INFORMATION
CTD: Module 3.2.P: Drug Product

22. CTD - Module 3.2.P Drug
Product
3.2.P.1 Description of composition
3.2.P.2 Pharmaceutical development
3.2.P.3 Manufacturer
3.2.P.4 Control of excipients
3.2.P.5 Control of FPP
3.2.P.6 Reference standard
3.2.P.7 Container closure system
3.2.P.8 Stability
3.1 TOC
3.2 Body of data
3.2 S (Drug substance)
3.2 P (Drug Product)
3.2 A (Appendix)
3.2 R (Regional information)
3.3 Literature reference
3.2 P

23. CTD - Module 3.2.P Drug
Product
P.2.1 Components
P.2.2 FPP
P.2.3 Manufacturing Process Dev
P.2.4 Container Closure System
P.2.5 Microbiological attributes
P.2.6 Compatibility
3.2.P.1 Description of composition
3.2.P.2 Pharmaceutical development
3.2.P.3 Manufacturer
3.2.P.4 Control of excipients
3.2.P.5 Control of FPP
3.2.P.6 Reference standard
3.2.P.7 Container closure system
3.2.P.8 Stability
3.2 P
P.3.1 Manufacturer(s)
P.3.2 Batch formula
P.3.3 Description of mfg. process
P.3.4 Control of critical steps and
intermediate
P.3.5 Process validation and evaluation
P.4.1Specifications
P.4.2 Analytical procedure
P.4.3 Validation of analytical procedure
P.4.4 Justification of specification
P.4.5 Excipients of human or animal origin
P.4.6 Novel excipients

24. CTD - Module 3.2.P Drug
Product
3.2.P.1 Description of composition
3.2.P.2 Pharmaceutical development
3.2.P.3 Manufacturer
3.2.P.4 Control of excipients
3.2.P.5 Control of FPP
3.2.P.6 Reference standard
3.2.P.7 Container closure system
3.2.P.8 Stability
3.2 P
P.8.1Stability Summary and conclusion
P.8.2 Stability protocol and commitment
P.8.3 Stability data
P.5.1 Specification
P.5.2 Analytical procedure
P.5.3 Validation of analytical procedure
P.5.4 Batch analysis
P.5.5 Characterization of impurities
P.5.6 Justification of specifications

25. Module 4: Nonclinical study reports:
Not applicable for multisource products
4.1 Table of Contents of Module 4
4.2 Study Reports
Module 5: Clinical study reports
CTD: Module 4 and 5