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ICH CTD Seminar

The document discusses the Common Technical Document (CTD) format and electronic CTD (eCTD) submission standards. It provides an overview of the CTD structure and modules. It also outlines the history and implementation of the eCTD standard, current challenges, and plans for future versions. The eCTD aims to provide a common electronic format for regulatory submissions across regions to improve access, reuse of data, and life cycle management of drug applications.

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479 views27 pages

ICH CTD Seminar

The document discusses the Common Technical Document (CTD) format and electronic CTD (eCTD) submission standards. It provides an overview of the CTD structure and modules. It also outlines the history and implementation of the eCTD standard, current challenges, and plans for future versions. The eCTD aims to provide a common electronic format for regulatory submissions across regions to improve access, reuse of data, and life cycle management of drug applications.

Uploaded by

Sin Poul
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
You are on page 1/ 27

DEPARTMENT OF PHARMACEUTICS

REGULATORY AFFAIRS

ICH
CTD
S.Neelima

By

Reddy
M.Pharm 1st

CONTENTS
CTD

INTRODUCTION
IMPLEMENTATION DATES
SCOPE OF C T D
OVERALL TABLE OF CONTENTS
NUMBERING SYSTEM

ectd

SCOPE
HISTORY
CHALLENGES
FUTURE

WHAT IS CTD???

The Common Technical Document (CTD) is a set of


specification for application dossier for the registration of
Medicines and designed to be used across Europe, Japan and
the United States.

It was developed by the European Medicines Agency (EMA,


Europe), the Food and Drug Administration (FDA, U.S.) and
the Ministry of Health, Labour and Welfare (Japan).

The CTD is maintained by the


International Conference on Harmonisation of Technical Requir
ements for Registration of Pharmaceuticals for
Human Use (ICH).
3

IMPLEMENTATION DATES
OF CTD

Optional
July 2001: EU, FDA, MHLW
(Canada, Switzerland)
Mandatory
July 2003: EU, MHLW
(Canada, Switzerland)
Highly recommended
July 2003: FDA

SCOPE OF CTD
Type of Drug
Product

EU

FDA

MHLW

New chemical
entities

included

included

included

New Biologic

included

included

included

New Indication

included

included

included

New Dosage form

included

included

included

New Route of
administration

included

included

included

Generics

included

included

Not included

OTC

included

included

Not included
5

1.0 Regional Administrative Information

Module 1

1.1 ToC of Module 1 or overall ToC,


including Module 1

1.0

2.1 ToC of the CTD (Mod 2,3,4,5)


2.2 Introduction

2.1
Module 2

2.3 Quality Overall Summary

2.2

2.4 Nonclinical Overview


2.4

2.5

2.3
2.6
Module 3
Quality

Module 4

2.5 Clinical Overview

2.7

2.6 Nonclinical Written and


Tabulated Summaries

Module 5

2.7 Clinical Summary

Clinical
Nonclinical
Study Reports Study Reports
6

2.1
ToC of the CTD
(Mod 2,3,4,5)

2.3

Module 3

3.1
ToC for Module 3

Module 1

2.1

2.2

2.4

2.6

1.1
ToC of Module 1
or overall ToC,
including Module 1

Module 4

4.1
ToC for Module 4

2.5

Module 2

2.7
Module 5
5.1
ToC for Module 5

STRUCTURE OF CTD

Module 2
2.1
2.2
2.3
2.3.S
2.3.S.1
2.3.S.2
2.3.S.3
2.3.S.4
2.3.S.5
2.3.S.6

OVERALL CTD TABLE OF CONTENTS OF MODULES 2, 3, 4, AND 5


INTRODUCTION
QUALITY OVERALL SUMMARY
DRUG SUBSTANCE
General Information
Manufacture
Characterization
Control of Drug Substance
Reference Standards or Materials
Container Closure System

2.3.S.7
2.3.P
2.3.P.1
2.3.P.2
2.3.P.3
2.3.P.4
2.3.P.5
2.3.P.6
2.3.P.7
2.3.P.8

Stability
DRUG PRODUCT
Description and Composition of the Drug Product
Pharmaceutical Development
Manufacture
Control of Excipients
Control of Drug Product
Reference Standards or Materials
Container Closure System
Stability
8

Module 2 (Cont.)
2.6
2.6.1
2.6.2
2.6.3
2.6.4
2.6.5
2.6.6
2.6.7
2.7
2.7.1
2.7.2
2.7.3
2.7.4
2.7.5
2.7.6

CONTENT OF NONCLINICAL WRITTEN AND


TABULATED SUMMARIES
Introduction
Pharmacology Written Summary
Pharmacology Tabulated Summary
(Appendix B)
Pharmacokinetics Written Summary
Pharmacokinetics Tabulated Summary
(Appendix B)
Toxicology Written Summary
Toxicology Tabulated Summary (Appendix B)
CLINICAL SUMMARY
Summary of Biopharmaceutics and
Associated Analytical Methods
Summary of Clinical Pharmacology Studies
Summary of Clinical Efficacy
Summary of Clinical Safety
References
Synopses of Individual Studies

Module 3
3.1
3.2
3.2.S
3.2.S.1
3.2.S.2
3.2.S.3
3.2.S.4
3.2.S.5
3.2.S.6
3.2.S.7
3.2.P
3.2.P.1
3.2.P.2
3.2.P.3
3.2.P.4
3.2.P.5
3.2.P.6
3.2.P.7
3.2.P.8

