CTD for B. pharmacy And M. pharmacy

1. K.E SOCIETY
Rajarambapu College of Pharmacy
Kasegaon
Common Technical Documents (CTD)
Presented by – Ankita Avinash Gadekar.
1st Year M.pharm (Pharmcutics)
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Common Technical Document

2. Will Discuss About-
• What is CTD?
• Evolution of CTD
• Why CTD?
• CTD Triangle
• Modules of CTD
• Advantages and Disadvantages of CTD
• Comparing CTD and eCTD
• Conclusion
• References
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3. CTD
• It is a Application Format.
• CTD is a Joint effort of 3 Regulatory Agencies
1.European Medicines Agency (Europe)
2.Food and Drug Administration (FDA, USA) and
3.Ministry of Health, Labour and Welfare(MHLW,Japan)
• CTD is a set of specifications for a dossier for the registration of
medicines (TGA)
• CTD is an internationally agreed “well Structured common format”
for the organization of the technical requirements that is to be
submitted to the regulatory authority as an application for the
registration of pharmacuticals for human use in all three ICH regions.
(USA, Europe, and Japan).
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4. Evolution of CTD
• In ICH region
• 1995- Concept of CTD proposed by Industry.
• November 2000 – ICH CTD guideline finalized.
• September 2002- Guideline re-edited with Numbering and section
Header Changes.
• July 2003 – Voluntary submission phase in three ICH Region.
• 1 July 2003 – Mandatory Requirement in three ICH Regions.
• In India
• 2009 – CDSCO adopt CTD format for technical requirements for
registration of biological products.
• October 28,2010 – CDSCo gives guidelines for feedback purpose for
industry on preparation of CTD for Import/manufacture and
marketing approval of new drug for human use and ask for Comments
and suggestion within 60 days.
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5. Why CTD ?
• The primary objective of the ICH is to avoid duplicative animal
and human testing and to reach a common understanding of the
technical requirements to support the registration process in the
three ICH region.
• Maintaining safeguards on quality, safety, and efficacy and
regulatory obligations to protect public health. With the
development of the CTD, the ICH hopes to accomplish many of
its objectives.
• Reduce the time and resources used to compile application.
• It will ease the preparation of electronic submission.
• To facilitate simultaneous submission in three regions.
• To facilitate easier exchange of regulatory information and there
by ensure faster availability of new medicines.
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6. CTD Triangle
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7. Modules of CTD
• CTD is Divided into five modules.
1) Administrative and prescribing Information
2) Overview and Summary of modules 3 to 5.
3) Quality (Pharmacutical Documentation)
4) Safety(Toxicology Studies)
5) Efficacy(Clinical Studies)
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8. Module1
Administrative and prescribing Information
• Module 1 is for administrative information and prescribing
information and should contain documents that are specific to
each region.
• Administrative Information
 Brief introduction about the applicant company
 Legal and critical Documents such as copy of clinical
Trial/BE., No objection letters issued by CDSCO, Batch
release certificate issued by national regulatory Authorities
• General information on Drug Product
• Regulatory Status in Other Countries
• Information regarding involvement of experts,if any
• Samples of drug materials 8
Common Technical Document

9. Module 2- CTD Summaries
Module No Contents
2.1 Table of content
2.2 Introduction
2.3 Quality overall summaries
2.4 Non-clinical Overview
2.5 clinical Overview
2.6 Nonclinical Summary
2.7 Clinical Summary
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•Module 2 summarises the information that will be provided in the
quality (module 3), nonclinical (module 4) and clinical (module 5)
modules of the dossier.
•The documents for Modules 3, 4, 5 include a section on the
information that must be provided in module 2.
•It is consist of 7 sub-modules.

