COMMON TECHNICAL DOCUMENT

(CTD)

1
Dr. Sukanta
Sen
MBBS, DNB, MD,
MNAMS
Dept. of Clinical &
If you want to go fast go
alone.
If you want to go far go
together. African
Proverb

2
 WILL DISCUSS ABOUT :-
 What is CTD?
 Evolution of CTD

 Why CTD?

 Preparing and organizing the CTD

 What is the current status of CTD?

 ICH – eCTD

 Advantages of CTD

 Limitations

 Benefits

 Conclusion
 References
3
 ABBREVIATIONS
 CDSCO: Central Drugs Standard Control Organization
 CTD: Common Technical Document

 DCGI: Drug Controller General of India

 eCTD: Electronic Common Technical Document

 FDA: Food and Drug Administration

 ICH: International Conference on Harmonisation

 IND: Investigational New Drug application

 NDA: New Drug Application

 USFDA: US Food and Drug Administration

 TGA: Therapeutic Goods Administration

 EMA: European Medicines Agency

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 Substantial documentation and data are required in
submissions for import/manufacture and marketing approval of
drugs for human use, resulting in large, complex applications.
 Till date, applicants have used many different approaches in
organizing the information and the differences in organization of
data in each application has made reviewing more difficult and
can also lead to omission of critical data or analyses.
 Such omissions can result in unnecessary delays in approvals.
Thus, a common format of submission will help in
overcoming these hurdles.

5
 WHAT IS CTD?
 Application format
 The CTD is a set of specifications for a dossier for the
registration of medicines (TGA)
 CTD is an 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
(U.S.A., Europe and Japan).
regions 6
7
 Prior to the advent of the CTD, regulatory reviewers
received
anengaged
application from
in its one company and spent a year or more
review.
When the review was completed, reviewers received the next

application—most likely in a different format—and had to

learn the structure of the new application.
1996- Industry proposed CTD but ICH regulators were hesitant

disruptive to the review process

Regulators asked industry to do a feasibility study.

That study, conducted in May 1996, evaluated the time it took
to convert an FDA new drug application into an European
Medicines Agency (EMA) submission, and the reverse.
8
Regulators quickly saw the potential value of harmonizing
submission formats.
9
 ORIGIN OF CTD…

ICH

WAS OFFICIALLY SIGNED

OFF IN NOVEMBER 2000,

AT 10TH ANNIVERSERY of ICH

;
CTD SAN DIEGO,CALIFORNIA.

10
 CTD

CTD IS A JOINT EFFORT OF 3 REGULATORY AGENCIES:

•European Medicines Agency (EMEA, Europe),

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•Food and Drug Administration (FDA, USA) and

•Ministry of Health, Labour and Welfare (MHLW,Japan).

CTD is maintained by ICH through EWG.

In July 2003, the CTD became the mandatory format for new
drug applications in the EU and Japan, and the strongly
recommended format of choice for NDAs submitted to the FDA.
It has been adopted by several other countries including Australia,
Canada and Switzerland (2004).
 Any guideline which is given by ICH passes through
different
steps.
These different steps are called STATUS of that

GUIDELINE.
Status of CTD

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STATUS FUNCTIONALITY
STEP 4 STATUS ACHIEVED IN
Step 1 Development of Consensus
NOV.2000 IN 5TH ICH CONFERENCE
Step 2 IN SANDIEGO..
Text released for consultation
STEP 5 STATUS ACHIEVED
Step 3 Consultation outside ICH
IN MAY.2001 IN ICH MEETING
Step 4 IN TOKYO.
ICH guideline finalized
GUIDANCE MADE AVAILABLE TO
Step 5 Implementation INDUSTRY IN OCTOBER 16,2001 BY
FDA.
 In 2000, the 10th Anniversary of ICH, Dr. Caroline Nutley
Loew of the Pharmaceutical Research and Manufacturers of
America (PhRMA) wrote a report, The Value and Benefits of
ICH to Industry, which detailed ICH’s creation, procedures, and
guideline development in the areas of safety, efficacy, and
quality.
 Her report anticipated that the CTD would revolutionize the

submission procedures for industry’s regulatory staff.

