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Paper format: Requirements for industry for providing regulatory informationUsing an eCTD format or a NeeS format electronic submission dossier as the source

Version 1.0, April 2011

Therapeutic Goods Administration

About the Therapeutic Goods Administration (TGA) The TGA is a division of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices. TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. The TGA investigates reports received by it to determine any necessary regulatory action. To report a problem with a medicine or medical device, please see the information on the TGA website.

Copyright© Commonwealth of Australia 2011This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights should be addressed to the Commonwealth Copyright Administration, Attorney General’s Department, National Circuit, Barton ACT 2600 or posted at http://www.ag.gov.au/ccaPaper dossier from electronic sourceV1.0, April 2011 Page i


Document change recordVersion Details of change Section Date1.0 First version All April 2011

Paper dossier from electronic sourceV1.0, April 2011 Page 1 of 23


Contents1. Purpose 3

2. Scope 3

3. Printing by sponsor 3

4. Number of copies required 3

5. Structure of paper submission dossier 3

6. Provision and labelling of tabs 4

7. Printed table of contents (ToC) 47.1 NeeS_________________________________________________________________________47.2 eCTD________________________________________________________________________4

8. Headers and footers 5

9. Reference to previous submissions & lifecycle attributes 5

10. Labelling volumes 5

Annex I—Example tables of contents 6I.1 Paper submission dossier from eCTD source_________________________6I.2 Paper submission dossier from NeeS source_________________________7



1. PurposeThe TGA requires all submission dossiers for an application for the registration or variation to an existing registration for a prescription medicine to be lodged in paper (hard copy) and electronic format. The paper submission dossier is the formal submission dossier. Both NeeS (non-eCTD electronic submission) and eCTD (electronic common technical document) formats are acceptable formats for the electronic copy of the submission dossier.1 This document provides instructions for creating a paper submission dossier where the source (original) information is in the NeeS or eCTD electronic format. This will allow sponsors to use the NeeS or eCTD format submission dosser as the antecedent submission, from which the formal paper submission dossier is then printed.2. ScopeThe scope of this document extends to all submission types where there is a TGA requirement for a paper submission dossier to be lodged. The relationship between a paper submission dossier and an electronic submission dossier is explained in Part A of transitional draft CTD Module 1—Administrative information and prescribing information for Australia (CTD Module 1).3. Printing by sponsorThe sponsor is responsible for lodging an effective paper submission dossier. The sponsor is solely responsible for the integrity and completeness of the material submitted. Information on what the TGA considers an ‘effective’ submission dosser is provided in Transitional mandatory requirements for an effective submission, Transitional prescription medicine streamlined submission process and Part A of transitional draft CTD Module 1.4. Number of copies requiredThe number of paper submission dossier copies required varies according to the type of submission. Information on the number of paper and electronic copies of the submission dossier required is provided in Part A of transitional draft CTD Module 1.5. Structure of paper submission dossier The eCTD structure, as defined in the ICH Electronic common technical document specification, is identical to the CTD structure required for paper submission dossiers. Guidance provided in the eCTD specification complements CTD format requirements. The NeeS specification, as detailed in Electronic format requirements for industry for providing regulatory information: Non-eCTD 1 As the TGA does not have the necessary software to fully manipulate eCTD format submission dossiers, the acceptance of an eCTD dossier is subject to the following conditions: eCTD dossiers will only be accepted for new chemical entity or new combination submissions eCTD dossiers must contain active links and comply with ICH specifications.


