checklist for registration of IND as per ICH CTD format

 INTRODUCTION: 

ABOUT ICH: “International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use”. This project brings together regulatory authorities of Europe, Japan & US, to discuss scientific & technical aspects of pharmaceutical product registration. ICH’s mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high quality medicines are developed, and registered and maintained in the most resource-efficient manner while meeting high standards.1 ICH aims to provide uniform standards for technical requirements for pharmaceuticals for human use. They are developed by regulatory and pharma industry authorities. The purpose of ICH guidelines is to ensure safe, effective, and high-quality medicines are developed and registered efficiently.

ABOUT CTD: CTD - Common Technical Document3 The agreement to assemble all the Quality, Safety, and Efficacy information in a common format called CTD has revolutionized the regulatory review processes, led to the harmonised electronic submission that, in turn, enabled the implementation of good review practices.3 The CTD is organized into five modules. Module 1 is region-specific and Modules 2, 3, 4, and 5 are intended to be common for all regions.

CHECKLIST: 

Module 1: Administrative information and prescribing information

Sr. no.	Name of documents	Checkbox
314.50(a)	Application
314.50(b)	Index
314.50(c)	Summary
314.50(d)	Technical section
314.50(e)	Sample and labeling
314.50(f)	Case report form and tabulation
314.50(g)	Other
314.50(h)	Patent information
314.50(i)	Patent certification
314.50(h)	Patent information
314.50(i)	Patent certification

Module 2: Common technical document summaries

Sr. no.	Name of documents	Checkbox
2.1	Common technical document table of contents(module 2-5)
2.2	CTD Introduction
2.3	Quality overall summary(QOS)
2.3.S.	Drug substance (name, manufacturer)
2.3.S.1	General information (name, manufacturer)
2.3.S.2	Manufacturer (name, manufacturer)
2.3.S.3	Characterization (name, manufacturer)
2.3.S.4	Control of drug substances (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	Drug product (name, dosage form)
2.3.P.1	Description and composition of drug product (name, dosage form)
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	Refence, standard 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
2.3.A.1	Facilities and equipment (name, manufacturer)
2.3.A.2	Adventitious agents safety evaluation (name, dosage form, manufacturer)
2.3.A.3	Excipients
2.3.R	REGIONAL INFORMATION
2.4	Non Clinical Overview
	General Aspects
	Contents and Structural Format
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	Literature References

2.7.2.5	Appendix
2.7.3	Summary of Clinical Efficacy
2.7.3.1	Background and Overview of ClinicalEfficacy
2.7.3.2	Summary of Results of IndividualStudies
2.7.3.3	Comparison and Analyses of ResultsAcross Studies
2.7.3.3.1	Study Populations
2.7.3.3.2	Comparison of Efficacy Results of allStudies
2.7.3.3.3	Comparison of Results in Sub-populations
2.7.3.4	Analysis of Clinical Information Relevent to Dosing Recommendations
2.7.3.5	Persistence of Efficacy and/orTolerance Effects
2.7.3.6	Appendix
2.7.4	Summary of Clinical Safety
2.7.4.1	Exposure to the Drug
2.7.4.1.1	Overall Safety Evaluation Plan andNarratives of Safety Studies
2.7.4.1.2	Overall Extent of Exposure
2.7.4.1.3	Demographic and other characteristicsif Study Population
2.7.4.2	Adverse Events
2.7.2.1	Background and Overview
2.7.2.2	Summary of Result of IndividualStudies
2.7.2.3	Comparison and Analyses of ResultsAcross Studies
2.7.2.4	Special Studies
2.7.4.2.1	Analysis of Adverse Events
2.7.4.2.2	Narratives

2.7.4.3	Clinical Laboratory Evaluations
2.7.4.4	Vital Sign , Physical Findings and Other Observations Related to Safety
2.7.4.5	Safety in Special Groups AndSituations
2.7.4.5.1	Intrinsic Factors
2.7.4.5.2	Extrinsic Factors
2.7.4.5.3	Drug Interactions
2.7.4.5.4	Use in Pregnancy and Lactation
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 OperateMachinery or Impairment of Mental Ability
2.7.4.6	Post-Marketing Data
2.7.4.7	Appendix
2.7.5	Literature References
2.7.6	Synopses of Individual Studies
2.7.4.2.1	Analysis of Adverse Events
2.7.4.2.2	Narratives
2.7.4.3	Clinical Laboratory Evaluations
2.7.4.4	Vital Sign , Physical Findings and Other Observations Related to Safety
2.7.4.5		Safety in Special Groups AndSituations
2.7.4.5.1		Intrinsic Factors
2.7.4.5.2		Extrinsic Factors