 Dr. Loew characterized the CTD as “offering potential benefits to
industry far greater than any other single ICH topic,” and
predicted the CTD would afford significant savings in time and
resources as complex multiple submissions were replaced by a
single technical dossier submitted in the three ICH regions—
facilitating simultaneous submission, approval, and launch of
 In calling the CTD “a topic whose value to industry cannot
be underestimated,”
 Dr. Loew noted that with full incorporation of the CTD and
the electronic CTD (eCTD), ICH could turn its sights to
disseminating guideline information to non- ICH countries,
yielding additional benefits to both regulators and industry.
 Ten years later and in anticipation of ICH’s 20th
Anniversary, the value and benefits of ICH to regulators have
been realized.
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 Moreover, implementation of the CTD in 2003 promoted the
involvement of drug regulatory authorities (DRAs) not initially
part of ICH, thereby extending ICH’s harmonized approach.
 The development of the Global Cooperation Group,
which includes representatives from five regional
harmonization initiatives and the newly established
Regulators Forum, created to promote participation by non-
ICH countries interested in implementing ICH’s strategies,
have also helped incorporate the CTD into regulatory
processes, creating a common regulatory language that
promotes faster access to life-saving treatments to patients
15

beyond ICH regions.

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EVOLUTION OF THE
COMMON
TECHNICAL DOCUMENT

17
In ICH Region
1995: Concept of CTD proposed by Industry.

November 2000: ICH CTD guideline finalized.

September 2002: Guideline re-edited with Numbering &

Section Header changes.

Prior to July 2003: Voluntary Submission Phase in 3 ICH

Region.
July 1, 2003: Mandatory Requirement in Three ICH Regions.

In India
2009: CDSCO Adopt CTD format for Technical requirements

for registration of biological products.

October 28, 2010: CDSCO give guideline for feedback purpose

for Industry on Preparation of CTD for Import/Manufacture and

Marketing Approval of New Drug for Human Use (i.e. 18
NDA) & ask for comments and suggestion within 60 days.
1

9
This guidance is developed by CDSCO based on,
-The ICH Harmonised Tripartite Guideline on “Organisation of
the Common Technical Document for the Registration of
Pharmaceuticals for Human Use”. M4, Step 4 version dated
January 13, 2004, and
-Drugs & Cosmetics Act 1940 and Rules made thereunder.

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21
 OBJECTIVE OF ICH TO PREPARE THE CTD
The primary objective of the ICH is to avoid duplicative
animal and human testing and to reach a common
understanding of the technical requirements to support the
registration process in the three ICH regions.
These objectives are achieved through
harmonized guidelines and result in a more economical
use of human, animal and material resources, as well as the
elimination of unnecessary delays in the global
development and availability of new medicines,
whilst maintaining safeguards on quality, safety and
efficacy, and regulatory obligations to protect public health.
With the development of the Common Technical
Document (CTD), the ICH hopes to accomplish many of its
objectives. 22
 WHY CTD?

 To provide a harmonized common 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 resources used to compile
applications
 It will ease the preparation of electronic submissions.
 To facilitate simultaneous submission in three regions.
 To facilitate exchange of regulatory information.
 Faster availability of new medicines
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 24

Figure 1: The Drug Approval Process: Drug approval involves passing a number of
steps, including preclinical and clinical studies, and later, post-marketing research.
PREPARING &
O RGANIZATION
It is organized into:-
OF
CTD
Module 1: General Information
Module 2: CTD summaries

Module 3: Quality

Module 4: Nonclinical study

reports
Module 5: Clinical study reports
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26
 MODULE 1.
Administrative information and prescribing
information.
Document specific to each region.
E.g. Application form
Proposed label for use in the region