http://www.tga.gov.au/industry/pm-electronic-submission-dossiers.htm

http://estri.ich.org/eCTD/eCTD_Specification_v3_2_2.pdf

http://www.tga.gov.au/industry/pm-ctd.htm


http://www.tga.gov.au/industry/pm-ssp-transition.htm





http://www.ich.org/products/electronic-standards.html


electronic submissions (NeeS) for human medicinal products, is derived from the eCTD structure and similarly complements CTD format requirements. The structure of a paper submission dossier produced from a NeeS or eCTD format electronic submission dossier must be in accordance with the sequence of documents as referenced in either: the XML backbone of the eCTD the overall table of contents (ToC) of the NeeS. This sequence of documents must meet CTD regulatory requirements as detailed in Part A of transitional draft CTD Module 1. Where a document appears in several locations in the eCTD backbone or NeeS ToC, it must only appear once in the paper submission dossier, in the most appropriate and logical location. Further information on the paper size and printing requirements is detailed in Part A of transitional draft CTD Module 1.6. Provision and labelling of tabs The location of each document in the paper submission dossier must be marked by a tab identifier. The name for the tab identifier should be the name of the document, for example ’application form’, or the section heading according to the CTD format, for example 3.2.P.4.2 (see also Annex I.1). If the full name of the document is too long for the tab identifier, an alternative name that adequately identifies the document should be substituted. Tab identifiers (as described above) must be used in the table of contents as references to documents. Page numbers must not be used. For more information on tab identifiers and requirements for page numbering, see Part A of transitional draft CTD Module 1.7. Printed table of contents (ToC)7.1 NeeSThe NeeS ToCs are printed directly (either a single ctd-toc.pdf for the entire submission or the individual module ToCs—mx-toc.pdf). The comprehensive table of contents must include a complete list of all documents provided in the application by module. 7.2 eCTDFor eCTD, the index.xml and au-regional backbones, as viewed using style sheets and converted to PDF, must be printed and serve as the ToC in the paper submission dossier. For module 1, au-regional.xml must be printed via the style sheet to create the ToC. The comprehensive ToC for all modules based on index.xml must be placed before m2, m3, m4, and m5 of the paper submission dossier. The same ToCs are placed before each module—there is no need to create module-specific ToCs.





http://www.tga.gov.au/industry/pm-electronic-submission-dossiers.htm


8. Headers and footersThe header and footer information in the paper submission dossier must be identical to the information contained in the documents in the NeeS or eCTD format dossier. This must comply with the ICH Electronic common technical document specification, version 3.2.2, at Appendix 7, and the ICH Harmonised tripartite guideline. 9. Reference to previous submissions & lifecycle attributes In the eCTD, references to previous submissions or operation attributes in XML leaves can be used for automated lifecycle management of submissions. They are interpreted and processed by eCTD viewing tools to present a history of the information on a medicinal product. The paper submission dossier is identical in content to the eCTD sequence or NeeS format submission, and need not contain content that may be referred to from the submission but provided electronically in a previous submission. Where a document appears in several locations in the eCTD backbone or NeeS ToC, it must only appear once in the paper submission dossier, in the most appropriate and logical location.10. Labelling volumesMandatory requirements for the labelling of volumes in the paper submission dossier is provided in Part A of transitional draft CTD Module 1. Details of binder size and paper specifications are also provided in this document.



http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R3_Organisation/M4_R3__organisation.pdf

http://estri.ich.org/eCTD/eCTD_Specification_v3_2_2.pdf


Annex I—Example tables of contentsI.1 Paper submission dossier from eCTD sourceThis example ToC is based on index.xml viewed through Internet Explorer and converted to PDF. m2-common-technical-document-summaries

m2-2-introduction Introduction [new]

m2-3-quality-overall-summary m2-3-introduction

Introduction [new] m2-3-s-drug-substance [manufacturer: 123] [substance: xyz]

Drug Substance xyz [new] m2-3-p-drug-product [manufacturer: 123] [product name: abc] [dosage from: tablet]

Drug Product Table [new] m2-3-a-appendices

Appendices [new] m2-3-r-regional-information

Regional Information [new] m2-4-nonclinical-overview

Nonclinical Overview [new] m2-5-clinical-overview

Clinical Overview [new] Clinical Overview Appendix 1 [new] Clinical Overview Appendix 2 [new]

m2-6-nonclinical-written-and-tabulated-summaries m2-6-1-introduction

Introduction [new] m2-6-2-pharmacology-written-summary

Pharmacology Written Summary [new] m2-6-3-pharmacology-tabulated-summary

Pharmacology Tabulated Summary [new] m2-6-4-pharmacokinetics-written summary

Pharmacokinetics Written Summary [new] m2-6-5-pharmacokinetics-tabulated-summary

Pharmacokinetics Tabulated Summary [new] m2-6-6-toxicology-written-summary

Toxicology Written Summary [new] m2-6-7-toxicology-tabulated-summary

Toxicology Tabulated Summary [new] m2-7-clinical-summary

m2-7-1-summary-of-biopharmaceutic-studies-and-associated-analytical-methods Summary of Biopharmaceutic [new]

m2-7-2-summary-of-clinical-pharmacology-studies Summary Clinical Pharmacology [new]

m2-7-3-summary-of-clinical-efficacy [indication: pain] Summary of Clinical Efficacy Pain [new]

m2-7-4-summary-of-clinical-safety Summary of Clinical Safety [new]

m2-7-5-literature-references References [new]

m2-7-6-synopses-of-individual-studies Synopses of Individual Studies [new]



