CTD STRUCTURE
Dr Monica Hemben Eimunjeze
Director Registration & Regulatory Affairs
Please note that this presentation should not be copied or distributed without the explicit approval of NAFDAC
• The Common Technical Document is one of the
outputs of the ICH which are known as ICH Topics
• The topics are divided into four categories known
Introduction as Quality, Safety, Efficacy, Multidisciplinary (Q, S,
E, M)
• The CTD is found under the multidisciplinary
topic
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• The CTD for has several advantages
• Harmonised submissions
• Enabled implementation of good review practices
Introduction • Eliminated the need to reformat the information for
submission to the different regulatory authorities
• Complete and well-organized submissions
• More predictable format
• More consistent reviews
Easier analysis across applications
Easier exchange of information
Faster review times for applications
Introduction
Facilitates electronic submission
Accelerate access to affordable and quality-
assured medicines and health commodities
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Module 1
Module 2
Module 3
Module 4
Module 5
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1.0 Cover Letter
1.1 Table of Contents
(Module 1 – 5)
1.2
Application Information
Second Level
1.3 Product Information Folder
(Child)
1.4 Regional Summaries
Module 1 Electronic Review Documents
1.5
1.6 Samples
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1.0
Cover Letter Document should
be searchable
1.1
Table of Contents Module 1 – 5
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1.2.1
1.2 1.2.2 Third Level
Folder
……. (Grandchild)
1.2.18
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1.2.1
Application Letter
In searchable pdf
1.2.2
……. Registration Form
1.2.18
Additional Strength Biowaiver
19 - 21 February 2020
Request Form
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Sub – Folders Under Application Information
(1.2)
• 18 Sub-Folders under 1.2:
• 1.2.1 – Application Letter
• 1.2.2 – Registration Form
• 1.2.3 – Certificate of Incorporation
• 1.2.4 – Power of Attorney
• 1.2.5 – Notarised Declaration of the Applicant
• 1.2.6 – Contract Manufacturing Agreement
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• 1.2.7 – Certificate of Pharmaceutical Product (COPP)
• 1.2.8 – Certificate of Good Manufacturing Practice
• 1.2.9 – Manufacturing Authorisation
• 1.2.10 – Evidence of Trade Mark Registration
• 1.2.11 – Superintendent Pharmacist’s Annual Licence
to Practice
• 1.2.12 – Certificate of Registration and Retention of
Premises
• 1.2.13 – Evidence of Previous Marketing Authorisation
• 1.2.14 – Invitation Letter for GMP Inspection
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• 1.2.15 – Copy of Certificate of Suitability (CEP) where
applicable
• 1.2.16 – Letter of Access for APIMF(s) where applicable
• 1.2.17 – Biowaiver Request in relation to conducting
BCS-based bioavailability study
• 1.2.18 – Biowaiver request in relation to conducting
Additional Strength bioavailability study
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Sub – Folders Under Product Information (1.3)
• 3 Sub-Folders under 1.3:
• 1.3.1 – Summary of Product Characteristics (SmPC)
• 1.3.2 – Labelling (Inner and outer)
• 1.3.3 – Package Insert (also known as Patient Information
Leaflet PIL)
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Sub – Folders Under Regional Summaries (1.4)
• 2 Sub-Folders under 1.4:
• 1.4.1 – Bioequivalence Trial Information Form (BTIF)
• 1.4.2 – Quality Information Summary (QIS
Note: There are no sub-folder for 1.5 and 1.6
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2.1 CTD Table of Contents (Mod. 2 – 5 )
2.2 CTD Introduction
2.3 Quality Overall Summary
2.4 Non-Clinical Overview
2.5 Clinical Overview
Module 2
2.6 Non-Clinical Summary
2.7 Clinical Summary
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3.1 Table of Contents (Module 3)
3.2 Body of Data
Module 3
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3.2.A Appendices
3.2.P Drug Product
3.2
3.2.R Regional Information
Body of Data
3.2.S Drug Substance
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3.2.S.1 General Information
3.2.S.2 Manufacture
3.2.S.3 Characterisation
3.2.S.4 Control of Drug Substance
3.2.S
3.2.S.5 Reference Standards and Materials
Drug Substance
3.2.S.6 Container Closure System
3.2.S.7 Stability
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Sub-Folders under Drug Substance (S.1 – S.7)
• 3 Sub-Folders under 3.2.S.1:
• 3.2.S.1.1 – Nomenclature
• 3.2.S.1.2 – Structure