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 MODULE 1: GENERAL INFORMATION
1. Covering letter & comprehensive table of contents (modules 1
to 5)
2. Administrative information
1. Brief introduction about the applicant company
2. Duly filled and signed application in Form 44 and Treasury
Challan
3. Legal and Critical Documents
1. Copy of Clinical Trial/BE. No Objection letters issued by
CDSCO
2. For import and marketing of finished products
a.Copy of drug sale license in Form 20B / 21B
b.Copy of Free Sale Certificate (FSC) and/or Certificate of
Pharmaceutical Products (CPP) issued by the Regulatory
Authority of the country of origin 28
c. Batch release certificate issued by National
Regulatory
Authorities

d. Copy of Form 11 for imported drug product for testing

purpose

1.2.3.3 For manufacture and marketing of finished products

a.Copy of existing manufacturing license in Form 25 / 28 / 26

b.Copy of Form-29

4. Undertaking or Declaration as per Annexure II

5. Certificate of Analysis
29
4. Coordinates related to the application
1.Name, address, telephone, fax, e-mail of applicant of drug
product
2.Name, address, telephone, fax, e-mail of manufacturer of drug substance
3.Name, address, telephone, fax, e-mail of the responsible official
4.Name, address, telephone, fax, e-mail of other manufacturer(s)
involved in the production process
5.Name, designation, address, telephone, fax, e-mail of the official
responsible for releasing batches of drug product
6.Name, address, telephone, fax, e-mail of the authorized agent in India:
(for imported drug products)
7.Name, address, telephone, fax, e-mail of the manufacturing premises
holding Market Authorization of the drug product (for imported drug 30
products)
 1.3 GENERAL INFORMATION ON DRUG PRODUCT
1. A brief description of the drug and the therapeutic
class to which it belongs
2. Non-proprietary name or generic name of drug
3. Composition (As per label claim)
4. Dosage form
5. Strength per dosage unit
6. Dispensing requirements
7. Route of administration
8. Commercial presentation
9. Conditions of storage or conservation
10. Full Prescribing Information (Package insert)
11. Product Labeling: Proposed draft labels and cartons have to be
provided.
12. Summary of the packaging procedures for Indian shipments
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 1.4 SUMMARY OF TESTING PROTOCOL(S) FOR
QUALITY CONTROL TESTING together with a complete
impurity profile and release specifications for the product
should be submitted.
 1.5 Regulatory status in other countries

1. List of countries where proposed drug is Marketed

2. List of countries where proposed drug is Approved for
Marketing
3. List of countries where proposed drug is Approved as IND
4. List of countries where proposed drug is Withdrawn (if any,
with reasons for withdrawal)
5. Details of any restrictions on use, in any country where it is
marketed /approved
32
 1.6 Domestic price of the drug followed in the countries of
 1.7 A brief profile of the manufacturer’s research activity
 1.8 A brief profile of the manufacturer’s business activity
in
domestic as well as global market
 1.9 Information regarding involvement of experts, if any
 1.10 Samples of drug product
 1.11 Promotional materials

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 MODULE 2. CTD SUMMARIES
1. Table of content of module
2
2. Introduction
3. Quality overall summaries
4. Non-clinical overview
5. Clinical overview
6. Non-clinical summaries
7. Clinical summaries
34
Module Content
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 and tabulated summaries
Pharmacology
Pharmacokinetics
Toxicology
2.7 Clinical summary
Biopharmaceutic studies and associated analytical methods
Clinical pharmacology studies
Clinical efficacy
Clinical safety
35
Literature references
Synopses of individual studies
 2.3 QUALITY OVERALL
SUMMARIES
 In general, the Quality Overall Summary (QOS) is an outline of

data presented in Module 3.

 Please do not provide the entire information present in Module
3 corresponding sections, but, provide brief information
picked from relevant sections.
 This QOS normally should not exceed 40 pages of text,
excluding tables and figures.