I.2 Paper submission dossier from NeeS sourceThis example ToC is based on printing the mx-toc.pdf files.Module 1 Administrative information and prescribing information

for AustraliaReference

1.0 Letter of application 1.01.0.0 Electronic lodgement cover sheet 1.0.01.0.1 Letter of application 1.0.11.0.2 Responses to questions 1.0.21.1 Comprehensive table of contents 1.11.2 Application forms 1.21.2.1 Application form 1.2.11.2.2 Pre-submission details 1.2.2 1.2.3 Patent certification 1.2.31.3 Medicine information documents, packaging, and labelling 1.31.3.1 Proposed Australian product information and package insert 1.3.11.3.2 Proposed Australian consumer medicine information 1.3.21.3.3 Therapeutic goods and use of human embryos or human embryonic stem cells or material derived from them 1.3.31.3.4 Label mock-ups and specimens 1.3.41.4 Information about the experts 1.41.4.1 Information about the expert—quality 1.4.11.4.2 Information about the expert—non-clinical 1.4.21.4.3 Information about the expert—clinical 1.4.31.5 Specific requirements for different types of applications 1.51.5.1 Literature based submission documents 1.5.11.5.2 Orphan drug designation 1.5.21.5.3 Genetically modified organisms: Consent from the Office of the Gene Technology Regulator 1.5.31.5.4 Additional trade name declarations 1.5.41.5.5 Co-marketed medicine declarations 1.5.51.6 Drug and plasma master files and Certificates of Suitability of Monographs of the European Pharmacopoeia 1.61.6.1 Relevant external sources 1.6.11.6.2 Sponsor’s declaration 1.6.21.6.3 Letters of access 1.6.3



1.6.4 Certificates of suitability (including annexes) 1.6.41.7 Good manufacturing practice 1.71.7.1 List of Australian manufacturer names and licence numbers 1.7.11.7.2 GMP clearance letters for all overseas manufacturing sites 1.7.21.7.3 Copies of applications for TGA GMP clearances 1.7.31.8 Compliance with meetings and pre-submission processes 1.81.8.1 Details of compliance with pre-submission meeting outcomes 1.8.11.8.2 Details of any additional data to be submitted 1.8.21.8.3 Declaration of compliance with pre-submission planning form and planning letter 1.8.31.9 Individual patient data 1.91.9.1 Individual patient data 1.9.11.10 Overseas regulatory status 1.101.10.1 Overseas regulatory status 1.10.11.10.2 Product information from Canada, the Netherlands, New Zealand, Sweden, UK, and USA 1.10.21.10.3 Data set similarities and differences 1.10.31.11 Summary of biopharmaceutic studies 1.111.11.1 Summary of a bioavailability or bioequivalence study 1.11.11.11.2 Justification for not providing appropriate biopharmaceutic studies 1.11.21.12 Paediatric development program 1.121.12.1 References to paediatric development program 1.12.11.13 Information relating to pharmacovigilance 1.131.13.1 Risk management plan for Australia 1.13.1Annex I Antibiotic resistance data Annex IAnnex II Overseas evaluation reports Annex IIModule 2 Common technical document summaries Reference2.2 Introduction 2.22.3.S Drug substance 2.3.S2.3.S.1 General information 2.3.S.12.3.S.2 Manufacture 2.3.S.22.3.S.3 Characterisation 2.3.S.32.3.S.4 Control of drug substance 2.3.S.42.3.S.5 Reference standards or materials 2.3.S.5



