general dossier requirements for otc medicines · – required for otc dossiers since september...

General dossier requirements for OTC medicines

Kevin Eager OTC Medicines Evaluation, Market Authorisation Group, Office of Medicines Authorisation, TGA ARCS Scientific Congress 2014

11 September 2014

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Overview

• Requirements for an OTC dossier – general dossier requirements

– format of an electronic dossier

• Problems encountered with OTC dossiers


General dossier requirements

General dossier requirements for OTC medicines 2


• Language – English

• Common Technical Document format - CTD • Electronic

General requirements



• CTD format: – required for OTC dossiers since September 2013

• CTD format prescribes: – the organisation of the dossier across 5 modules – the order in which documents must appear so they are grouped logically and can be easily located

4 General dossier requirements for OTC medicines

CTD format


• Under the CTD format:

– each application is a collection of documents broken into one or more of 5 modules

– actual content of a dossier is dependent on the application level

– format of Modules 2, 3, 4, and 5 is described in the CTD guidelines

– format of Module 1 (for OTC applications) is to be described in an OTC CTD Module 1


CTD format

General dossier requirements CTD format

Module Descriptor Table of contents

1.0.1 Cover letter (letter of application) 1.0.3 Response to request for information

(including screening questions)

1.2.3 Patent certification

1.3.1 1.3.1.1 1.3.1.2 1.3.1.3

Product Information and package insert Product information – clean Product information – annotated Package insert

1.3.2 1.3.2.1 1.3.2.2

Consumer medicine information Consumer medicine information – clean Consumer medicine information - annotated

1.3.3 Label mock-ups and specimens

1.4 1.4.1 1.4.2 1.4.3

Information about the experts Quality Nonclinical Clinical

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• Modular structure aligned with Prescription Medicines eCTD structure

• Changes from current OTC module 1 structure – table of contents was 1.1 – no application form – was 1.2.1 – label mock-ups at 1.3.3 – was 1.3.4


General dossier requirements CTD format

Module Descriptor 1.5 Specific requirements for different types of

applications 1.5.1 Literature-based submission documents

1.5.5 Co-marketed medicine declarations (letters of authorisation)

1.5.7 OTC medicine assurances

1.5.8 Analytical validation summary

1.6 1.6.1 1.6.2 1.6.3 1.6.4

Master files and certificates of suitability Relevant external sources Applicant’s declaration Letters of access Certificates of suitability

1.9 1.9.1 1.9.2

Summary of biopharmaceutic studies Summary of bioavailability or bioequivalence study Justification for not providing biopharmaceutic studies

1.11 1.11.1 1.11.2 1.11.3 1.11.4

Foreign regulatory information Foreign regulatory status Foreign product information Data similarities and differences Foreign evaluation reports

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• Changes from current OTC module 1 structure – removal of quality related aspects of N1 & N2

applications now in Module 3 (if required)

– inclusion of OTC specific 1.5.7 - assurances 1.5.8 - validation summary

– removal of 1.7 - GMP


Format of an electronic dossier


Format of an electronic dossier Ideal format: • Electronic Common Technical Document – eCTD • Not a requirement Can also use: • Non-eCTD electronic Submission – NeeS • Not a requirement Minimum requirement • Compliance with TGA guideline – Guidelines on electronic OTC dossiers


Format of an electronic dossier Key aspects of compiling a workable dossier 1. Organising the dossier using folders 2. Having a comprehensive table of contents 3. Using meaningful file names 4. Text searchable 5. Appropriate use of bookmarks 6. Security 7. Uploading the dossier


Format of an electronic dossier 1. Organising the dossier using folders

Documents must be organised within folders that correspond to the CTD modules appropriate to the application.

Example 1 C2 application to change labelling


Format of an electronic dossier Example 2 N3 application


Format of an electronic dossier 2. Table of contents

– Located in the top level folder – Will have hyperlinks that navigate

to the individual documents in the dossier


Format of an electronic dossier 3. File names • Follow ICH conventions

– not prescriptive • Should be meaningful and indicative of the

position of the document within the CTD structure



4. Text searchable content – with limited exceptions, the documents should be text searchable – expect PDF documents to have been generated from electronic source documents

5. Bookmarks and hypertext links – appropriate use can greatly enhance navigation through a dossier


Key aspects of compiling a workable dossier ….. continued


6. Security on files – Dossier must not contain security settings

7. Uploading the dossier through eBS – preference is for the entire dossier to be ‘zipped’ – maximum individual file size for upload – 100MB


Key aspects of compiling a workable dossier ….. continued

Problems encountered with OTC dossiers



1. File naming - not meaningful 2. Not separating the dossier into the modular CTD structure 3. Lack of bookmarking


Main impediments to a workable dossier


N1 application • naming of files is not particularly helpful • some reference to CTD structure


File naming - not meaningful


N4 application – a single pdf – ~200 pages – comprised of Modules 1, 2, 3 & 5


Not separating the dossier into the modular CTD structure

Problems encountered with OTC dossiers On the positive side:

– the pdf was well bookmarked



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C1 application • a single document: >70 pages • not broken into the CTD modules

included M1 & M3 • not appropriately named • not text searchable • no bookmarking at all


Lack of bookmarking can hinder the evaluation process


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C1 application • a simple change application • broken into the CTD modules • clearly named • text searchable • no bookmarking – not required in this instance


Bookmarking: use where it helps with navigation

Summary


Summary 1. Provide dossiers in eCTD or NeeS format where possible

– not a requirement 2. Dossiers to comply with the Guidelines on electronic OTC dossiers 3. To have workable dossiers for all applications

– modular CTD structure – naming of documents – bookmarks – text searchable


Thank you