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2.3.S Summary of drug substance

2.3.S.1 General Information (name, manufacturer)

2.3.S.2 Manufacture (name, manufacturer)

2.3.S.3 Characterisation (name, manufacturer)

2.3.S.4 Control of Drug Substance (name, manufacturer)

5. Reference Standards or Materials (name, manufacturer)

6. Container Closure System (name, manufacturer)

2.3.S.7 Stability (name, manufacturer)

2.3.P SUMMARY OF DRUG PRODUCT

2.3.P.1 Description and Composition of the Drug Product (name, dosage

form) 37
2. harmaceutical Development (name, dosage form)

3. (name, dosage form)

4. Control of Excipients (name, dosage form)

5. Control of Drug Product (name, dosage form)

6. Reference Standards or Materials (name, dosage

form)

7. Container Closure System (name, dosage form)

2.3.P.8 Stability (name, dosage form)

2.3.A appendices 38
 2.4 NON-CLINICAL
OVERVIEW
 Nonclinical overview should present an integrated and critical
assessment of the pharmacologic, pharmacokinetic, and
toxicological evaluation of the pharmaceutical.
 In general, it should address the interpretation of data, the
clinical relevance of findings, cross-linking with quality
aspects of the pharmaceutical, and the implications of
nonclinical findings for the safe use of the pharmaceutical.

39
1. Introduction and GLP statement

A brief introduction about the contents of this section and a

comment on the GLP status of the studies submitted should
be provided

2. Overview of the Non Clinical Testing Strategy

3. Pharmacology

4. Pharmacokinetics

5. Toxicology

6. Integrated Overview and Conclusions

40
2.4.7 List of Literature
References
 2.5 CLINICAL OVERVIEW
Summary and analysis of the clinical data

Provide a brief overview of the clinical findings, including

important limitations (e.g., lack of comparisons with an

especially relevant active comparator, or absence of information

on some patient populations, on pertinent endpoints, or on use in
combination therapy).
Analyse the benefits and risks of the medicinal product in its
intended use based upon the conclusions of the relevant clinical
studies 41
 Address particular efficacy or safety issues encountered in
development, and how they have been evaluated and resolved.
 Explore unresolved issues, explain why they should not be
considered as barriers to approval, and describe plans to
resolve them.
 Explain the basis for important or unusual aspects of the

prescribing information

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 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 Literature References

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 2.6 NON-CLINICAL SUMMARIES

Summary of pharmacokinetic, pharmacological and

toxicology studies – in-vivo/in-vitro, species, route
and duration

Appropriate age and gender related effects

44
 2.6.1 Introduction
 2.6.2 Written Summary of Pharmacology

 2.6.2.1 Brief Summary

 2.6.2.2 Primary Pharmacodynamics

 2.6.2.3 Secondary Pharmacodynamics

 2.6.2.4 Safety Pharmacology - defined as

those studies that investigate the potential undesirable
of
pharmacodynamic
a substance effects
on physiological in relation
functions to
exposure in the therapeutic range and above.
2.6.2.5 Pharmacodynamic Drug Interactions

2.6.2.6 Discussion and Conclusions

2.6.3 Tabulated Summary of Pharmacology

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2.6.4 Written Summary of Pharmacokinetics
2.6.4 Written Summary of Pharmacokinetics
2.6.4.1 Brief Summary
2.6.4.2 Methods of Analysis

2.6.4.3 Absorption

2.6.4.4 Distribution

2.6.4.5 Metabolism

2.6.4.6 Excretion

2.6.4.7 Pharmacokinetic Drug Interactions

2.6.4.8 Other Pharmacokinetic Studies

2.6.4.9 Discussion and Conclusions

2.6.4.10 Tables and Figures

2.6.5 Tabulated Summary of Pharmacokinetics

46
 2.6.6 Written Summary of
Toxicology
 2.6.6.1 Brief Summary

Study type and Route of Species Compound

duration administration Compound administered*

po and iv Rat and mouse Parent drug

Single-dose toxicity
po and iv Rat and mouse Metabolite X
Single-dose toxicity
Repeat-dose toxicity
Rat and dog Parent drug
1 month po
Rat “ “
6 months po
Dog “ “
9 months etc. po

