Common Technical Document (CTD) serves as a set of specifications for application dossier for the registration of medicines, and designed to be used across Europe, Japan and the United States. The guidelines for CTD are provided by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). TSDP provides clinical medical writing training on preparation of CTD.

1. CTD
A Regulatory Document

2. COMMON TECHNICAL DOCUMENT (CTD)
 Comprehensive set of specifications for application dossier for
registration of medicines
 Designed to be used across Europe, Japan and the United States
 Internationally acceptable and agreed format for the preparation of
applications for new drugs intended to be submitted to regional
regulatory authorities in the participating countries
 Contains 5 modules: Administrative Information and Prescribing
Information; Common Technical Document Summaries; Quality;
Nonclinical Study Reports; and Clinical Study Reports

3. COMMON TECHNICAL DOCUMENT (CTD)
Module 1: Administrative Information and Prescribing Information
 Contains documents specific to each region
 Documents include application form, summary of product
characteristics, patent certification, labelling text, environmental risk
assessment, description of pharmacovigilance (PV) system, and risk
management plan (RMP)
 This module is not a part of CTD
 Content and format of this module may vary as per relevant regulatory
authorities

4. COMMON TECHNICAL DOCUMENT (CTD)
Module 2: Common Technical Document Summaries
 This module is further divided into:
2.1: CTD 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 (covers
pharmacology, pharmacokinetics, and toxicology)
2.7: Clinical Summary (covers clinical efficacy, clinical safety etc.)

5. COMMON TECHNICAL DOCUMENT (CTD)
Module 3: Quality
 Provides a harmonized structure and format for presenting chemistry,
manufacturing, and controls (CMC) information in registration dossiers
 Described in guidance M4-Q
 Further divided into:
3.1: Table of Contents (TOC) of Module 3
3.2: Body of Data (covers drug substance, drug product,
appendices, and regional information)
3.3: Literature References

6. COMMON TECHNICAL DOCUMENT (CTD)
Module 4 (Nonclinical Study Reports)
 Module 4 includes non-clinical study reports
 Non-clinical study reports must be presented in order described in
guidance M4-S
 Non-clinical study reports include reports related to pharmacology,
pharmacokinetics, toxicology
 The sequence is
4.1: TOC of Module 4
4.2: Study reports
4.3: Literature References

7. COMMON TECHNICAL DOCUMENT (CTD)
Module 5 (Clinical Study Reports)
 Module 5 includes clinical study reports
 Clinical (human study) reports must be presented in order described in
the guidance M4-E
 Clinical study reports include reports of biopharmaceutical studies,
pharmacokinetics, pharmacodynamics, efficacy and safety, and post-
marketing experience studies
 The sequence is
 5.1: TOC of Module 5
 5.2: Tabular listing of clinical studies
 5.3: Study reports
 5.4: Literature References

8. COMMON TECHNICAL DOCUMENT (CTD)
• Electronic version of CTD is known as eCTD
• eCTD is highly recommended by USFDA for NDAs, BLAs, DMFs, and
INDs filings
• Common format for submission of marketing authorization applications
across 3 ICH regions: Europe, Japan, and the USA
• Enables pharmaceutical companies to make simultaneous filings in
ICH regions by eliminating the extensive work previously required to
convert dossier off one region to another region or vice versa

9. Thank You