10. 2.3 Quality Overall Summaries
• The Quality Overall Summary (QOS) is an outline of data
presented in module 3.
• 2.3.S Summary of Drug Substance
• 2.3.P Summary of Drug Product
2.4 Non – Clinical Overview
• 2.4.1 Introduction and GLP Statements
• 2.4.2 – Overview of the Non clinical Testing Strategy
• 2.4.3 – Pharmacology
• 2.4.4 – Toxicology
• 2.4.5 – Conclusions
• 2.4.6 – List of Literature References
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11. 2.5 Clinical Overview
• Overview of analysis of the clinical data .
• Provide a brief overview of the Clinical findings.
• Analyse the benefits and risks of the medicinal product in its
intended use.
2.6 Non – Clinical Summaries
• Summary of Pharmacokinetic, Pharmacological and toxicology
studies – In – vivo/In-vitro, Species, route and duration.
• Appropriate age and gender related effects.
2.7 Clinical Summaries
• This section is intended to provide a detailed information of the
clinical Trial.
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12. Module 3 - Quality
• It describes the format and organization of the Chemical ,
Pharmaceutical and Biological data relevant to the application.
• It is Contains of 3 sub-modules.
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Module Content
3.1 Table of content
3.2 Body of data
3.3 Literature references

13. 3.2 Body of Data
• 3.2.S Drug Substance(s)
 3.2.S.1 General Information (name , Manufacturer)
 3.2.S.2 Manufacture of drug Substance (name , Manufacturer)
 3.2.S.3 Quality of Drug Substance
 3.2.S.4 Stability of Drug Substance
• 3.2.P Drug Product
 3.2.P.4 Control of Excipients
 3.2.P.5 Control of Drug Product
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14. Module 4 – Non Clinical study Report
• It is describe the format and organisation of the nonclinical
(pharmaco-toxicological) data relevant to the application.
• It contain 3 sub- modules .
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Module Content
4.1 Table of Content
4.2 Study report
4.3 Literature references

15. Module 5 – Clinical study Report
• It is describes the format and organisation of the clinical data
relevant to the application.
• It is Consist of 4 sub – modules.
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Module Content
5.1 Table of Content
5.2 Tabular listing of all clinical study
5.3 Clinical study report
5.4 Literature references

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5.3 Clinical Study reports
5.3.1 Reports of biopharmacutical studies
5.3.2 Reports of studies pertinent to Pharmacokinetics using
human biomaterials.
5.3.3 Reports of human pharmacokinetic (PK) studies.
5.3.4 Reports of human pharmacodynamic (PD) studies.
5.3.5 Reports of efficacy and safety studies.
5.3.6 Reports of Post-marketing experience
5.3.7 Case report forms and individual patient listings.

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 Advantages of CTD
1. To Save time and resources
2. To Facilitate regulatory review and communications.
3. Appropriate format for the data.
4. Easy to understand and evaluation of data.
 Disadvantages of CTD
1. No detailed information about Content of Dossier.
2. Still not identical for all regions (different regional
requirements.

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Comparing CTD and eCTD
CTD eCTD
1.It is paper base Format 1.It is Digital Format
2.CTD is submitted in Hard Copy. 2.eCTD is submitted electronically.
3.CTD requires manual navigation
through physical documents.
3.eCTd allow for electronic
navigation through the document.
4.CTD can only be accessed by
physically handling the document.
4.eCTD can be accessed remotely
through electronic means.
5.CTD not allows for faster and
more efficient review by regulatory
agencies as compared to eCTD.
5. eCTD allows for faster and more
efficient review by regulatory
agencies.

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Conclusion
1.In conclusion, the Common Technical Document (CTD) is a
standardized format for submitting regulatory information for
pharmaceuticals, biologics, and medical devices to regulatory
agencies.
2.The electronic Common Technical Document (eCTD) is a
digital version of the CTD that is submitted electronically. While
the CTD is a paper-based format that requires manual navigation
and physical storage, the eCTD is a digital format that allows for
electronic navigation, remote accessibility, and digital storage.
3.The eCTD also allows for faster and more efficient review by
regulatory agencies. Overall, the adoption of eCTD has
improved the regulatory process for pharmaceuticals, biologics,
and medical devices.

20. References
• Textbook of Pharmacutical Regulatory Science, Sachin. D .
Shinde, Umesh Mahajan, Pee vee Publication.
• Drug Regulatory Affairs by, Swapnil Fernandes
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