REGULATORY REQUIREMENT

ON DOSSIER OF MEDICINAL

PRODUCTS

Common Technical Document (CTD – ICH)

Quality Overall Summary (QOS)

OUTLINE

AN OVERVIEW OF THE CTD

The CTD is not a “Global Dossier” !

It is an agreed-upon common format for the

“modular” presentation of summaries, reports

and data

Incorporates relevant ICH guidelines

It is organized into five sections:

All “modules” harmonized except Module 1 –

regional specific

Raw data per regional requirements

Result was the CTD Triangle

Module 1

Regional

Administrative

Information

Nonclinical

OverviewQuality

Overall

Summary Clinical

Summary

Module 3

Quality

Module 4

Nonclinical

Study Reports

Module 5

Clinical

Study Reports

Clinical

Overview

Nonclinical

Summaries

Not Part

of CTD

CTD

Module 2

NDS

CTD Structure

Full dossier contains 5 “Modules” - -

- Only Modules 2-5 are “CTD”

Module 1 – region-specific but always included in complete CTD structure

Module 2- All summaries / overviews

Module 3 – CMC (“Quality”)

Module 4 – Preclinical

Module 5 - Clinical

Module 2 - CTD Summaries

2.1 Overall CTD TOC

2.2 CTD Introduction

2.3 Quality Overall Summary

2.4 Non-Clinical Overview

2.5 Clinical Overview

2.6 Non-Clinical Written and Tabulated Summaries

2.7 Clinical Summary

2.2 CTD Introduction

General introduction to the pharmaceutical, including

Pharmacologic class

Mode of action

Proposed clinical use

Typically 1 page

2.3 QUALITY OVERALL SUMMARY -CONTENT

A Summary that follows the scope and

outline of the Body of Data in Module 3

Emphasize and discuss critical key

parameters of the product

Discuss key issues to integrate information

from Module 3 and other modules

Typically 40 pages, excluding tables, figures

2.3 QUALITY OVERALL

SUMMARY - FORMAT

2.3 Introduction

2.3.S Drug Substance

2.3.P Drug Product

2.3.A Appendices

2.3.R Regional Information

2.4 Nonclinical Overview - Content

An integrated and critical assessment of the pharmacologic, pharmacokinetic, and toxicological evaluation

Discuss relevant guidance; any deviations from guidance should be discussed and justified

Nonclinical testing strategy should be justified, including GLP status of submitted studies

Discuss associations with quality characteristics, clinical trial results, effects with related products

Typically 30 pages

2.4 NONCLINICAL OVERVIEW -

FORMAT

2.4.1 Overview of Nonclinical Testing

Strategy

2.4.2 Pharmacology

2.4.3 Pharmacokinetics

2.4.4 Toxicology

2.4.5 Integrated Overview and

Conclusions

2.4.6 List of Literature Citations

2.5 CLINICAL OVERVIEW - FORMAT

2.5.1 Product development rationale

2.5.2 Overview of Biopharmaceutics

2.5.3 Overview of Clinical

Pharmacology

2.5.4 Overview of Efficacy

2.5.5 Overview of Safety

2.5.6 Benefits and Risks Conclusions

2.5.7 References

2.6 NONCLINICAL WRITTEN AND

TABULATED SUMMARIES - FORMAT

2.6.1 Introduction

2.6.2 Written Summary of Pharmacology

2.6.3 Tabulated Summary of Pharmacology

2.6.4 Written Summary of Pharmacokinetics

2.6.5 Tabulated Summary of

Pharmacokinetics

2.6.6 Written Summary of Toxicology

2.6.7 Tabulated Summary of Toxicology

2.7 CLINICAL SUMMARY - FORMAT

2.7.1 Summary of biopharmaceutic studies and

associated analytical methods

2.7.2 Summary of clinical pharmacology

(including clin micro characterization

studies)

2.7.3 Summary of clinical efficacy

2.7.4 Summary of clinical safety

2.7.5 References

2.7.6 Synopses of individual studies

BENEFITS OF THE CTD

More “reviewable” applications

Complete, well-organized submissions

More predictable format

More consistent reviews

Easier analysis across applications

Easier exchange of information

Facilitates electronic submissions