2.3.S.6 Container closure system 2.3.S.62.3.S.7 Stability 2.3.S.72.3.S Drug substance 2.3.S2.3.S.1 General information 2.3.S.12.3.S.2 Manufacture 2.3.S.22.3.S.3 Characterisation 2.3.S.32.3.S.4 Control of drug substance 2.3.S.42.3.S.5 Reference standards or materials 2.3.S.52.3.S.6 Container closure system 2.3.S.62.3.S.7 Stability 2.3.S.72.3.P Drug product 2.3.P2.3.P.1 Description and composition of the drug product 2.3.P.12.3.P.2 Pharmaceutical development 2.3.P.22.3.P.3 Manufacture 2.3.P.32.3.P.4 Control of excipients 2.3.P.42.3.P.5 Control of drug product 2.3.P.52.3.P.6 Reference standards or materials 2.3.P.62.3.P.7 Container closure system 2.3.P.72.3.P.8 Stability 2.3.P.82.3.A Appendices 2.3.A2.3.A.1 Facilities and equipment 2.3.A.12.3.A.2 Adventitious agents safety evaluation 2.3.A.22.3.A.3 Novel excipients 2.3.A.32.3.R Regional information 2.3.R2.4 Nonclinical overview 2.42.5 Clinical overview 2.52.6 Nonclinical written and tabulated summary 2.62.6.1 Introduction 2.6.12.6.2 Pharmacology written summary 2.6.22.6.3 Pharmacology tabulated summary 2.6.32.6.4 Pharmacokinetics written summary 2.6.42.6.5 Pharmacokinetics tabulated summary 2.6.52.6.6 Toxicology written summary 2.6.62.6.7 Toxicology tabulated summary 2.6.7Paper dossier from electronic sourceV1.0, April 2011 Page 9 of 23


2.7 Clinical summary 2.72.7.1 Summary of biopharmaceutic studies and associated analytical methods 2.7.12.7.2 Summary of clinical pharmacology studies 2.7.22.7.3 Summary of clinical efficacy 2.7.32.7.4 Summary of clinical safety 2.7.42.7.5 Literature references 2.7.52.7.6 Synopses of individual studies 2.7.6Module 3 Quality Reference3.2 Body of data 3.23.2.S Drug substance (substance—manufacturer) 3.2.S3.2.S.1 General information (substance—manufacturer) 3.2.S.13.2.S.1.1 Nomenclature (substance—manufacturer) 3.2.S.1.13.2.S.1.2 Structure (substance—manufacturer) 3.2.S.1.23.2.S.1.3 General properties (substance—manufacturer) 3.2.S.1.33.2.S.2 Manufacture (substance—manufacturer) 3.2.S.23.2.S.2.1 Manufacturer(s) (substance—manufacturer) 3.2.S.2.13.2.S.2.2 Description of manufacturing process and process controls (substance—manufacturer) 3.2.S.2.23.2.S.2.3 Control of materials (substance—manufacturer) 3.2.S.2.33.2.S.2.4 Control of critical steps and intermediates (substance—manufacturer) 3.2.S.2.43.2.S.2.5 Process validation and/or evaluation (substance—manufacturer) 3.2.S.2.53.2.S.2.6 Manufacturing process development (substance—manufacturer) 3.2.S.2.63.2.S.3 Characterisation (substance—manufacturer) 3.2.S.33.2.S.3.1 Elucidation of structure and other characteristics (substance—manufacturer) 3.2.S.3.13.2.S.3.2 Impurities (substance—manufacturer) 3.2.S.3.23.2.S.4 Control of drug substance (substance—manufacturer) 3.2.S.43.2.S.4.1 Specification (substance—manufacturer) 3.2.S.4.13.2.S.4.2 Analytical procedures (substance—manufacturer) 3.2.S.4.23.2.S.4.3 Validation of analytical procedures (substance—manufacturer) 3.2.S.4.3



