Modul 1: Administrative Documents · Modul 1: Administrative Documents C001. VO-Template Deckblätter / pages de garde / cover sheets CTD QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn

VO-Template Deckblätter / pages de garde / cover sheets

CTD

VM-ID: OS000_00_009dfe_VL - Vorlage / V1.0 / mra / ni / 01.01.2019 1

Swissmedic • Hallerstrasse 7 • 3012 Bern • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12

Modul 1: Administrative Documents

C001

.

.

.

.

.

.

.

.

.

.


CTD

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 2

Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12

1.0 Cover Letter

C002

.

.

.

.

.

.

.

.

.

.


CTD



1.2 Forms

C003

.

.

.

.

.

.

.

.

.

.


CTD



1.2.2.26 GCP Inspections

C237

.

.

.

.

.

.

.

.

.

.


CTD



1.2.2.99 Other Forms

C027

.

.

.

.

.

.

.

.

.

.


CTD



1.2.3 Annexes - Documents on Drug Product Quality

C051

.

.

.

.

.

.

.

.

.

.


CTD



1.2.3.1 DMF Letter of Access

C052

.

.

.

.

.

.

.

.

.

.


CTD



1.2.3.2 Ph. Eur. Certificate of Suitability for Active Substance

C053

.

.

.

.

.

.

.

.

.

.


CTD



1.2.3.3 Ph. Eur. Certificate of Suitability for TSE

C054

.

.

.

.

.

.

.

.

.

.


CTD



1.2.3.4 EMA Certificate for Plasma Master File (PMF)

C055

.

.

.

.

.

.

.

.

.

.


CTD



1.2.3.5 EMA Certificate for Vaccine Antigen Master File (VAMF)

C056

.

.

.

.

.

.

.

.

.

.


CTD



1.2.4 Annexes – Manufacturing

C057

.

.

.

.

.

.

.

.

.

.


CTD



1.2.4.1 GMP Certificate or Other GMP Documents

C058

.

.

.

.

.

.

.

.

.

.


CTD



1.2.4.2 Documentation Concerning Manufacturing Authorisation

C059

.

.

.

.

.

.

.

.

.

.


CTD



1.2.4.3 Complete Manufacturing Information with Flow Chart

C060

.

.

.

.

.

.

.

.

.

.


CTD



1.2.4.4 Confirmation on GMP Conformity

C061

.

.

.

.

.

.

.

.

.

.


CTD



1.2.5 Annexes – Others

C062

.

.

.

.

.

.

.

.

.

.


CTD



1.2.5.1 Comparison of Approved Information for Professionals with EU SmPC (for PSURs)

C063

.

.

.

.

.

.

.

.

.

.


CTD



1.2.5.2 Company Core Data Sheet (for PSURs)

C064

.

.

.

.

.

.

.

.

.

.


CTD



1.3 Product Information and Packaging Material

C029

.

.

.

.

.

.

.

.

.

.


CTD



1.3.1 Information for Professionals

C030

.

.

.

.

.

.

.

.

.

.


CTD



1.3.2 Information for Patients

C031

.

.

.

.

.

.

.

.

.

.


CTD



1.3.3 Packaging Material

C032

.

.

.

.

.

.

.

.

.

.


CTD



1.3.4 Information for Professionals From Other Countries

C033

.

.

.

.

.

.

.

.

.

.


CTD



1.4 Information About the Expert

C034

.

.

.

.

.

.

.

.

.

.


CTD



1.4.1 Quality

C035

.

.

.

.

.

.

.

.

.

.


CTD



1.4.2 Nonclinical

C036

.

.

.

.

.

.

.

.

.

.


CTD



1.4.3 Clinical

C037

.

.

.

.

.

.

.

.

.

.


CTD



1.5 Data of Bioavailability Studies

C038

.

.

.

.

.

.

.

.

.

.


CTD



1.6 Environmental Risk Assessment

C039

.

.

.

.

.

.

.

.

.

.


CTD



1.7 Decision of Foreign Authorities

C040

.

.

.

.

.

.

.

.

.

.


CTD



1.7.1 Responses to LoQ

C041

.

.

.

.

.

.

.

.

.

.


CTD



1.7.2 Assessment Report

C042

.

.

.

.

.

.

.

.

.

.


CTD



1.7.3 EU Decision

C043

.

.

.

.

.

.

.

.

.

.


CTD



1.7.4 FDA Decision

C044

.

