The CTD is a set of specifications for a dossier for the registration of medicines.

1. COMMON TECHNICAL DOCUMENT
(CTD)
1
Dr. Sukanta Sen
MBBS, DNB, MD, MNAMS
Dept. of Clinical & Exp. Pharmacology
CSTM, Kolkata

2. If you want to go fast go alone.
If you want to go far go together.
African Proverb
2

3. 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

4. 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

4

5. 
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

6. 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 regions
(U.S.A., Europe and Japan).
6

7. 7

8. Prior to the advent of the CTD, regulatory reviewers received
an application from one company and spent a year or more
engaged in its 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.
Regulators quickly saw the potential value of harmonizing
submission formats.
8

9. 9

10. ORIGIN OF CTD…
ICH
EWG
WAS OFFICIALLY SIGNED
OFF IN NOVEMBER 2000,
CTD
AT 10TH ANNIVERSERY of
ICH ;
SAN DIEGO,CALIFORNIA.
10

11. CTD
CTD IS A JOINT EFFORT OF 3 REGULATORY AGENCIES:
2. Food and Drug Administration (FDA, USA) and
3. 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).
11
1.European Medicines Agency (EMEA, Europe),

12. Any guideline which is given by ICH passes through different
steps.
 These different steps are called STATUS of that GUIDELINE.

STATUS
FUNCTIONALITY
Step 1
Development of Consensus
Step 2
12
Status of CTD
Text released for consultation
Step 3
Consultation outside ICH
Step 4
STEP 4 STATUS ACHIEVED IN
NOV.2000 IN 5TH ICH CONFERENCE
IN SANDIEGO..
STEP 5 STATUS ACHIEVED IN
MAY.2001 IN ICH MEETING IN
TOKYO.
ICH guideline finalized
Step 5
Implementation
GUIDANCE MADE AVAILABLE TO
INDUSTRY IN OCTOBER 16,2001 BY
FDA.

13. 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—
13
facilitating simultaneous submission, approval, and launch of new
drugs.

14. 
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.
14

15. 
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 beyond ICH regions.
15

16. 16

17. EVOLUTION OF THE COMMON
TECHNICAL DOCUMENT
17

18. 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.

19. 19

20. 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.
20

21. 21

22. 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

23. 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
23

24. 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.

25. PREPARING & ORGANIZATION
OF
CTD
It is organized into: Module
1: General Information
 Module 2: CTD summaries
 Module 3: Quality
 Module 4: Nonclinical study reports
 Module 5: Clinical study reports
25

26. 26

27. MODULE 1.
Administrative information and prescribing
information.
Document specific to each region.
E.g. Application form
Proposed label for use in the region
27

28. MODULE 1: GENERAL INFORMATION
1.1 Covering letter & comprehensive table of contents (modules 1
to 5)
1.2 Administrative information
1.2.1 Brief introduction about the applicant company
1.2.2 Duly filled and signed application in Form 44 and Treasury
Challan
1.2.3 Legal and Critical Documents
1.2.3.1 Copy of Clinical Trial/BE. No Objection letters issued by
CDSCO
1.2.3.2 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
28
Authority of the country of origin

29. 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
1.2.3.4 Undertaking or Declaration as per Annexure II
1.2.3.5 Certificate of Analysis
29

30. 1.2.4 Coordinates related to the application
1.2.4.1 Name, address, telephone, fax, e-mail of applicant of drug
product
1.2.4.2 Name, address, telephone, fax, e-mail of manufacturer of
drug substance
1.2.4.3 Name, address, telephone, fax, e-mail of the responsible
official
1.2.4.4 Name, address, telephone, fax, e-mail of other manufacturer(s)
involved in the production process
1.2.4.5 Name, designation, address, telephone, fax, e-mail of the
official responsible for releasing batches of drug product
1.2.4.6 Name, address, telephone, fax, e-mail of the authorized agent in India:
(for imported drug products)
1.2.4.7 Name, address, telephone, fax, e-mail of the manufacturing premises
holding Market Authorization of the drug product (for imported drug 30
products)

31. 1.3 GENERAL INFORMATION ON DRUG PRODUCT
1.3.1 A brief description of the drug and the therapeutic
class to which it belongs
1.3.2 Non-proprietary name or generic name of drug
1.3.3 Composition (As per label claim)
1.3.4 Dosage form
1.3.5 Strength per dosage unit
1.3.6 Dispensing requirements
1.3.7 Route of administration
1.3.8 Commercial presentation
1.3.9 Conditions of storage or conservation
1.3.10 Full Prescribing Information (Package insert)
1.3.11 Product Labeling: Proposed draft labels and cartons have to be
provided.
1.3.12 Summary of the packaging procedures for Indian shipments

31

32. 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
1.5.1 List of countries where proposed drug is Marketed
1.5.2 List of countries where proposed drug is Approved for
Marketing
1.5.3 List of countries where proposed drug is Approved as IND
1.5.4 List of countries where proposed drug is Withdrawn (if any,
with reasons for withdrawal)
1.5.5 Details of any restrictions on use, in any country where it is
marketed /approved

