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Modul 1: Administrative Documents

C001

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
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1.0 Cover Letter

C002

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
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1.2 Forms

C003

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1.2.2.26 GCP Inspections

C237

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 4

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

C027

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 5

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1.2.3 Annexes - Documents on Drug Product

Quality

C051

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 6

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1.2.3.1 DMF Letter of Access

C052

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1.2.3.2 Ph. Eur. Certificate of Suitability for Active

Substance

C053

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 8

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1.2.3.3 Ph. Eur. Certificate of Suitability for TSE

C054

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 9

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1.2.3.4 EMA Certificate for Plasma Master File (PMF)

C055

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 10

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1.2.3.5 EMA Certificate for Vaccine Antigen Master

File (VAMF)

C056

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 11

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1.2.4 Annexes – Manufacturing

C057

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 12

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1.2.4.1 GMP Certificate or Other GMP Documents

C058

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 13

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1.2.4.2 Documentation Concerning Manufacturing

Authorisation

C059

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1.2.4.3 Complete Manufacturing Information with

Flow Chart

C060

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 15

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1.2.4.4 Confirmation on GMP Conformity

C061

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 16

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1.2.5 Annexes – Others

C062

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 17

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1.2.5.1 Comparison of Approved Information for

Professionals with EU SmPC (for PSURs)

C063

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 18

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1.2.5.2 Company Core Data Sheet (for PSURs)

C064

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 19

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1.3 Product Information and Packaging Material

C029

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 20

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1.3.1 Information for Professionals

C030

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 21

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1.3.2 Information for Patients

C031

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 22

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1.3.3 Packaging Material

C032

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 23

Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
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1.3.4 Information for Professionals From Other

Countries

C033

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 24

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1.4 Information About the Expert

C034

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 25

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

C035

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 26

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1.4.2 Nonclinical

C036

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 27

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1.4.3 Clinical

C037

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 28

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1.5 Data of Bioavailability Studies

C038

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 29

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1.6 Environmental Risk Assessment

C039

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 30

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1.7 Decision of Foreign Authorities

C040

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 31

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1.7.1 Responses to LoQ

C041

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 32

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1.7.2 Assessment Report

C042

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 33

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1.7.3 EU Decision

C043

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 34

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1.7.4 FDA Decision

C044

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 35

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1.7.5 Decision of Other Foreign Authorities

C045

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 36

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1.7.6 Paragraph 13 Additional Documentation

C046

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 37

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1.7.6 Article 13 Additional Documentation

CC46

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1.8 Information Relating to Pharmacovigilance

C047

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 39

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1.8.1 Pharmacovigilance System

C048

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 40

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1.8.2 Risk Management System

C049

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 41

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1.9 Fast Track Status Decision

CA65

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 42

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1.10 Information Relating to Paediatrics

C050

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 43

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1.11 Orphan Drug Status Decision

CB65

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 44

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1.12 Art 14 Sec 1 Let abis-quater TPA

C238

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 45

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Additional Information

C065

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 46

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Responses to Swissmedic LoQ

C066

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 47

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Modul 2: Common Technical Document Summaries

C068

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 48

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2.1 Common Technical Document Table of Contents

(Modules 2-5)

C069

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 49

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2.2 CTD Introduction

C070

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2.3 Quality Overall Summary

C071

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 51

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2.3 Introduction

C072

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 52

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2.3.S Drug Substance

C073

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 53

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2.3.P Drug Product

C074

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 54

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2.3.A Appendices

C075

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 55

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2.3.R Regional Information

C076

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 56

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2.4 Nonclinical Overview

C077

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 57

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2.5 Clinical Overview

C078

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 58

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2.6 Nonclinical Written and Tabulated Summaries

C079

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 59

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2.6.1 Introduction

C080

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 60

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2.6.2 Pharmacology Tabulated Summaries

C081

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2.6.3 Pharmacology Written Summaries

C082

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2.6.4 Pharmacokinetics Tabulated Summaries

C083

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 63

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2.6.5 Pharmacokinetics Written Summaries

C084

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 64

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2.6.6 Toxicology Tabulated Summaries

C085

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2.6.7 Toxicology Written Summaries

C086

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2.7 Clinical Summary

C087

QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 67

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2.7.1 Biopharmaceutic Studies and Associated

