PRODUCT REGISTRATION IN THE GLOBAL MARKET WITH CTD

TRAINER: MD. ZAKARIA FARUKI
ORION PHARMA LIMITED
DHAKA, BANGLADESH
Slide 1 of 26
TRAINING ON
PRODUCT REGISTRATION
IN THE GLOBAL MARKET
WITH CTD
ORION

INTERNATIONAL CONFERENCE ON
HARMONIZATION (ICH)
ICH was formed in April 1990 hosted by EFPIA
(European Federation of Pharmaceutical Industries
and Associations) in Brussels, Belgium
ICH-SC (Steering Committee) has decided that the
Topics selected for harmonization would be divided
into Safety, Quality and Efficacy to reflect the three
criteria which are the basis for approving and
authorizing new medicinal products.
In a broad sense harmonization means a common of
technical requirements for medicines regulation, i.e.,
legislations, guidelines, procedures, etc.
Training on CTD Conducted by Md. ZakariaTraining on CTD Conducted by Md. ZakariaTraining on CTD Conducted by Md. ZakariaTraining on CTD Conducted by Md. Zakaria FarukiFarukiFarukiFaruki
Observers
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ORION

WHAT IS CTD?
It is an application format of ICH’s mission is to
make recommendations towards achieving
greater harmonization.
Internationally agreed “well structured common
format” for the organization of the technical
requirements that is to be submitted to the
regulatory authority as an application for the
registration of pharmaceuticals for human use
in all three ICH regions (USA, Europe and
Japan).
Ensure that safe, effective, and high quality
medicines are developed and registered in the
most resource-efficient manner.
Reducing or averting duplication of testing
carried out during the research and
development of new human medicines
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ORION

WHY CTD?
To provide a harmonized format / template for
the submission of technical requirement to the
regulatory authorities (FDA) that is acceptable
in all 3 ICH regions.
Reduce the time and save resources used to
compile applications
Eliminate duplicating of activities
It will ease the preparation of electronic
submissions (eCTD)
Companies have to generate only one data set
for all regions, and consequently the amount of
human and animal experimentation is reduced.
Faster access to medicines of high public health
value.
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ORION

CTD TRIANGLE
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ORION
Pivotal to
Dossier
However, CTD impacts
Labeling

CTD STRUCTURE
CTD contains 5 “Modules”
Module 1 – Administrative & Prescribing
Information
Module 2- All CTD Summaries / Overviews
Module 3 –Quality (M4Q)
Module 4 – Non Clinical Study (M4S)
Module 5 – Clinical Study (M4E)
Module 2-5 are Common in CTD & Module 1 is
Region specific but always to be included in
complete CTD structure.
ORION
Training on CTD Conducted by Md. ZakariaTraining on CTD Conducted by Md. ZakariaTraining on CTD Conducted by Md. ZakariaTraining on CTD Conducted by Md. Zakaria FarukiFarukiFarukiFaruki Slide 6 of 26

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
ORION

2.3 QUALITY OVERALL SUMMARIES
(QOS)
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 (Less than 50 Pages),
excluding tables, figures
ORION

2.4 NONCLINICAL OVERVIEW
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 Citation
Non-clinical data with it’s interpretation
Clinical relevance of findings. Typically 50-400 pages
(excluding tables)
Implications of the findings for the safe use of the
product.
ORION

2.5 CLINICAL OVERVIEW
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
Critical analysis of clinical data for efficacy and
safety, as well as other relevant information.
Typically this section should coved by 30 pages.
ORION

2.6 NONCLINICAL WRITTEN AND
TABULATED SUMMARIES
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
Typically This section consist of 100-150 pages
ORION

2.7 CLINICAL SUMMARY
2.7.1 Summary of biopharmaceutic studies
and associated analytical methods
2.7.2 Summary of clinical pharmacology
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
Detailed summarization of the clinical information in
module 5. Typically 50-400 pages (excluding tables)
Post marketing data for products that have marketed in
other regions to be incorporated.
ORION