3.2.S.4.4 Batch analyses (substance—manufacturer) 3.2.S.4.43.2.S.4.5 Justification of specification (substance—manufacturer) 3.2.S.4.53.2.S.5 Reference standards or materials (substance—manufacturer) 3.2.S.53.2.S.6 Container closure system (substance—manufacturer) 3.2.S.63.2.S.7 Stability (substance—manufacturer) 3.2.S.73.2.S.7.1 Stability summary and conclusions (substance—manufacturer) 3.2.S.7.13.2.S.7.2 Post-approval stability protocol and stability commitment (substance—manufacturer) 3.2.S.7.23.2.S.7.3 Stability data (substance—manufacturer) 3.2.S.7.33.2.S Drug substance (substance—manufacturer2) 3.2.S3.2.S.1 General information (substance—manufacturer2) 3.2.S.13.2.S.1.1 Nomenclature (substance—manufacturer2) 3.2.S.1.13.2.S.1.2 Structure (substance—manufacturer2) 3.2.S.1.23.2.S.1.3 General properties (substance—manufacturer2) 3.2.S.1.33.2.S.2 Manufacture (substance—manufacturer2) 3.2.S.23.2.S.2.1 Manufacturer(s) (substance—manufacturer2) 3.2.S.2.13.2.S.2.2 Description of manufacturing process and process controls (substance—manufacturer2) 3.2.S.2.23.2.S.2.3 Control of materials (substance—manufacturer2) 3.2.S.2.33.2.S.2.4 Control of critical steps and intermediates (substance—manufacturer2) 3.2.S.2.43.2.S.2.5 Process validation and/or evaluation (substance—manufacturer2) 3.2.S.2.53.2.S.2.6 Manufacturing process development (substance—manufacturer2) 3.2.S.2.63.2.S.3 Characterisation (substance—manufacturer2) 3.2.S.33.2.S.3.1 Elucidation of structure and other characteristics (substance—manufacturer2) 3.2.S.3.13.2.S.3.2 Impurities (substance—manufacturer2) 3.2.S.3.23.2.S.4 Control of drug substance (substance—manufacturer2) 3.2.S.43.2.S.4.1 Specification (substance—manufacturer2) 3.2.S.4.13.2.S.4.2 Analytical procedures (substance—manufacturer2) 3.2.S.4.23.2.S.4.3 Validation of analytical procedures (substance—manufacturer2) 3.2.S.4.33.2.S.4.4 Batch analyses (substance—manufacturer2) 3.2.S.4.43.2.S.4.5 Justification of specification (substance—manufacturer2) 3.2.S.4.53.2.S.5 Reference standards or materials 3.2.S.5



(substance—manufacturer2)3.2.S.6 Container closure system (substance—manufacturer2) 3.2.S.63.2.S.7 Stability (substance—manufacturer2) 3.2.S.73.2.S.7.1 Stability summary and conclusions (substance—manufacturer2) 3.2.S.7.13.2.S.7.2 Post-approval stability protocol and stability commitment (substance—manufacturer2) 3.2.S.7.23.2.S.7.3 Stability data (substance—manufacturer2) 3.2.S.7.33.2.P Drug product 3.2.P3.2.P.1 Description and composition of the drug product 3.2.P.13.2.P.2 Pharmaceutical development 3.2.P.23.2.P.2.1 Components of the drug product 3.2.P.2.13.2.P.2.2 Drug product 3.2.P.2.23.2.P.2.3 Manufacturing process development 3.2.P.2.33.2.P.2.4 Container closure system 3.2.P.2.43.2.P.2.5 Microbiological attributes 3.2.P.2.53.2.P.2.6 Compatibility 3.2.P.2.63.2.P.3 Manufacture 3.2.P.33.2.P.3.1 Manufacturer(s) 3.2.P.3.13.2.P.3.2 Batch formula 3.2.P.3.23.2.P.3.3 Description of manufacturing process and process controls 3.2.P.3.33.2.P.3.4 Controls of critical steps and intermediates 3.2.P.3.43.2.P.3.5 Process validation and/or evaluation 3.2.P.3.53.2.P.4 Control of excipient—compendial 3.2.P.43.2.P.4.1 Specifications 3.2.P.4.13.2.P.4.2 Analytical procedures n/a3.2.P.4.3 Validation of analytical procedures n/a3.2.P.4.4 Justification of specifications n/a3.2.P.4.5 Excipients of human or animal origin 3.2.P.4.53.2.P.4.6 Novel excipients 3.2.P.4.63.2.P.4 Control of excipient—non-compendial excipient 1 3.2.P.43.2.P.4.1 Specifications 3.2.P.4.13.2.P.4.2 Analytical procedures 3.2.P.4.23.2.P.4.3 Validation of analytical procedures 3.2.P.4.33.2.P.4.4 Justification of specifications 3.2.P.4.4



