CTD A Regulatory Document

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

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

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 Introduction2.3: Quality Overall Summary 2.4: Nonclinical overview2.5: Clinical Overview2.6: Nonclinical Written and Tabulated Summaries (covers

pharmacology, pharmacokinetics, and toxicology)2.7: Clinical Summary (covers clinical efficacy, clinical safety

etc.)

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 33.2: Body of Data (covers drug substance, drug product,

appendices, and regional information)3.3: Literature References

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 44.2: Study reports4.3: Literature References

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

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

Thank You