MODULE 3: QUALITY
Chemical-pharmaceutical information and
biological information (CMC)
Table of content to direct reviewer around
the document
Provide body of data as follow:
Section S Section P
Section A Section R
Section C
ORION

SUBMISSION OF CMC
INFORMATION IN CTD FORMAT
(Cont’d…)
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
DRUG SUBSTANCE
General Information
Manufacture
Characterization
Control of Drug Substance
Reference Standards or Materials
Container Closure System
Stability
ORION

SUBMISSION OF CMC
INFORMATION IN CTD FORMAT
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
DRUG PRODUCT
Description & Composition of the FPP
Pharmaceutical Development
Manufacture
Control of Excipients
Control of Drug Product
Reference Standards or Materials
Container Closure System
Stability
ORION

APPENDIX, REGIONAL
INFORMATION & LITERATURE
REFERENCES
3.2.A APPENDICES
3.2.A.1 Facilities and Equipments
3.2.A.2 Adventitious Agents safety
evaluation
3.2.A.3 Novel excipients
3.2.R REGIONAL INFORMATION
3.2.R.1 Production documentation
3.2.R.2 Executed production documents
3.2.R.3 Master production documents
3.3 LITERATURE REFERENCES
ORION
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MODULE 4: NON CLINICAL
4.1 TABLE OF CONTENTS
4.2 STUDY REPORTS
4.2.1 Pharmacology
4.2.2 Pharmacokinetics
4.2.3 Toxicology
4.3 LITERATURE REFERENCES
ORION
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Module 5: Clinical Study
5.1 Table of Contents
5.2 Tabular Listing of all Clinical Studies
5.3 Clinical Study Reports
5.3.1 Reports of Biopharmaceutics Studies
5.3.2 Reports of Studies Pertinent to PK using Human Biomaterials
5.3.3 Reports of Human Pharmacokinetic (PK) Studies
5.3.4 Reports of Human Pharmacodynamic 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
ORION
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GUIDANCE FOR THE INDUSTRY
ORION
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ICH STATUS OF
HARMONIZATION INITIATIVE
ORION
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ADVANTAGES OF CTD…
• Provides a Harmonized format for the submission
of information for regulatory authorities
• Harmonized format allowing electronic
transmission
• To save time and resources
• To facilitate regulatory review and
communications
• Easy to understand and evaluation of data
• Networking of institutions in developing and
developed countries is an important element in
building regulatory capacity and trust
ORION
Slide 21 of 26

ADVANTAGES OF CTD
Applicable to all types of products (NCE,
NDA, ANDA, radiopharmaceuticals,
vaccines, herbals, etc.)
Enabled implementation of good review
practices
Facilitation of response to questions
Partially identical data package
No actual increase in EU and / or Japanese
application size/review time
ORION
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LIMITATIONS………
CTD is only a format, its not a single dossier
with a single content.
Legal requirements differ in three regions
ICH guidelines have not yet harmonized in all
requirements
Pharmacopoeias are not harmonized
Applicant may have regional preferences.
No detailed information about content of
dossier
Which studies/data required for a successful
approval
Still not identical for all regions (different
regional requirements)
ORION
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CONCLUSION
Whilst the realization of the CTD took many years,
there is now a common format for the submission
of Marketing Authorizations Applications across
the three ICH regions –
Europe
Japan and
USA
This should facilitate pharmaceutical companies to
make simultaneous filings in the ICH regions as it
will eliminate the extensive work previously
required to convert, for example, a US dossier to
an EU dossier and vice versa.
ORION
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ORION
“Hesitating to act
because the
whole vision
might not be
achieved, or
because other do
not yet share it,
is an attitude that
only hinders
progress.”
‐‐‐‐M. K. Gandhi

ORION

PRODUCT REGISTRATION IN THE GLOBAL MARKET WITH CTD

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