32

33. 
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
33

34. MODULE 2. CTD
SUMMARIES
2.1 Table of content of module 2
2.2 Introduction
2.3 Quality overall summaries
2.4 Non-clinical overview
2.5 Clinical overview
2.6 Non-clinical summaries
2.7 Clinical summaries
34

35. 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
Literature references
Synopses of individual studies
35

36. 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.
36

37. 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)
2.3.S.5 Reference Standards or Materials (name, manufacturer)
2.3.S.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

38. 2.3.P.2 Pharmaceutical Development (name, dosage form)
2.3.P.3 Manufacture (name, dosage form)
2.3.P.4 Control of Excipients (name, dosage form)
2.3.P.5 Control of Drug Product (name, dosage form)
2.3.P.6 Reference Standards or Materials (name, dosage
form)
2.3.P.7 Container Closure System (name, dosage form)
2.3.P.8 Stability (name, dosage form)
2.3.A appendices
38

39. 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

40. 2.4.1 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
2.4.2 Overview of the Non Clinical Testing Strategy
2.4.3 Pharmacology
2.4.4 Pharmacokinetics
2.4.5 Toxicology
2.4.6 Integrated Overview and Conclusions
2.4.7 List of Literature References
40

41. 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

42. 
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
42

43. 
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
43

44. 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

45. 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 pharmacodynamic effects
of a substance on physiological functions in relation 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
 2.6.4 Written Summary of Pharmacokinetics

45

46. 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

47. 2.6.6 Written Summary of Toxicology
 2.6.6.1 Brief Summary

Study type and
duration
Route of
Species
administration Compound
Compound
administered*
Single-dose toxicity
po and iv
Rat and mouse
Parent drug
Single-dose toxicity
po and iv
Rat and mouse
Metabolite X
1 month
po
Rat and dog
Parent drug
6 months
po
Rat
“
“
9 months etc.
po
Dog
“
“
Repeat-dose toxicity
47

48. 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
48
 2.6.6.6 Reproductive and Developmental Toxicity
 2.6.6.7 Local Tolerance


49. 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

50. 
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

51. 
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 Effects
51

52. 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
52
Related to Safety


53. 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
2.7.4.5.6 Drug Abuse
2.7.4.5.7 Withdrawal and Rebound
2.7.4.5.8 Effects on Ability to Drive or Operate Machinery or
Impairment of Mental Ability
o
o
o

2.7.4.6 Post-marketing Data

2.7.5 Literature References

2.7.6 Synopses of Individual Studies
53

54. 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

55. 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)


56. 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
3.2.S.6 Container Closure System
3.2.S.7 Stability 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 Reference Standards or Materials
 3.2.P.7 Container Closure System
 3.2.P.8 Stability of drug product

56

57. 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

58. MODULE 5: CLINICAL STUDY REPORTS
Module 5 describes the format and organisation of the clinical
data relevant to the application.
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
o
58

59. GUIDANCE FOR THE INDUSTRY

Divided in 4 guidance document
M4Q
M4
CTD
59

60. 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

61. 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. 62

63. Paper CTD
eCTD
63
File 1
File 2
File 3
File 4
/ 19

64. 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

65. CHARACTERISTICS OF ECTD:1. Files Referenced in the XML Backbone(s)
65
(Extensible Markup Language)
REASONS:
1.It manages the large data for the entire submission and for
each document within the submission.
2.This XML backbone allows the eCTD submission to be
viewed via a web browser and can be loaded on a Web
server.
/ 19

66. 66
2.The file formats that can be included in
the eCTD are Portable Document
Format (PDF) and XML.
However other formats can be used for graphs and
images.
JPEG
PNG
GIF
-may be used for higher resolution.
/ 19

67. 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

68. NOMENCLATURE FOR FILES AND ECTD
SUBMISSION.
EXAMPLE:- MODULE 2 FILE NOMENCLATURE AND eCTD
submission
Description
File Name
2.2 introduction
22-intro
2.3 Quality overall summary
23-qos
2.4 Non clinical Overview
24-nonclin-over
2.5 Clinical Overview
25-clin-over
2.6 Non clinical Written and
Tabulated Summaries
26-nonclin-sum
2.7 Clinical summary
27-clin-sum
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70. 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.)

70

71. 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

Facilitates electronic submissions
71

72. 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

73. •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

74. 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.
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75. 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

76. REFERENCES
1. Molzon J; “The Common Technical Document: the changing face of New Drug
Application”; Nature Reviews – Drug Discovery; Volume 2, January 2003;Page 7174.
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 For The Registration Of Pharmaceuticals For Human Use M4”.

Available at http://www.ich.org/fileadmin
76

77. REFERENCES (CONTINUE):www.ich.org
77
www.cdsco.nic.in
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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