Analytical Methods

C088

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2.7.2 Clinical Pharmacology Studies

C089

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2.7.3 Clinical Efficacy

C090

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2.7.4 Clinical Safety

C091

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2.7.5 Literature References

C092

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2.7.6 Synopses of Individual Studies

C093

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Modul 3: Quality

C094

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3.1 Table of Contents of Module 3

C095

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3.2 Body of Data

C096

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3.2.S Drug Substance

C097

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3.2.S.1 General Information

C098

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3.2.S.11 Nomenclature

C099

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3.2.S.12 Structure

C100

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3.2.S.13 General Properties

C101

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3.2.S.2 Manufacture

C102

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3.2.S.2.1 Manufacturer(s)

C103

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3.2.S.2.2 Description of Manufacturing Process and

Process Controls

C104

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3.2.S.2.3 Control of Materials

C105

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3.2.S.2.4 Controls of Critical Steps and

Intermediates

C106

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3.2.S.2.5 Process Validation and/or Evaluation

C107

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3.2.S.2.6 Manufacturing Process Development

C108

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3.2.S.3 Characterisation

C109

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3.2.S.3.1 Elucidation of Structure and Other

Characteristics

C110

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3.2.S.3.2 Impurities

C111

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3.2.S.4 Control of Drug Substance

C112

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3.2.S.4.1 Specification

C113

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3.2.S.4.2 Analytical Procedures

C114

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3.2.S.4.3 Validation of Analytical Procedures

C115

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3.2.S.4.4 Batch Analyses

C116

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3.2.S.4.5 Justification of Specification

C117

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3.2.S.5 Reference Standards or Materials

C118

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3.2.S.6 Container Closure System

C119

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3.2.S.7 Stability

C120

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3.2.S.7.1 Stability Summary and Conclusions

C121

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3.2.S.7.2 Post-approval Stability Protocol and

Stability Commitment

C122

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3.2.S.7.3 Stability Data

C123

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3.2.P Drug Product

C124

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3.2.P.1 Description and Composition of the Drug

Product

C125

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3.2.P.2 Pharmaceutical Development

C126

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3.2.P.2.1 Components

C127

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3.2.P.2.2 Product

C128

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3.2.P.2.3 Process

C129

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3.2.P.2.4 Container

C130

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3.2.P.2.5 Microbiology

C131

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3.2.P.2.6 Compatibility

C132

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3.2.P.3 Manufacture

C133

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3.2.P.3.1 Manufacturer(s)

C134

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3.2.P.3.2 Batch Formula

C135

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3.2.P.3.3 Description of Manufacturing Process and

Process Controls

C136

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3.2.P.3.4 Controls of Critical Steps and

Intermediates

C137

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3.2.P.3.5 Process Validation and/or Evaluation

C138

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3.2.P.4 Control of Exipients

C139

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3.2.P.4.1 Specifications

C140

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3.2.P.4.2 Analytical Procedures

C141

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3.2.P.4.3 Validation of Analytical Procedures

C142

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3.2.P.4.4 Justification of Specifications

C143

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3.2.P.4.5 Excipients of Human or Animal Origin

C144

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3.2.P.4.6 Novel Excipients

C145

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3.2.P.5 Control of the Drug Product

C146

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3.2.P.5.1 Specification(s)

C147

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3.2.P.5.2 Analytical Procedures

C148

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3.2.P.5.3 Validation of Analytical Procedures

C149

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3.2.P.5.4 Batch Analyses

C150

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3.2.P.5.5 Characterisation of Impurities

C151

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3.2.P.5.6 Justification of Specifications

C152

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3.2.P.6 Reference Standards or Materials

C153

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3.2.P.7 Container Closure Systems

C154

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3.2.P.8 Stability

C155

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3.2.P.8.1 Stability Summary and Conclusion

C156

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3.2.P.8.2 Post-approval Stability Protocol and

Stability Commitment

C157

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3.2.P.8.3 Stability Data

C158

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3.2.A Appendices

C159

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3.2.R Regional Information

C160

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3.3 Literature References

C161

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Modul 4: Nonclinical Study Reports

C162

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4.1 Table of Contents of Module 4