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 2.6.6.2 Single-Dose
 Toxicity
2.6.6.3 Repeat-Dose Toxicity (including supportive
toxicokinetics
evaluation)
 2.6.6.4 Genotoxicity

Studies should be briefly summarised in the following order: in

vitro non-mammalian cell system
in vitro mammalian cell system
in vivo mammalian system (including supportive
toxicokinetics evaluation)
o 2.6.6.5 Carcinogenicity (including supportive toxicokinetics
evaluations)
Short- or medium-term studies
Long-term
 studies
2.6.6.6 Reproductive and Developmental 48

Toxicity
 2.7 CLINICAL SUMMARIES
 This section is intended to provide a detailed, factual
summarization of all of the clinical information in the CTD.
This includes:
 information provided in clinical study reports;
 information obtained from any meta-analyses or other cross-
study analyses for which full reports have been included in
Module 5; and
 post-marketing data for products that have been marketed in
other regions
49
 2.7.1 Summary of Biopharmaceutic Studies and
Associated
Analytical Methods
2.7.1.1 Background and Overview
2.7.1.2 Summary of Results of Individual Studies
2.7.1.3 Comparison and Analyses of Results Across
Studies
2.7.2 Summary of Clinical Pharmacology Studies
2.7.2.1 Background and Overview
2.7.2.2 Summary of Results of Individual Studies
 2.7.2.3 Comparison and Analyses of Results Across
Studies 50

 2.7.2.4 Special Studies

 2.7.3 Summary of Clinical Efficacy
 2.7.3.1 Background and Overview of Clinical Efficacy
 2.7.3.2 Summary of Results of Individual Studies
 2.7.3.3 Comparison and Analyses of Results Across Studies
 2.7.3.3.1 Study Populations
 2.7.3.3.2 Comparison of Efficacy Results of all Studies
 2.7.3.3.3 Comparison of Results in Sub-populations
 2.7.3.4 Analysis of Clinical Information Relevant to
Dosing Recommendations
 2.7.3.5 Persistence of Efficacy and/or Tolerance 51

Effects
 2.7.4.2.1.3 Other S2.7.4 Summary of Clinical Safety
 2.7.4.1 Exposure to the Drug

 2.7.4.1.1 Overall Safety Evaluation Plan and Narratives of Safety Studies

2.7.4.1.2 Overall Extent of Exposure

2.7.4.2 Adverse Events

2.7.4.2.1 Analysis of Adverse Events

2.7.4.2.1.1 Common Adverse Events

 2.7.4.2.1.2 Deaths
erious Adverse Events

2.7.4.2.1.4 Other Significant Adverse Events

2.7.4.2.1.5 Analysis of Adverse Events by Organ System or Syndrome

2.7.4.2.2 Narratives

2.7.4.3 Clinical Laboratory Evaluations

2.7.4.4 Vital Signs, Physical Findings, and Other Observations

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Related to Safety
o 2.7.4.5 Safety in Special Groups and Situations
o 2.7.4.5.3 Drug Interactions
o 2.7.4.5.4 Use in Pregnancy and Lactation
o 2.7.4.5.5 Overdose
o 2.7.4.5.6 Drug Abuse

o 2.7.4.5.7 Withdrawal and Rebound

o 2.7.4.5.8 Effects on Ability to Drive or Operate Machinery

or
Impairment of Mental Ability
 2.7.4.6 Post-marketing Data
 2.7.5 Literature References
53
 2.7.6 Synopses of Individual Studies
 MODULE 3 QUALITY
The Quality section of the Common Technical Document
(M4Q) provides a harmonised structure and format for
presenting CMC (Chemistry, Manufacturing and Controls)
information in a registration dossier.
Module 3 content