3.2.P.4.5 Excipients of human or animal origin 3.2.P.4.53.2.P.4.6 Novel excipients 3.2.P.4.63.2.P.5 Control of drug product 3.2.P.53.2.P.5.1 Specifications 3.2.P.5.13.2.P.5.2 Analytical procedures 3.2.P.5.23.2.P.5.3 Validation of analytical procedures 3.2.P.5.33.2.P.5.4 Batch analyses 3.2.P.5.43.2.P.5.5 Characterisation of impurities 3.2.P.5.53.2.P.5.6 Justification of specification(s) 3.2.P.5.63.2.P.6 Reference standards or materials 3.2.P.63.2.P.7 Container closure system 3.2.P.73.2.P.8 Stability 3.2.P.83.2.P.8.1 Stability summary and conclusions 3.2.P.8.13.2.P.8.2 Post-approval stability protocol and stability commitment 3.2.P.8.23.2.P.8.3 Stability data 3.2.P.8.33.2.R Regional information 3.2.R3.2.A Appendices 3.2.A3.2.A.1 Facilities and equipment—manufacturer 3.2.A.13.2.A.1 Facilities and equipment—manufacturer2 3.2.A.13.2.A.1 Facilities and equipment—manufacturer3 3.2.A.13.2.A.2 Adventitious agents safety evaluation—manufacturer 3.2.A.23.2.A.2 Adventitious agents safety evaluation—manufacturer2 3.2.A.23.2.A.3 Novel excipients 3.2.A.33.3 Literature references 3.33.3 Reference 1 3.33.3 Reference 2 3.33.3 Reference 3 3.3Module 4 Nonclinical study reports Reference4.2 Study reports 4.24.2.1 Pharmacology 4.2.14.2.1.1 Primary pharmacodynamics 4.2.1.1Study report 1 4.2.1.1Study report 2 4.2.1.1



Study report 3 4.2.1.14.2.1.2 Secondary pharmacodynamics 4.2.1.2Study report 1 4.2.1.2Study report 2 4.2.1.2Study report 3 4.2.1.24.2.1.3 Safety pharmacology 4.2.1.3Study report 1 4.2.1.3Study report 2 4.2.1.3Study report 3 4.2.1.34.2.1.4 Pharmacodynamic drug interaction 4.2.1.4Study report 1 4.2.1.4Study report 2 4.2.1.4Study report 3 4.2.1.44.2.2 Pharmacokinetics 4.2.24.2.2.1 Analytical methods and validation reports 4.2.2.1Study report 1 4.2.2.1Study report 2 4.2.2.1Study report 3 4.2.2.14.2.2.2 Absorption 4.2.2.2Study report 1 4.2.2.2Study report 2 4.2.2.2Study report 3 4.2.2.24.2.2.3 Distribution 4.2.2.3Study report 1 4.2.2.3Study report 2 4.2.2.3Study report 3 4.2.2.34.2.2.4 Metabolism 4.2.2.4Study report 1 4.2.2.4Study report 2 4.2.2.4Study report 3 4.2.2.44.2.2.5 Excretion 4.2.2.5Study report 1 4.2.2.5Study report 2 4.2.2.5Study report 3 4.2.2.54.2.2.6 Pharmacokinetic other pharmacokinetic studies drug 4.2.2.6Paper dossier from electronic sourceV1.0, April 2011 Page 14 of 23


interactions (nonclinical)Study report 1 4.2.2.6Study report 2 4.2.2.6Study report 3 4.2.2.64.2.2.7 Other pharmacokinetic studies 4.2.2.7Study report 1 4.2.2.7Study report 2 4.2.2.7Study report 3 4.2.2.74.2.3 Toxicology 4.2.34.2.3.1 Single-dose toxicity 4.2.3.1Study report 1 4.2.3.1Study report 2 4.2.3.1Study report 3 4.2.3.14.2.3.2 Repeat-dose toxicity 4.2.3.2Study report 1 4.2.3.2Study report 2 4.2.3.2Study report 3 4.2.3.24.2.3.3 Genotoxicity 4.2.3.34.2.3.3.1 In vitro 4.2.3.3.1Study report 1 4.2.3.3.14.2.3.3.2 In vivo 4.2.3.3.2Study report 1 4.2.3.3.2Study report 2 4.2.3.3.24.2.3.4 Carcinogenicity 4.2.3.44.2.3.4.1 Long-term studies 4.2.3.4.1Study report 1 4.2.3.4.14.2.3.4.2 Short– or medium–term studies 4.2.3.4.2Study report 1 4.2.3.4.2Study report 2 4.2.3.4.24.2.3.4.3 Other studies 4.2.3.4.3Study report 1 4.2.3.4.3Study report 2 4.2.3.4.3Study report 3 4.2.3.4.34.2.3.5 Reproductive and developmental toxicity 4.2.3.54.2.3.5.1 Fertility and early embryonic development 4.2.3.5.1Paper dossier from electronic sourceV1.0, April 2011 Page 15 of 23