2.7.4.5.3	Drug Interactions
2.7.4.5.4	Use in Pregnancy and Lactation
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 OperateMachinery or Impairment of Mental Ability
2.7.4.6	Post-Marketing Data
2.7.4.7	Appendix
2.7.5	Literature References
2.7.6	Synopses of Individual Studies

MODULE 3: QUALITY

Sr. no.	Name of documents	Checkbox
3.1	Table of Contents of Module 3
3.2	Body Of Data
3.2.S	Drug Substance (name, manufacturer)
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	Manufacturer (name, manufacturer)
3.2.S.2.1	Manufacturer(s) (name, manufacturer)
3.2.S.2.2	Description of Manufacturing Processand Process controls (name, manufacturer)
3.2.S.2.3	Control Of Materials (name,manufacturer)
3.2.S.2.4	Control of Critical Steps and Intermediates (name, manufacturer)
3.2.S.2.5	Process validation and/or Evaluation(name, manufacturer)
3.2.S.2.6	Manufacturing Process Development(name, manufacturer)
3.2.S.3	Characterisation (name,manufacturer)
3.2.S.3.1	Elucidation of Structure and other Characteristics (name, manufacturer)
3.2.S.3.2	Impurities (name , manufacturer)
3.2.S.4	Control of Drug Substance(name ,manufacturer)
3.2.S.4.1	Specification (name , manufacturer)
3.2.S.4.2	Analytical Procedures (name ,manufacturer)

3.2.S.4.3	Validation of Analytical Procedures(name , manufacturer)
3.2.S.4.4	Batch Analyses (name , manufacturer)
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	Manufacturer (name, manufacturer)
3.2.S.2.1	Manufacturer(s) (name, manufacturer)
3.2.S.2.2	Description of Manufacturing Processand Process controls (name, manufacturer)
3.2.S.2.3	Control Of Materials (name,manufacturer)
3.2.S.2.4	Control of Critical Steps and Intermediates (name, manufacturer)
3.2.S.2.5	Process validation and/or Evaluation(name, manufacturer)
3.2.S.2.6	Manufacturing Process Development(name, manufacturer)
3.2.S.3	Characterisation (name,manufacturer)
3.2.S.3.1	Elucidation of Structure and other Characteristics (name, manufacturer)
3.2.S.3.2	Impurities (name , manufacturer)
3.2.S.4	Control of Drug Substance(name ,manufacturer)
3.2.S.4.1	Specification (name , manufacturer)
3.2.S.4.2	Analytical Procedures (name ,manufacturer)
3.2.S.4.3	Validation of Analytical Procedures(name , manufacturer)
3.2.S.4.4	Batch Analyses (name , manufacturer)
3.2.S.4.5	Justification of Specification (name ,manufacturer)
3.2.S.5	Reference Standards or Materials(name ,

	manufacturer)
3.2.S.6	Container Closure System (name,manufacturer)
3.2.S.7	Stability (name , manufacturer)
3.2.S.7.1	Stability Summary and Conclusions(name, manufacturer)
3.2.S.7.2	Post Approval Stability Protocol andStability Commitment (name, manufacturer)
3.2.S.7.3	Stability Date (name , manufacturer)
3.2.P	Drug Product (name, dosage form)
3.2.P.1	Description and Composition of DrugProduct (name, dosage form)
3.2.P.2	Pharmaceutical Develpoment (name,dosage form)
3.2.P.2.1	Components of the Drug Product(name, dosage form)
3.2.P.2.1. 1	Drug Substance (name , dosage form)
3.2.P.2.1. 2	Excipient (name, dosage form)
3.2.P.2.2	Drug Product (name, dosage form)
3.2.P.2.2. 1	Formulation Development (name,dosage form)
3.2.P.2.2. 2	Overages (name, dosage form)
3.2.P.2.2. 3	Physicochemical and BiologicalProperties (name, dosage form)
3.2.P.2.3	Manufacturing Process Development(name, dosage form)
3.2.P.2.4	Container Closure System (name,dosage form)
3.2.P.2.5	Microbiological Attributes (name,dosage form)
3.2.P.2.6	Compatibility (name , dosage form)
3.2.P.3	Manufacturer (name, dosage form)
3.2.P.3.1	Manufacturer(s) (name, dosage form)