Module Content

3.1 Module 3 table of contents

3.2 Body of data

3.3 Literature references 54

 3.2 BODY OF
 DATA
3.2.S DRUG SUBSTANCE(S)
 3.2.S.1 General information (name, manufacturer)

 3.2.S.1.1 Nomenclature (name, manufacturer)

 3.2.S.1.2 Structure (name, manufacturer)

 3.2.S.1.3 General Properties (name, manufacturer)

 3.2.S.2 Manufacture of Drug Substance (name, manufacturer)

3.2.S.2.1 Manufacturer(s) (name, manufacturer)

 3.2.S.2.2 Description of Manufacturing Process and Process

Controls
(name, manufacturer)
 3.2.S.2.3 Control of Materials (name, manufacturer)

 3.2.S.2.4 Controls of Critical Steps and Intermediates

 3.2.S.2.5 Process Validation and/or Evaluation (name, manufacturer)

55
3.2.S.2.6 Manufacturing Process Development (name,

manufacturer)
 3.2.S.3 Characterization of Drug Substance
 3.2.S.4 Quality control of Drug Substance

 3.2.S.5 Reference Standards or Materials

6. Container Closure System

7. ity of Drug Substance
 3.2.P DRUG PRODUCT (NAME, DOSAGE FORM)

 3.2.P.1 Description and Composition of the Drug

Product
 3.2.P.2 Pharmaceutical Development

 3.2.P.3 Manufacture of Drug Product

 3.2.P.4 Control of Excipients

 3.2.P.5 Control of Drug Product

 3.2.P.6

3.2.P.7 Reference Standards or Materials
Container Closure 56
System
 3.2.P.8 Stability of drug product
 MODULE 4: NON-CLINICAL STUDY REPORTS

Module 4 describes the format and organisation of the

nonclinical (pharmaco-toxicological) data relevant to the
application.
 4.2 STUDY REPORTS
 4.2.1 Pharmacology
 4.2.2 Pharmacokinetics
 4.2.3 Toxicology
 4.3 literature references

57
 MODULE 5: CLINICAL STUDY REPORTS
Module 5 describes the format and organisation of the clinical
data relevant to the application.
o 5.3.1 Reports of Biopharmaceutical Studies
5.3.2 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

58
GUIDANCE FOR THE INDUSTRY

 Divided in 4 guidance
document
M4Q M4

CTD

59
 ECTD

6 months behind CTD

May, 2001, Tokyo, Step 2 of the eCTD ICH process was
agreed by Multidisciplinary Group 2 Expert Working
Group (ICH M2 EWG).
Specifications developed by ICH M2 EWG

Maintained by eCTD IWG

Electronic submission from applicant to regulator

60
M2 EWG – developed change control process to monitor
implementation process & provide solutions and added
flexibility found necessary during implementation

Addressed and resolved

-study report structure

-lifecycle management

-consistency with CTD

61
62
Paper CTD eCTD

63
File 1 File 2

File 3 File 4

/ 19
ECTD:ELECTRONIC CTD
- Developed by M2 EWG (Multidisciplinary 2
Expert Working Group) of ICH.

64
Industry <-----> Message <------> Agency

Paper submission has been

replaced by electronic
submission

/ 19
CHARACTERISTICS OF ECTD:-

1.Files Referenced in the XML Backbone(s)

(Extensible Markup Language)

65
REASONS:

1. It manages the large data for the entire submission

and for each document within the submission.

• This XML backbone allows the eCTD submission to

be viewed via a web browser and can be loaded on a
Web server.
/ 19
2.The file formats that can be
included in

66
Format
the eCTD (PDF) and XML.
are Portable Document

However other formats can be used for graphs

and
images.
JPEG PNG GIF
-may be used for higher resolution.