C163

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4.2 Study Reports

C164

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4.2.1 Pharmacology

C165

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4.2.1.1 Primary Pharmacodynamics

C166

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4.2.1.2 Secondary Pharmacodynamics

C167

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4.2.1.3 Safety Pharmacology

C168

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4.2.1.4 Pharmacodynamic Drug Interactions

C169

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4.2.2 Pharmacokinetics

C170

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4.2.2.1 Analytical Methods and Validation Reports

C171

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4.2.2.2 Absorption

C172

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4.2.2.3 Distribution

C173

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4.2.2.4 Metabolism

C174

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4.2.2.5 Excretion

C175

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4.2.2.6 Pharmacokinetic Drug Interactions

(Nonclinical)

C176

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4.2.2.7 Other Pharmacokinetic Studies

C177

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4.2.3 Toxicology

C178

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4.2.3.1 Single-Dose Toxicity

C179

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4.2.3.2 Repeat-Dose Toxicity

C180

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4.2.3.3 Genotoxicity

C181

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4.2.3.3.1 In Vitro

C182

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4.2.3.3.2 In Vivo

C183

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4.2.3.4 Carcinogenicity

C184

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4.2.3.4.1 Long-Term Studies

C185

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4.2.3.4.2 Short- or Medium-Term Studies

C186

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4.2.3.4.3 Other Studies

C187

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4.2.3.5 Reproductive and Developmental Toxicity

C188

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4.2.3.5.1 Fertility and Early Embryonic Development

C189

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4.2.3.5.2 Embryo-fetal Development

C190

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4.2.3.5.3 Prenatal and Postnatal Development,

Including Maternal Function

C191

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4.2.3.5.4 Studies in which the Offspring (Juvenile

Animals) Are Dosed and/or Further Evaluated

C192

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4.2.3.6 Local Tolerance

C193

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4.2.3.7 Other Toxicity Studies

C194

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4.2.3.7.1 Antigenicity

C195

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4.2.3.7.2 Immunotoxicity

C196

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4.2.3.7.3 Mechanistic studies

C197

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4.2.3.7.4 Dependence

C198

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4.2.3.7.5 Metabolites

C199

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4.2.3.7.6 Impurities

C200

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4.2.3.7.7 Other

C201

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4.3 Literature References

C202

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Modul 5: Clinical Study Reports

C203

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5.1 Table of Contents of Module 5

C204

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5.2 Tabular Listing of All Clinical Studies

C205

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5.3 Clinical Study Reports

C206

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5.3.1 Reports of Biopharmaceutic Studies

C207

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5.3.1.1 Bioavailability (BA) Study Reports

C208

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5.3.1.2 Comparative BA and Bioequivalence (BE)

C209

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5.3.1.3 In Vitro – In Vivo Correlation Study Reports

C210

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5.3.1.4 Reports of Bioanalytical and Analytical

Methods for Human Studies

C211

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5.3.2 Reports of Studies Pertinent to PK Using

Human Biomaterials

C212

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5.3.2.1 Plasma Protein Binding Study Reports

C213

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5.3.2.2 Reports of Hepatic Metabolism and Drug

C214

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5.3.2.3 Reports of Studies Using Other Human

Biomaterials

C215

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5.3.3 Reports of PK Studies

C216

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5.3.3.1 Healthy Subject PK and Initial Tolerability

C217

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5.3.3.2 Patient PK and Initial Tolerability Study

C218

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5.3.3.3 Intrinsic Factor PK Study Reports

C219

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5.3.3.4 Extrinsic Factor PK Study Reports

C220

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5.3.3.5 Population PK Study Reports

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5.3.4 Reports of PD Studies

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5.3.4.1 Healthy Subject PD and PK/PD Study

Reports

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5.3.4.2 Patient PD and PK/PD Study Reports

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5.3.5 Reports of Efficacy and Safety Studies

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5.3.5.1 Study Reports of Controlled Clinical Studies

Pertinent to the Claimed Indication

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5.3.5.2 Study Reports of Uncontrolled Clinical

Studies

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5.3.5.3 Reports of Analyses of Data from More Than

One Study

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5.3.5.4 Other Study Reports

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5.3.6 Reports of Postmarketing Experience

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5.3.7 Case Report Forms and Individual Patient

Listings

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5.4 Literature References

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