ICH CTD
Module 1: Administrative
Information and Prescribing
Information.
Document Summaries
2.1 Common Technical Document
Table of Contents (Modules 2-5)
2.2 CTD Introduction
2.3 Quality Overall Summary
2.4 Nonclinical Overview
and
Pharmacology
Pharmacokinetics
Toxicology
2.7 Clinical Summary
BiopharmaceuticStudies
and
Associated Analytical Methods
Clinical Pharmacology Studies
Clinical Efficacy
Clinical Safety
Literature References
Synopses of Individual Studies
PART-3;NON
CLINICAL/SAFETY
DOCUMENT
S-A-ToC
S-B-nonclinical overview
S-C-nonclinical written
tabulations summary
S-D-non clinical study reports
Module 3: Quality
PART-4;CLINICAL/EFFICACY
DOCUMENT
S-A-ToC
S-B-Clinical overview
Reports
S-C-Clinical summary
S-D-Tabular listing of all clinical
studies
S-E-Clinical study reports
S-F-List of key literature
references
Module
Reports
5:
Clinical
Study
SUMMARY;
ICH CTD
All modules except M1 are
a part of CTD
Applicable to
U.S/E.U/JAPAN
ACTD
All the 4parts are a part of
CTD
Applicable to Singapore,
Indonesia, Vietnam,
Malaysia, Philippines,
Thailand ,Myanmar,
Combodia, Brunei
Darussalam
Submitted only upon
request
Quality summary & reports
part2
respectively
Non clinical overview
,summary, tabulations&
reports-2.4,2.6&M4
respectively
clinical overview
,summary, tabulations&
reports-2.5,2.7&M5
Working group began to
work
Q- E.U
S-JAPAN
E- U.S.A
DIAGRAMATIC REPRESENTATION OF
ICH CTD
DIAGRAMATIC REPRESENTATION OF
ACTD