Study report 1 4.2.3.5.14.2.3.5.2 Embryo–fetal development 4.2.3.5.2Study report 1 4.2.3.5.2Study report 2 4.2.3.5.24.2.3.5.3 Prenatal and postnatal development, including maternal function 4.2.3.5.3Study report 1 4.2.3.5.3Study report 2 4.2.3.5.3Study report 3 4.2.3.5.34.2.3.5.4 Studies in which the offspring (juvenile animals) are dosed and/or further evaluated 4.2.3.5.4Study report 1 4.2.3.5.44.2.3.6 Local tolerance 4.2.3.6Study report 1 4.2.3.64.2.3.7 Other toxicity studies 4.2.3.74.2.3.7.1 Antigenicity 4.2.3.7.1Study report 1 4.2.3.7.1Study report 2 4.2.3.7.14.2.3.7.2 Immunotoxicity 4.2.3.7.2Study report 1 4.2.3.7.24.2.3.7.3 Mechanistic studies 4.2.3.7.3Study report 1 4.2.3.7.34.2.3.7.4 Dependence 4.2.3.7.4Study report 1 4.2.3.7.4Study report 2 4.2.3.7.44.2.3.7.5 Metabolites 4.2.3.7.5Study report 1 4.2.3.7.5Study report 2 4.2.3.7.5Study report 3 4.2.3.7.54.2.3.7.6 Impurities 4.2.3.7.6Study report 1 4.2.3.7.64.2.3.7.7 Other 4.2.3.7.7Study report 1 4.2.3.7.74.3 Literature references 4.3



Reference 1 4.3Reference 2 4.3Reference 3 4.3Module 5 Clinical study reports Reference5.2 Tabular listing of all clinical studies 5.25.3 Clinical study reports 5.35.3.1 Reports of biopharmaceutic studies 5.3.15.3.1.1 Bioavailability (BA) study reports 5.3.1.1Study report 1 5.3.1.1Study report 2 5.3.1.1Study report 3 5.3.1.15.3.1.2 Comparative BA and bioequivalence (BE) study reports 5.3.1.2 Study report 1 5.3.1.2Study report 2 5.3.1.25.3.1.3 In vitro–in vivo correlation study reports 5.3.1.3Study 51002—title page 5.3.1.3Study 51002—synopsis 5.3.1.3Study 51002—body 5.3.1.3Study 51002—appendix–16–1–1 5.3.1.3Study 51002—appendix–16–1–2 5.3.1.3Study 51002—appendix–16–1–3 5.3.1.3Study 51002—appendix–16–1–4 5.3.1.3Study 51002—appendix–16–1–5 5.3.1.3Study 51002—appendix–16–1–6 5.3.1.3Study 51002—appendix–16–1–7 5.3.1.3Study 51002—appendix–16–1–8 5.3.1.3Study 51002—appendix–16–1–9 5.3.1.3Study 51002—appendix–16–1–10 5.3.1.3Study 51002—appendix–16–1–11 5.3.1.3Study 51002—appendix–16–1–12 5.3.1.3Study 51002—appendix–16–2–2 5.3.1.3Study 51002—appendix–16–2–7 5.3.1.3Study 51002—appendix–16–3–1 5.3.1.3



