Comprehensive Table of Contents

Module 1: Administrative Information and prescribing information

Sr. No.
1.0
1.1
1.2
1.3
1.3.1
1.3.2
1.3.3
1.3.4
1.3.5
1.3.6
1.4
1.4.1
1.4.2
1.4.3
1.5
1.5.1
1.5.2
1.5.3
1.5.4
1.5.5
1.6
1.6.1
1.6.2
1.7
1.7.1
1.7.2
1.8
1.9

Contents
Cover Letter
Comprehensive Table of Contents
Application Form
Product Information
SPC, Labeling and Package Leaflet
Mock-up
Specimen
Consultation with Target Patient Group
Product Information already approved in the Member States
Braille
Information about the Experts
Quality
Non-Clinical
Clinical
Specific Requirements for Different Types of Applications
Information for Bibliographical Applications
Information for Generic, Hybrid or Bio-similar Applications
(Extended) Data/Market Exclusivity
Exceptional Circumstances
Conditional Marketing Authorization
Environmental Risk Assessment
Non-GMO
GMO
NTA, Vol. 2B-CTD, Module 1 edition April 2006 3
Information relating to Orphan Market Exclusivity
Similarity
Market Exclusivity
Information relating to Pharmacovigilance
Information relating to Clinical Trials
Responses to Questions
Additional Data

Page No.

Module 2: Common Technical Document Summaries

Sr. No.
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
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
2.4
2.5
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

Contents
Table of Contents
Introduction
Quality Overall Summary
Drug Substance
General Information
Manufacture
Characterization
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
Nonclinical Overview
Clinical Overview
Nonclinical Summary
Introduction
Pharmacology Written Summary
Pharmacology Tabulated Summary
Pharmacokinetics Written Summary
Pharmacokinetics Tabulated Summary
Toxicology Written Summary
Toxicology Tabulated Summary
Clinical Summaries
Summary of Biopharmaceutic and Associated
Analytical Methods
Summary of Clinical Pharmacology Studies
Summary of Clinical Efficacy
Summary of Safety
References
Synopses of Individual Studies

Page No.

Module 3: Quality
NO.
3.1
3.2
3.2.S
3.2.S.1
3.2.S.1.1
3.2.S.1.2
3.2.S.1.3
3.2.S.2
3.2.S.2.1
3.2.S.2.2
3.2.S.2.3
3.2.S.2.4
3.2.S.2.5
3.2.S.2.6
3.2.S.3
3.2.S.3.1
3.2.S.3.2
3.2.S.4
3.2.S.4.1
3.2.S.4.2
3.2.S.4.3
3.2.S.4.4
3.2.S.4.5
3.2.S.5
3.2.S.6
3.2.S.7
3.2.S.7.1
3.2.S.7.2
3.2.S.7.3
3.2.P
3.2.P.1
3.2.P.2
3.2.P.2.1
3.2.P.2.1.1
3.2.P.2.1.2
3.2.P.2.2
3.2.P.2.2.1
3.2.P.2.2.2
3.2.P.2.2.3
3.2.P.2.3

PARAMETERS
MODULE 3 TABLE OF CONTENT
BODY OF DATA
Drug Substance
General Information
Nomenclature
Structure
General Properties
Manufacture
Manufacturer(s)
Description of Manufacturing Process and Process
Controls
Control of Raw Materials
Controls of Critical Steps and Intermediates
Process Validation and/or Evaluation
Manufacturing Process Development
Characterization
Elucidation of Structure and other Characteristics
Impurities
Control of Drug Substance
Specification
Analytical Procedures
Validation of Analytical Procedures
Batch Analyses
Justification of Specification
Reference Standards or Materials
Container Closure System
Stability
Stability Summary and Conclusions
Post-approval Stability Protocol and Stability
Commitment
Stability Data
Drug Product
Description and Composition of the Drug Product
Pharmaceutical Development
Components of the Drug Product
Drug Substance
Excipients
Drug Product
Formulation Development
Overages
Physicochemical and Biological Properties
Manufacturing Process Development

PAGE NO.