3.2.P.3.2	Batch Formula (name, dosage form)
3.2.P.3.3	Description of Manufacturing Processand Process Controls (name, dosage form)
3.2.P.3.4	Control of Critical Steps and Intermediates (name, dosage form)
3.2.P.3.5	Process Validation and/or Evaluation(name, dosage form)
3.2.P.4	Control Of Excipients (name, dosageform)
3.2.P.4.1	Specification (name, dosage form)
3.2.P.4.2	Analytical Procedure (name, dosageform)
3.2.P.4.3	Validation of Analytical Procedures(name, dosage form)
3.2.P.4.4	Justification of Specifications (name,dosage form)
3.2.P.4.5	Excipients of Human or Animalorigin (name, dosage form)
3.2.P.4.6	Novel Excipients (name, dosageform)
3.2.P.5	Control Of Drug Product (name,dosage form)
3.2.P.5.1	Specification (name ,dosage form)
3.2.P.5.2	Analytical Procedure (name, dosageform)
3.2.P.2.4	Container Closure System (name,dosage form)
3.2.P.2.5	Microbiological Attributes (name,dosage form)
3.2.P.2.6	Compatibility (name , dosage form)
3.2.P.3	Manufacturer (name, dosage form)
3.2.P.3.1	Manufacturer(s) (name, dosage form)
3.2.P.3.2	Batch Formula (name, dosage form)
3.2.P.3.3	Description of Manufacturing Processand Process Controls (name, dosage form)
3.2.P.3.4	Control of Critical Steps and Intermediates (name, dosage form)
3.2.P.3.5	Process Validation and/or Evaluation(name, dosage form)
3.2.P.4	Control Of Excipients (name, dosageform)
3.2.P.4.1	Specification (name, dosage form)
3.2.P.4.2	Analytical Procedure (name, dosageform)
3.2.P.4.3	Validation of Analytical Procedures(name, dosage form)
3.2.P.4.4	Justification of Specifications (name,dosage form)
3.2.P.4.5	Excipients of Human or Animalorigin (name,

	dosage form)
3.2.P.4.6	Novel Excipients (name, dosageform)
3.2.P.5	Control Of Drug Product (name,dosage form)
3.2.P.5.1	Specification (name ,dosage form)
3.2.P.5.2	Analytical Procedure (name, dosageform)
3.2.P.5.3	Validation of Analytical Procedures(name, dosage form)
3.2.P.5.4	Batch Analysis (name, dosage form)
3.2.P.5.5	Characterisation of impurities (name,dosage form)
3.2.P.5.6	Justification of Specification(name,dosage form)
3.2.P.6	Reference Standard or Materials(name, dosage form)
3.2.P.7	Container Closure System(name,dosage form)
3.2.P.8	Stability(name, dosage form)
3.2.P.8.1	Stability Summary and Conclusion(name, dosage form)
3.2.P.8.2	Post-approval        Stability      Protocol                              and Stability Commitment(name, dosageform)
3.2.P.8.3	Stability Data(name, dosage form)
3.2.A	APPENDICES
3.2.A.1	Facilities and Equipment (name,dosage form)
3.2.A.2	Adventitious Agents Safety Evaluation (name, dosage form)
3.2.A.3	Excipients(name, dosage form)
3.2.R	Regional Information
3.3	Litterature References

 

MODULE 4: NON CLINICAL STUDY REPORTS

SR.NO.	NAME OF DOCUMENT	Checkbox
4.1	Table of contents of Module 4
4.2	Study Reports
4.3	Literature References

 

MODULE 5: CLINICAL STUDY REPORTS

SR.NO.	NAME OF DOCUMENT	Checkbox
5.1	Table Of Contents Of Module 5
5.2	Tabular Listing Of All Clinical  Studies
5.3	Clinical Study Reports
5.3.1	Reports of Biopharmaceutical Studies
5.3.1.1	Bioavailability(BA) Study Reports
5.3.1.2	Comparative BA And Bioequivalence(BE) Study Reports
5.3.1.3	In Vivo – In Vitro Correlation Study Reports
5.3.1.4	Reports Of Bioanalytical and Analytical Methods for Human Studies
5.3.2	Reports of Studies Pertinent to Pharmacokinetics Using Human Biomaterials