MODULE 3 TABLE OF CONTENTS


BODY OF DATA
DRUG SUBSTANCE
General Information
Manufacture
Characterisation
Control of Drug Substance
Reference Standards or Materials
Container Closure System
Stability
DRUG PRODUCT
Description and Composition of the Drug
Product
Pharmaceutical Development
Manufacture
Control of Excipients
Control of Drug Product
Reference Standards or Materials
Container Closure System
Stability

Module 3 (Cont.)
3.2.A
APPENDICES
3.2.A.1 Facilities and Equipment
3.2.A.2 Adventitious Agents Safety Evaluation
3.2.A.3 Novel Excipients
3.2.R REGIONAL INFORMATION
3.3
LITERATURE REFERENCES

10

Module 4
4.1
4.2
4.2.1
4.2.2
4.2.3
4.3

MODULE 4 TABLE OF CONTENTS


STUDY REPORTS
Pharmacology
Pharmacokinetics
Toxicology
LITERATURE REFERENCES

Module 5

5.1
5.2
5.3
5.3.1
5.3.2

MODULE 5 TABLE OF CONTENTS


TABULAR LISTINGS OF ALL CLINICAL STUDIES
CLINICAL STUDY REPORTS
Reports of Biopharmaceutic Studies
Reports of Studies Pertinent to Pharmacokinetics
using Human Biomaterials
5.3.3
Reports of Human Pharmacokinetic (PK) Studies
5.3.4
Reports of Human Pharmacodynamic (PD) Studies
5.3.5
Reports of Efficacy and Safety Studies
5.3.6
Reports of Post-Marketing Experience
5.3.7
Case Report Forms and Individual Patient Listings
5.4
LITERATURE REFERENCES

11

LINE EXTENSIONS, VARIATIONS &


SUPPLEMENTS
EU, FDA & MHLW agreed as follows:
For New products,
new CTD format should be used
For Old products,
cross-reference to old format is acceptable
existing dossier)

(no requirement to reformat

12

13

eCTD

14

INTRODUCTION

In November 2010, the ICH Steering Committee endorsed


the establishment of an Exert Working Group (EWG) /
Implementation Working Group (IWG) for the eCTD
and assigned the topic code "M8". Work in relation to the
eCTD had previously been undertaken by the M2 EWG.

Under the M8 remit is the support of the progression of the


eCTD through the Standards Development
Organisation (SDO) process to develop the eCTD as an
International Standard. This is in accordance with the 2008
Steering Committee decision that the next major version
of the eCTD be developed in collaboration with SDOs, with
development first as a Health Level Seven (HL7) standard,
and then as an International Organization for
Standardization (ISO) standard.
15

eCTD

WHAT IS eCTD?
Electronic Common Technical Document
Common Technical Document Common format for Quality,
Safety, and Efficacy information
Electronic CTD = ectd An interface for industry to agency transfer of
regulatory information
It is composed of:
Directory structure
Content files
XML eCTD instance

Electronic
submission

eCTD

17

SCOPE OF eCTD
CTD scope + Module 1CTD:
Registration applications for new pharmaceuticals (including
biotechnology-derived products)
Module 1: Regional Administrative Information and Prescribing
Information
Regional scope may vary beyond CTD scope
Investigational New Drug,
Drug Master File / Active Substance Master File, and etc.

18

HISTORY
Regional reviewer driven
o1980s :-Early activities in US in 1980s
o1990s : -Computer Aided New Drug Application (CANDAs)-eNDA Guideline-DAMOS in Germany,
MANSEV in France

Harmonization
o1997:-M2 EWG start working closely with M4 (CTD)
o2003 : -ICH eCTD Guideline v3.0

Implementation
o2004 : -ICH eCTD Guideline v3.2 implemented in all ICH regions
o2008 : -ICH eCTD Guideline v3.2.2-All electronic submissions must be in eCTD format in US
o2010 :-Mandatory eCTD for the Centralised Procedure in EU.

19

WHY eCTD?
Expectation
oHigh availability
oEasy view / navigation
oFast retrieval
oLifecycle support
oLess paper

Results
oExpected advantages have been met.
oContribute to improvement of:Data quality

Reusability

Faster access

Life cycle management


oSome challenges found.

20

CHALLENGES
Advantages sometimes perceived as
disadvantages
Granularity
PDFs
Hyperlinks

Requires tools and trained technical experts


Different implementation approach
Regional rules vary
Changes in way of working
Last minute changes not easy

21

FUTURE
eCTD v4.0

Development by SDO process (HL7 ISO/CEN ICH)


Plan
Step 2 in 2013
Development depends on schedule of SDOs (HL7, ISO, CEN)

Specification
HL7 RPS (Regulated Product Submission) will be used for
message
exchange
ICH M4 CTD and Granularity Document will remain as dossier
structure
PDF will remain as major document format

22

eCTD v4.0
Benefits
1. Broader scope and standardization
2. Interoperability
Challenges
3. Need to understand HL7 process / methodology
4. Will require new tools
5. Regional requirements in the scope of SDO standardization

23

SDO- Standards Development Organisation

24

REFERENCES

http://www.ich.org/products/guidelines/multidisciplinary/arti
cle/multidisciplinary-guidelines.html

CTD : ICH www.ich.org/products/ctd.html

www.google.com

25

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