/ 19
3. All eCTD Submissions Include
Module 1

67
Module 1 Identifies following important
information:
Company Name
Drug Name
Submission Type
Submission Date
Application Number
Sequence Number

/ 19
 NOMENCLATURE FOR FILES AND ECTD
SUBMISSION.

EXAMPLE:- MODULE 2 FILE NOMENCLATURE AND eCTD

submission
68
Description File Name
• introduction 22-intro
• Quality overall summary 23-qos
• Non clinical Overview 24-nonclin-over
• Clinical Overview 25-clin-over
• Non clinical Written and 26-nonclin-sum Tabulated Summaries
• Clinical summary 27-clin-sum

/ 19
69
 ADVANTAGES OF CTD

 To make the reviewing of each application more easy and

also to avoid omission of critical data or analyses.
Omissions of such data can result in unnecessary delays in
approvals.
 To save time and resources

 To facilitate regulatory review and communications

 Appropriate format for the data

 Easy to understand and evaluation of data

 Applicable to all types of products (NCE,

radiopharmaceuticals, vaccines, herbals, etc.)

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 SILENT 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
71
 Facilitates electronic submissions
 LIMITATIONS………

 CTD is only a format, its not a single dossier with a single

content.
 Legal requirements differ in the different regions
 ICH guidelines have not yet harmonized in all
requirements
 Pharmacopoeias are not harmonized
 Applicant may have regional preferences.

72
•The eCTD has proved critical to improving application
submission efficiencies as well as reviewer efficiency.
•Besides delivering submission material to the reviewer in an
expedited manner, the eCTD format has made it easier to
develop standardized reviewer e-templates and review tools
for each of the review disciplines.

73
 IS CTD MANDATORY FOR ALL TYPE OF
SUBMISSIONS?
CTD is mandatory for all.
Import and/or manufacture and marketing approval of new

drugs (New chemical entity, new indication, new dosage

forms, new route of administration etc.), as a finished
pharmaceutical product, for first time submission and for
subsequent applications until 4 years.
Modified release formulations (even after 4 years of

approval by CDSCO)
Fixed Dose Combinations under item (a) of Appendix VI of

Schedule Y of Drugs and Cosmetics Rules 1945.

74
 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 the 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.
75
 REFERENCES
1. Molzon J; “The Common Technical Document: the changing face of New Drug
Application”; Nature Reviews – Drug Discovery; Volume 2, January 2003;Page 71-
74.
2. “Guidance for Industry on Preparation of Common Technical Document for
Import / Manufacture And Marketing Approval Of New Drugs For Human Use
(New Drug Application – NDA)”. Available at http://cdsco.nic.in/CTD_Guidance
%20-Final.pdf
3. Roth I R; “Preparing the Common Technical Document for Registration of
Pharmaceuticals for Human Use (CTD) – Insight and Recommendations”; Drug
Information Journal; Volume 42; 2008; Page149-159.
4. “The Common Technical Document- Quality (CTDQ)”. Available at
http://www.ema.europa.eu/ .
5. “Guideline M4: The Common Technical Document”. Available at
http://www.ich.org/products/ctd.html
6. Smith C G, O’donnell J T; “The Process of New Drug Discovery & Development”;
2nd Edition; Informa Health Care USA, Inc.; Page 477.
7. “ICH Harmonised Tripartite Guideline: Organisation Of The Common Technical
Document ForatThe Registration Of Pharmaceuticals For Human Use M4”. 76
 Available
http://www.ich.org/fileadmin
REFERENCES (CONTINUE):-
www.ich.org

www.cdsco.nic.in

77
http://www.fda.gov/cder/regulatory/ersr/
ectd.htm

http://esubmission.eudra.org/

http://www.mhlw.go.jp/english/index.html

http://www.tga.gov.au/docs/html/eugctd.htm

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