.

.

.

.

.

.

.

.

.


CTD



1.7.5 Decision of Other Foreign Authorities

C045

.

.

.

.

.

.

.

.

.

.


CTD



1.7.6 Paragraph 13 Additional Documentation

C046

.

.

.

.

.

.

.

.

.

.


CTD



1.7.6 Article 13 Additional Documentation

CC46

.

.

.

.

.

.

.

.

.

.


CTD



1.8 Information Relating to Pharmacovigilance

C047

.

.

.

.

.

.

.

.

.

.


CTD



1.8.1 Pharmacovigilance System

C048

.

.

.

.

.

.

.

.

.

.


CTD



1.8.2 Risk Management System

C049

.

.

.

.

.

.

.

.

.

.


CTD



1.9 Fast Track Status Decision

CA65

.

.

.

.

.

.

.

.

.

.


CTD



1.10 Information Relating to Paediatrics

C050

.

.

.

.

.

.

.

.

.

.


CTD



1.11 Orphan Drug Status Decision

CB65

.

.

.

.

.

.

.

.

.

.


CTD



1.12 Art 14 Sec 1 Let abis-quater TPA

C238

.

.

.

.

.

.

.

.

.

.


CTD



Additional Information

C065

.

.

.

.

.

.

.

.

.

.


CTD



Responses to Swissmedic LoQ

C066

.

.

.

.

.

.

.

.

.

.


CTD



Modul 2: Common Technical Document Summaries

C068

.

.

.

.

.

.

.

.

.

.


CTD



2.1 Common Technical Document Table of Contents (Modules 2-5)

C069

.

.

.

.

.

.

.

.

.

.


CTD



2.2 CTD Introduction

C070

.

.

.

.

.

.

.

.

.

.


CTD



2.3 Quality Overall Summary

C071

.

.

.

.

.

.

.

.

.

.


CTD



2.3 Introduction

C072

.

.

.

.

.

.

.

.

.

.


CTD



2.3.S Drug Substance

C073

.

.

.

.

.

.

.

.

.

.


CTD



2.3.P Drug Product

C074

.

.

.

.

.

.

.

.

.

.


CTD



2.3.A Appendices

C075

.

.

.

.

.

.

.

.

.

.


CTD



2.3.R Regional Information

C076

.

.

.

.

.

.

.

.

.

.


CTD



2.4 Nonclinical Overview

C077

.

.

.

.

.

.

.

.

.

.


CTD



2.5 Clinical Overview

C078

.

.

.

.

.

.

.

.

.

.


CTD



2.6 Nonclinical Written and Tabulated Summaries

C079

.

.

.

.

.

.

.

.

.

.


CTD



2.6.1 Introduction

C080

.

.

.

.

.

.

.

.

.

.


CTD



2.6.2 Pharmacology Tabulated Summaries

C081

.

.

.

.

.

.

.

.

.

.


CTD



2.6.3 Pharmacology Written Summaries

C082

.

.

.

.

.

.

.

.

.

.


CTD



2.6.4 Pharmacokinetics Tabulated Summaries

C083

.

.

.

.

.

.

.

.

.

.


CTD



2.6.5 Pharmacokinetics Written Summaries

C084

.

.

.

.

.

.

.

.

.

.


CTD



2.6.6 Toxicology Tabulated Summaries

C085

.

.

.

.

.

.

.

.

.

.


CTD



2.6.7 Toxicology Written Summaries

C086

.

.

.

.

.

.

.

.

.

.


CTD



2.7 Clinical Summary

C087

.

.

.

.

.

.

.

.

.

.


CTD



2.7.1 Biopharmaceutic Studies and Associated Analytical Methods

C088

.

.

.

.

.

.

.

.

.

.


CTD



2.7.2 Clinical Pharmacology Studies

C089

.

.

.

.

.

.

.

.

.

.


CTD



2.7.3 Clinical Efficacy

C090

.

.

.

.

.

.

.

.

.

.


CTD



2.7.4 Clinical Safety

C091

.

.

.

.

.

.

.

.

.

.


CTD



2.7.5 Literature References

C092

.

.

.

.

.

.

.

.

.

.


CTD



2.7.6 Synopses of Individual Studies

C093

.

.

.

.

.

.

.

.

.

.


CTD



Modul 3: Quality

C094

.

.

.

.

.

.

.

.

.

.


