Vous êtes sur la page 1sur 6

DIFFERENCES BETWEEN ICH CTD

AND ASEAN CTD


Main differences are the organization of data and
numbering of sections.
Since there are differences in ACTD format among
ASEAN CTD countries, there is flexibility to use ICH
CTD for NCEs and BIOLOGICS VACCINES.
STILL HARMONIZATION PROCESS IS GOING ON TO
DERIVE A COMMON ACTD FORMAT FOR ASEAN
COUNTRIES.
CONTENTS OF ACTD AND ICH CTD
ACTD
PART 1 ToC, Administrative
data, Product information.
Section A-Introduction.
Section B-overall ACTD (ToC).
Section C-Doc. Required for
registration.

ICH CTD
Module 1: Administrative
Information and Prescribing
Information.

PART-2 QUALITY DOCUMENT.


S-A-ToC
S-B-QOS
S-C-body of data

Module 2: Common Technical

1.1 Table of Contents of the


Submission Including Module 1.
1.2 Documents Specific to Each
Region.

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

2.5 Clinical Overview


2.6 Nonclinical Written
Tabulated Summaries

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

Module 4: Nonclinical Study

3.1 Table of Contents of Module 3


3.2 Body of Data
3.3 Literature References

Reports

4.1 Table of Contents of Module 4

S-C-Clinical summary
S-D-Tabular listing of all clinical
studies
S-E-Clinical study reports
S-F-List of key literature
references

4.2 Study Reports


4.3 Literature References

Module

Reports

5:

Clinical

Study

5.1 Table of Contents of Module 5


5.2 Tabular Listing of All Clinical
Studies
5.3 Clinical Study Reports
5.4 Literature References

SUMMARY;
ICH CTD
All modules except M1 are
a part of CTD
Applicable to
U.S/E.U/JAPAN

Non clinical & clinical


study reports are
mandatory
Quality summary &
reports-2.3&M3

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

Non clinical overview


,summary, tabulations&
reports-part3
clinical overview ,summary,
tabulations& reports- part4
Working group began to
work
ACTDQ-INDONESIA
ACTD SAFETY/NONCLINICALPHILLIPPINES
ACTD EFFICACY/CLINICALTHAILAND
OVERALL ACTD
ORGANISATION- THAILAND
GUIDELINES ACTD FRAMED
BY;
Analytical validation Thailand
BABE- Malaysia
Stability- Indonesia
Mfg.process validationSingapore

ICH countries follow CTD


upon M.O.U

ASEAN countries follow


ACTD upon MRA(mutual
recognition arrangement]

DIAGRAMATIC REPRESENTATION OF
ICH CTD

DIAGRAMATIC REPRESENTATION OF
ACTD