3.2.P.2.4
3.2.P.2.5
3.2.P.2.6
3.2.P.3
3.2.P.3.1
3.2.P.3.2
3.2.P.3.3
3.2.P.3.4
3.2.P.3.5
3.2.P.4
3.2.P.4.1
3.2.P.4.2
3.2.P.4.3
3.2.P.4.4
3.2.P.4.5
3.2.P.4.6
3.2.P.5
3.2.P.5.1
3.2.P.5.2
3.2.P.5.3
3.2.P.5.4
3.2.P.5.5
3.2.P.5.6
3.2.P.6
3.2.P.7
3.2.P.8
3.2.P.8.1
3.2.P.8.2
3.2.P.8.3
3.3

Container Closure System

Microbiological Attributes
Compatibility
Manufacture
Manufacturer(s)
Batch Formula
Description of Manufacturing Process and Process
Controls
Controls of Critical Steps and Intermediates
Process Validation and/or Evaluation
Control of Excipients
Specifications
Analytical Procedures
Validation of Analytical Procedures
Justification of Specifications
Excipients of Human or Animal Origin
Novel Excipients
Control of Drug Product
Specification(s)
Analytical Procedures
Validation of Analytical Procedures
Batch Analyses
Characterization of Impurities
Justification of Specification(s)
Reference Standards or Materials
Container Closure System
Stability
Stability Summary and Conclusions
Post-approval Stability Protocol and Stability
Commitment
Stability Data
LITERATURE REFERENCES

Module 4: Non-clinical Study Reports

Sr. No.
4.1
4.2
4.2.1
4.2.1.1
4.2.1.2
4.2.1.3
4.2.1.4
4.2.2
4.2.2.1
4.2.2.2
4.2.2.3
4.2.2.4
4.2.2.5
4.2.2.6
4.2.2.7
4.2.3
4.2.3.1
4.2.3.2
4.2.3.3
4.2.3.3.1
4.2.3.3.2
4.2.3.4
4.2.3.4.1
4.2.3.4.2
4.2.3.4.3
4.2.3.5
4.2.3.5.1
4.2.3.5.2
4.2.3.5.3

Contents
Table of contents
Study Reports
Pharmacology
Primary Pharmacodynamics
Secondary Pharmacodynamics
Safety Pharmacology
Pharmacodynamics Drug Interactions
Pharmacokinetics
Analytical Methods and Validation Reports
Absorption
Distribution
Metabolism
Excretion
Pharmacokinetic Drug Interactions
Other Pharmacokinetic studies
Toxicology
Single-Dose Toxicity
Repeat-Dose Toxicity
Genotoxicity
In vitro
In vivo
Carcinogenicity
Long term studies
Short term or medium term studies
Other studies
Reproductive and Developmental Toxicity
Fertility and early embryonic development
Embryo-fetal development
Prenatal and postnatal development, including maternal
function
4.2.3.5.4 Studies in which the offspring are dosed and /or further
evaluated
4.2.3.6
Local Tolerance
4.2.3.7
Other Toxicity studies (If available)
4.3
Literature References

Page No.

Module 5: Clinical Study Reports

Sr. No.
5.1
5.2
5.3
5.3.1
5.3.1.1
5.3.1.2
5.3.1.3
5.3.1.4
5.3.2
5.3.2.1
5.3.2.2
5.3.2.3
5.3.3
5.3.3.1
5.3.3.2
5.3.3.3
5.3.3.4
5.3.3.5
5.3.4
5.3.4.1
5.3.4.2
5.3.5
5.3.5.1
5.3.5.2
5.3.5.3
5.3.5.4
5.3.5.5
5.4

Contents
Table of contents
Tabular listing of all clinical studies
Clinical Study Reports
Reports of Biopharmaceutics Studies
Bioavailability Study Reports
Comparative BA and Bioequivalence (BE) study Reports
In vitro-In vivo Correlation Study Reports
Reports of Bioanalytical and Analytical Methods for
Human Studies
Reports of studies Pertinent to Pharmacokinetics using
Human Biomaterials
Plasma Protein Binding Study Reports
Reports of Hepatic Metabolism and Drug Interaction
Studies
Reports of Studies Using Other Human Biomaterials
Reports of Human Pharmacokinetic (PK) Studies
Healthy Subject PK and Initial Tolerability Study
Reports
Patient PK and Initial Tolerability Study Reports
Intrinsic Factor PK Study Reports
Extrinsic Factor PK Study Reports
Population PK Study Reports
Reports on Human Pharmacodynamic (PD) Studies
Healthy Subject PD and PK/PD Study Reports
Patient PD and PK/PD Study Reports
Reports on Efficacy and Safety Studies
Study Report of Uncontrolled Clinical Studies
Reports of Analysis of Data from More than One Study
Other Clinical Study Reports
Report on Post-Marketing Experience
Case Report Forms and Individual Patient Listings
Literature References

Page No.