CTD



3.1 Table of Contents of Module 3

C095

.

.

.

.

.

.

.

.

.

.


CTD



3.2 Body of Data

C096

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S Drug Substance

C097

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.1 General Information

C098

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.11 Nomenclature

C099

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.12 Structure

C100

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.13 General Properties

C101

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.2 Manufacture

C102

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.2.1 Manufacturer(s)

C103

.

.

.

.

.

.

.

.

.

.


CTD



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

C104

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.2.3 Control of Materials

C105

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.2.4 Controls of Critical Steps and Intermediates

C106

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.2.5 Process Validation and/or Evaluation

C107

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.2.6 Manufacturing Process Development

C108

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.3 Characterisation

C109

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.3.1 Elucidation of Structure and Other Characteristics

C110

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.3.2 Impurities

C111

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.4 Control of Drug Substance

C112

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.4.1 Specification

C113

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.4.2 Analytical Procedures

C114

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.4.3 Validation of Analytical Procedures

C115

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.4.4 Batch Analyses

C116

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.4.5 Justification of Specification

C117

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.5 Reference Standards or Materials

C118

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.6 Container Closure System

C119

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.7 Stability

C120

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.7.1 Stability Summary and Conclusions

C121

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment

C122

.

.

.

.

.

.

.

.

.

.


CTD



3.2.S.7.3 Stability Data

C123

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P Drug Product

C124

.

.

.

.

.

.

.

.

.

.


CTD



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

C125

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.2 Pharmaceutical Development

C126

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.2.1 Components

C127

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.2.2 Product

C128

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.2.3 Process

C129

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.2.4 Container

C130

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.2.5 Microbiology

C131

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.2.6 Compatibility

C132

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.3 Manufacture

C133

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.3.1 Manufacturer(s)

C134

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.3.2 Batch Formula

C135

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.3.3 Description of Manufacturing Process and Process Controls

C136

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.3.4 Controls of Critical Steps and Intermediates

C137

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.3.5 Process Validation and/or Evaluation

C138

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.4 Control of Exipients

C139

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.4.1 Specifications

C140

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.4.2 Analytical Procedures

C141

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.4.3 Validation of Analytical Procedures

C142

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.4.4 Justification of Specifications

C143

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.4.5 Excipients of Human or Animal Origin

C144

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.4.6 Novel Excipients

C145

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.5 Control of the Drug Product

C146

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.5.1 Specification(s)

C147

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.5.2 Analytical Procedures

C148

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.5.3 Validation of Analytical Procedures

C149

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.5.4 Batch Analyses

C150

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.5.5 Characterisation of Impurities

C151

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.5.6 Justification of Specifications

C152

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.6 Reference Standards or Materials

C153

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.7 Container Closure Systems

C154

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.8 Stability

C155

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.8.1 Stability Summary and Conclusion

C156

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment

C157

.

.

.

.

.

.

.

.

.

.


CTD



3.2.P.8.3 Stability Data

C158

.

.

.

.

.

.

.

.

.

.


CTD



3.2.A Appendices

C159

.

.

.

.

.

.

.

.

.

.


CTD



3.2.R Regional Information

C160

.

.

.

.

.

.

.

.

.

.


CTD



3.3 Literature References

C161

.

.

.

.

.

.

.

.

.

.


CTD



Modul 4: Nonclinical Study Reports

C162

.

.

.

.

.

.

.

.

.

.


CTD




C163

.

.

.

.

.

.

.

.

.

.


CTD



4.2 Study Reports

C164

.

.

.

.

.

.

.

.

.

.


CTD



4.2.1 Pharmacology

C165

.

.

.

.

.

.

.

.

.

.


CTD



4.2.1.1 Primary Pharmacodynamics

C166

.

.

.

.

.

.

.

.

.

.


CTD



4.2.1.2 Secondary Pharmacodynamics

C167

.

.

.

.

.

.

.

.

.

.


CTD



4.2.1.3 Safety Pharmacology

C168

.

.

.

.

.

.

.

.

.

.


CTD



4.2.1.4 Pharmacodynamic Drug Interactions

C169

.

.

.

.

.

.

.

.

.

.


CTD



4.2.2 Pharmacokinetics

C170

.

.

.

.

.

.

.

.

.

.


CTD



4.2.2.1 Analytical Methods and Validation Reports

C171

.

.

.

.

.

.

.

.

.

.


CTD



4.2.2.2 Absorption

C172

.