Study 51002—appendix–16–3–2 5.3.1.35.3.1.4 Reports of bioanalytical and analytical methods for human studies 5.3.1.4Study 51003—title–page.pdf 5.3.1.4Study 51003—synopsis.pdf 5.3.1.4Study 51003—body 5.3.1.4Study 51003—appendix–16–1–1.pdf 5.3.1.4Study 51003—appendix–16–1–2.pdf 5.3.1.4Study 51003—appendix–16–1–3.pdf 5.3.1.4Study 51003—appendix–16–1–4.pdf 5.3.1.4Study 51003—appendix–16–1–5.pdf 5.3.1.4Study 51003—appendix–16–1–7.pdf 5.3.1.4Study 51003—appendix–16–1–8.pdf 5.3.1.4Study 51003—appendix–16–1–9.pdf 5.3.1.4Study 51003—appendix–16–1–10.pdf 5.3.1.4Study 51003—appendix–16–1–11.pdf 5.3.1.4Study 51003—appendix–16–1–12.pdf 5.3.1.4Study 51003—appendix–16–2–2.pdf 5.3.1.4Study 51003—appendix–16–2–7.pdf 5.3.1.4Study 51003—appendix–16–3–1.pdf 5.3.1.4study 51003—appendix–16–3–2.pdf 5.3.1.45.3.2 Reports of studies pertinent to PK using human biomaterials 5.3.25.3.2.1 Plasma protein binding study reports 5.3.2.1Study report 1 5.3.2.15.3.2.2 Reports of hepatic metabolism and drug interaction studies 5.3.2.2Study report 1 5.3.2.25.3.2.3 Reports of studies using other human biomaterials 5.3.2.3study report 51006 5.3.2.35.3.3 Reports of Human PK studies 5.3.35.3.3.1 Healthy subject PK and initial tolerability study reports 5.3.3.1Study report 1 5.3.3.1Study report 2 5.3.3.15.3.3.2 Patient PK and initial tolerability study reports 5.3.3.2Study report 1 5.3.3.25.3.3.3 Intrinsic factor PK study reports 5.3.3.3



Study report 1 5.3.3.35.3.3.4 Extrinsic factor PK study reports 5.3.3.4Study report 1 5.3.3.45.3.3.5 Population PK study reports 5.3.3.5Study report 1 5.3.3.55.3.4 Reports of human PD studies 5.3.45.3.4.1 Healthy subject PD and PK/PD study reports 5.3.4.1Study report 1 5.3.4.15.3.4.2 Patient PD and PK/PD study reports 5.3.4.Study report 1 5.3.4.2Study report 2 5.3.4.25.3.5 Reports of efficacy and safety studies (confusion) 5.3.55.3.5.1 Study reports of controlled clinical studies pertinent to the claimed indication 5.3.5.1Study ab12345—synopsis 5.3.5.1Study ab12345—report body 5.3.5.1Study ab12345—protocol 5.3.5.1Study ab12345—protocol amendment a 5.3.5.1Study ab12345—randomisation code 5.3.5.1Study ab12345—adverse events listings 5.3.5.1Study ab12345—blank CRF 5.3.5.1Study ab12345—demographic table 5.3.5.1Study ab12345—ethics committee approval 5.3.5.1Study cd98765—synopsis 5.3.5.1Study cd98765—report body 5.3.5.1Study cd98765—protocol 5.3.5.1Study cd98765—randomisation code 5.3.5.1Study cd98765—adverse events listings 5.3.5.1Study cd98765—blank CRF 5.3.5.1Study cd98765—demographic table 5.3.5.1Study cd98765—ethics Committee Approval 5.3.5.15.3.5.2 Study reports of uncontrolled clinical studies 5.3.5.2Study report 51015 5.3.5.25.3.5.3 Reports of analyses of data from more than one study 5.3.5.3Study report 51016 5.3.5.3



5.3.5.4 Other clinical study reports 5.3.5.4Study report 51017 5.3.5.45.3.6 Post–marketing experience n/a5.3.7 Case report forms and individual patient listings when submitted 5.3.7Study ab12345—appendix 16–3–1 5.3.7Study ab12345—appendix 16–3–2 5.3.7Study ab12345—appendix 16–4 5.3.7Study cde98765—appendix 16–3–1 5.3.7Study cde98765—appendix 16–3–2 5.3.7Study cde98765—appendix 16–4 5.3.7Study 51002—appendix 16–3–1 5.3.7Study 51002—appendix 16–3–2 5.3.7Study 51002—appendix 16–4 5.3.7Study 51003—appendix 16–3–1 5.3.7Study 51003—appendix 16–3–2 5.3.7Study 510023—appendix 16–4 5.3.75.4 Literature references 5.4Reference 1 5.4Reference 2 5.4Reference 3 5.4


Therapeutic Goods AdministrationPO Box 100 Woden ACT 2606 AustraliaEmail: [email protected] Phone: 1800 020 653 Fax: 02 6232 8605www.tga.gov.au

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