• 3.2.S.1.3 – General Properties
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• 6 Sub-Folders under 3.2.S.2:
• 3.2.S.2.1 – Manufacturer(s)
• 3.2.S.2.2 – Description of Manufacturing Process and Controls
• 3.2.S.2.3 – Control of Materials
• 3.2.S.2.4 – Control of Critical Steps and Intermediates
• 3.2.S.2.5 – Process Validation and/or Evaluation
• 3.2.S.2.6 – Manufacturing Process Development
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• 2 Sub-Folders under 3.2.S.3:
• 3.2.S.3.1 – Elucidation of Structure and Other
Characteristics
• 3.2.S.3.2 – Impurities
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• 5 Sub-Folders under 3.2.S.4:
• 3.2.S.4.1 – Specification
• 3.2.S.4.2 – Analytical Procedures
• 3.2.S.4.3 – Validation of Analytical Procedures
• 3.2.S.4.4 – Batch Analyses
• 3.2.S.4.5 – Justification of Specification
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• 3 Sub-Folders under 3.2.S.7:
• 3.2.S.7.1 – Stability Summary and Conclusion
• 3.2.S.7.2 – Post Approval Stability Protocol and Stability
Commitment
• 3.2.S.7.3 – Stability Data
Note: There are no sub-folders under 3.2.S.5 and 3.2.S.6
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3.2.P.1 Description and Composition
3.2.P.2 Pharmaceutical Development
3.2.P.3 Manufacture
3.2.P.4 Control of Excipients
3.2.P 3.2.P.5 Control of Drug Product
Drug Product 3.2.P.6 Reference Standards and Materials
3.2.P.7 Container Closure System
3.2.P.8 Stability
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Sub-Folders under Drug Product (P.1 – P.8)
• 5 Sub-Folders under 3.2.P.3:
• 3.2.P.3.1 – Manufacturer(s)
• 3.2.P.3.2 – Batch Formula
• 3.2.P.3.3 – Description of Manufacturing Process and
Process Controls
• 3.2.P.3.4 – Control of Critical Steps and Intermediates
• 3.2.P.3.5 – Process Validation and/or Evaluation
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• 6 Sub-Folders under 3.2.P.4:
• 3.2.P.4.1 – Specifications
• 3.2.P.4.2 – Analytical Procedures
• 3.2.P.4.3 – Validation of Analytical Procedures
• 3.2.P.4.4 – Justification of Specifications
• 3.2.P.4.5 – Excipients of Human or Animal Origin
• 3.2.P.4.6 – Novel Excipients
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• 6 Sub-Folders under 3.2.P.5:
• 3.2.P.5.1 – Specification(s)
• 3.2.P.5.2 – Analytical Procedures
• 3.2.P.5.3 – Validation of Analytical Procedures
• 3.2.P.5.4 – Batch Analyses
• 3.2.P.5.5 – Characterisation of Impurities
• 3.2.P.5.6 – Justification of Specification(s)
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• 3 Sub-Folders under 3.2.P.8:
• 3.2.P.8.1 – Stability Summary and Conclusion
• 3.2.P.8.2 – Post Approval Stability Protocol &
Commitment
• 3.2.P.8.3 – Stability Data
• Note: There are no sub-folders under 3.2.P.1, 3.2.P.2, 3.2.P.6
& 3.2.P.7
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Sub – Folders under Appendices (3.2.A)
• 3 Sub-Folders under 3.2.A:
• 3.2.A.1 – Facilities and Equipment
• 3.2.A.2 – Adventitious Agents Safety Evaluation
• 3.2.A.3 – Novel Excipients
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Sub – Folders Under Regional Information
(3.2.R)
• 2 Sub-Folders under 3.2.R:
• 3.2.R.1 – Production Documentation
• 3.2.R.2 – Analytical Procedures and Validation
Information
• 3.2.R.1 is separated further into:
• 3.2.R.1.1 – Executed Production Documents
• 3.2.R.1.2 – Master Production Documents
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Module 4 – Nonclinical Study Reports
• This section is not applicable to generic products
• Will usually not be provided in the dossier submission
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5.1 CTD Table of Contents for Module 5
5.2 Tabular Listing of All Clinical Studies
Module 5 5.3 Clinical Study Reports
5.4 Literature References
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5.3.1 Biopharmaceutics Study Reports
5.3.2 Pharmacokinetic Studies
Using Human Biomaterials
5.3.3 Human Pharmacokinetic (PK)
Studies
Human Pharmacodynamic (PD)
5.3.4
5.3 Studies
5.3.5
Safety and Efficacy Study
Reports
Reports of Post-Marketing
5.3.6
Expereince
5.3.7 Case Study Report Forms and
Individual Patient Listings
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Sub – Folders under Biopharmaceutics Study
Reports (5.3.1)
• 4 Sub-Folders under 5.3.1:
• 5.3.1.1 – Bioavailability (BA) Reports
• 5.3.1.2 – Comparative BA and Bioequivalence (BE) Study Reports
• 5.3.1.3 – In Vitro – In Vivo Correlation Study Reports
• 5.3.1.4 – Reports of Bioanalytical and Analytical Methods for
Human Studies
Note: There are no sub-folders under section 5.3.7.
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