.

.

.

.

.

.

.

.

.


CTD



4.2.2.3 Distribution

C173

.

.

.

.

.

.

.

.

.

.


CTD



4.2.2.4 Metabolism

C174

.

.

.

.

.

.

.

.

.

.


CTD



4.2.2.5 Excretion

C175

.

.

.

.

.

.

.

.

.

.


CTD



4.2.2.6 Pharmacokinetic Drug Interactions (Nonclinical)

C176

.

.

.

.

.

.

.

.

.

.


CTD



4.2.2.7 Other Pharmacokinetic Studies

C177

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3 Toxicology

C178

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.1 Single-Dose Toxicity

C179

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.2 Repeat-Dose Toxicity

C180

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.3 Genotoxicity

C181

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.3.1 In Vitro

C182

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.3.2 In Vivo

C183

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.4 Carcinogenicity

C184

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.4.1 Long-Term Studies

C185

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.4.2 Short- or Medium-Term Studies

C186

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.4.3 Other Studies

C187

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.5 Reproductive and Developmental Toxicity

C188

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.5.1 Fertility and Early Embryonic Development

C189

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.5.2 Embryo-fetal Development

C190

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.5.3 Prenatal and Postnatal Development, Including Maternal Function

C191

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.5.4 Studies in which the Offspring (Juvenile Animals) Are Dosed and/or Further Evaluated

C192

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.6 Local Tolerance

C193

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.7 Other Toxicity Studies

C194

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.7.1 Antigenicity

C195

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.7.2 Immunotoxicity

C196

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.7.3 Mechanistic studies

C197

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.7.4 Dependence

C198

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.7.5 Metabolites

C199

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.7.6 Impurities

C200

.

.

.

.

.

.

.

.

.

.


CTD



4.2.3.7.7 Other

C201

.

.

.

.

.

.

.

.

.

.


CTD



4.3 Literature References

C202

.

.

.

.

.

.

.

.

.

.


CTD



Modul 5: Clinical Study Reports

C203

.

.

.

.

.

.

.

.

.

.


CTD




C204

.

.

.

.

.

.

.

.

.

.


CTD



5.2 Tabular Listing of All Clinical Studies

C205

.

.

.

.

.

.

.

.

.

.


CTD



5.3 Clinical Study Reports

C206

.

.

.

.

.

.

.

.

.

.


CTD



5.3.1 Reports of Biopharmaceutic Studies

C207

.

.

.

.

.

.

.

.

.

.


CTD



5.3.1.1 Bioavailability (BA) Study Reports

C208

.

.

.

.

.

.

.

.

.

.


CTD



5.3.1.2 Comparative BA and Bioequivalence (BE)

C209

.

.

.

.

.

.

.

.

.

.


CTD



5.3.1.3 In Vitro – In Vivo Correlation Study Reports

C210

.

.

.

.

.

.

.

.

.

.


CTD



5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human Studies

C211

.

.

.

.

.

.

.

.

.

.


CTD



5.3.2 Reports of Studies Pertinent to PK Using Human Biomaterials

C212

.

.

.

.

.

.

.

.

.

.


CTD



5.3.2.1 Plasma Protein Binding Study Reports

C213

.

.

.

.

.

.

.

.

.

.


CTD



5.3.2.2 Reports of Hepatic Metabolism and Drug

C214

.

.

.

.

.

.

.

.

.

.


CTD



5.3.2.3 Reports of Studies Using Other Human Biomaterials

C215

.

.

.

.

.

.

.

.

.

.


CTD



5.3.3 Reports of PK Studies

C216

.

.

.

.

.

.

.

.

.

.


CTD



5.3.3.1 Healthy Subject PK and Initial Tolerability

C217

.

.

.

.

.

.

.

.

.

.


CTD



5.3.3.2 Patient PK and Initial Tolerability Study

C218

.

.

.

.

.

.

.

.

.

.


CTD



5.3.3.3 Intrinsic Factor PK Study Reports

C219

.

.

.

.

.

.

.

.

.

.


CTD



5.3.3.4 Extrinsic Factor PK Study Reports

C220

.

.

.

.

.

.

.

.

.

.


CTD



5.3.3.5 Population PK Study Reports

C221

.

.

.

.

.

.

.

.

.

.


CTD



5.3.4 Reports of PD Studies

C222

.

.

.

.

.

.

.

.

.

.


CTD