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Electronic submissions New specifications experiences and challenges - - PowerPoint PPT Presentation

Oct 09, 2022 41 likes •325 views

Electronic submissions New specifications experiences and challenges Emma Richards Assistant Director Business Systems Review and Reporting Section Prescription Medicines Authorisation Branch, TGA ARCS Conference 2018 21 August 2018

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Electronic submissions

New specifications experiences and challenges

Emma Richards Assistant Director Business Systems Review and Reporting Section Prescription Medicines Authorisation Branch, TGA ARCS Conference 2018 21 August 2018

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Electronic submissions

New specifications experiences and challenges

Emma Richards Assistant Director Business Systems Review and Reporting Section Prescription Medicines Authorisation Branch, TGA ARCS Conference 2018 21 August 2018

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Presentation Overview

  • The road to now

– Key Milestones

  • Focus on the eCTD XML envelope

– Why it is important – What has changed as part of the specification update

  • Validation criteria

– Common errors and how to overcome these

  • The road to the future

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Key Milestones

The road to now

2004 Transitioned to CTD 2011 Implemented NeeS

2015 Implemented eCTD

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Implementation

The road to now - specifications and validation criteria

Late 2014

  • eCTD pilot
  • NeeS validation
  • Version 0.9

Regional Specifications & Validation criteria

April 2015

  • Version 3.0

Regional Specifications & Validation criteria

January 2018

  • NeeS envelope
  • Version 3.1

Regional Specifications & Validation criteria

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Current Status

Some numbers

  • Currently over 4000 dossiers

(e-IDs) within our system

  • In 2017 alone:

– ~1200 new dossiers – ~4000 submissions – ~7000 sequences

*2018 data until 30 April 2018

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Prescription medicine applications

0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100%

New Entity / Combination Generic EOI Major Variation Change to PI involving data Minor Variations 9D Changes Trade name PSUR / RMP Master Files

eCTD Uptake by Application Type

% eCTD 2017 % eCTD 2018

*2018 data until 30 April 2018

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Why consider eCTD - Benefits

SPONSORS

Access to expedited pathways Internationally standardised format Lifecycle management

REGULATOR

Enhanced validation Internationally standardised format Lifecycle management

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Updates

January/July 2018 – introducing version 3.1

Updated specifications and validation criteria

  • Last update 2015
  • MMDR
  • Greater knowledge / understanding
  • Automation
  • File downloads – react fast!

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Requirements - eCTD

  • eCTD Version 3.1 File downloads
  • Checksums
  • Australian eCTD regional specification and

validation criteria version 3.1 excel spreadsheets

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Requirements - NeeS

  • NeeS Version 2.0 File downloads

and checksum

  • NeeS envelope form
  • Relevant eCTD Version 3.1 file

downloads

  • Australian eCTD regional

specification and validation criteria version 3.1 excel spreadsheets

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Focus on the eCTD XML Envelope

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Version 3.1 XML Elements

XML Element Description Constraint Occurrence Defined List esub-id e-Identifier Mandatory Single client-id eBS Client ID Mandatory Single AAN Australian Approved Name(s) Mandatory Multiple

product-name

Trade Name(s) Mandatory Multiple artg-number ARTG Number(s) Optional Multiple

Key points:

  • The XML envelope is the key part of the eCTD specification
  • Provide a separate element for each entry when submitting

multiple values

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Version 3.1 XML Elements

XML Element Description Constraint Occurrence Defined List submission- number Submission or Application Number(s) Mandatory Multiple sequence- number Sequence Number Mandatory Single related- sequence- number Related Sequence Number Mandatory Single

Key points:

  • Include the full submission number/application number
  • Sequence numbers must be in chronological order

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Version 3.1 XML Elements

XML Element Description Constraint Occurrence Defined List reg-activity-lead Regulatory Activity Lead Mandatory Single Yes

Defined List

  • File downloads maintained by

the TGA

  • Contain a standard set of

codes for the corresponding envelope element

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Version 3.1 XML Elements

XML Element Description Constraint Occurrence Defined List sequence- description Sequence Description Mandatory Single Yes

sequence-type

Sequence Type Mandatory Multiple* Yes email Contact Email Mandatory Multiple

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Version 3.1 XML Elements

XML Element Description Constraint Occurrence Defined List

submission-

mode Submissions mode Mandatory Single Yes

Product A

Change 1 Change 2 Change 3

Work Grouping

Multiple changes for one product

Work Sharing

Change 1 Product A Product B Product C

One change for multiple products

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Changing Envelope Data

  • To remove a trade name / ARTG number:

– Sequence Type – Undefined Regulatory Activity (seq-type-52) – Sequence Description – Uncategorised {tradename removal} (seq-desc-24) – In the cover letter indicate which trade name/s and/or ARTG number/s are being maintained or removed

  • DO use the operation Delete to remove the ARTG number

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Withdrawals

  • Use the withdrawal function to….

‒ Withdraw an entire product lifecycle history (eID)

  • Sequence type – Product Withdrawal (seq-type-57)
  • Sequence description – Withdrawal (seq-desc-23)

‒ Withdraw a regulatory activity (submission)

  • Sequence type – Initial sequence type i.e. C – Extension of Indication
  • Sequence description – Withdrawal (seq-desc-23)
  • DO NOT use withdrawal to remove a trade name or ARTG number (to change envelope data)

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Provisional Registrations

  • Initial application

– Sequence type (type of application i.e. NCE) – Sequence description - Initial (seq-desc-2) – S31 responses as per normal process

  • Extension of provisional registration

– Sequence type - Extension of provisional registration (seq-type-61) – Sequence description - Initial (seq-desc-2)

  • Provision of additional clinical data

– Sequence type - Supplementary information (seq-type-45) – Sequence description - Provisional approval – rolling data submission – {date: d} (seq-desc-26)

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Validating sequences

  • Recommend validation prior to submitting to TGA
  • Validation errors result in delay
  • Good document management practices are important!!

– Currently too many instances of poor document management practices are being seen TIPS:  DO ensure that all documents within the sequence are closed prior to finalisation and validation  DO ensure that the dossier is structured with the e-ID as the root folder when compressed  DO NOT make changes to previous sequences

Publish Validate Review

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Importance of validation

  • TGA data demonstrates that the administrative burden of submission acceptance for eCTD is

greatly reduced when compared to NeeS

  • A well-structured eCTD dossier can streamline the administrative processing and evaluation

May 2018 Pass Fail Total eCTD 482 10 492 NeeS 284 107 391

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NeeS Validation Error

In general:

  • Wide range of validation errors occur for NeeS
  • Multiple reasons and fixes for these errors
  • Difficult to manually meet all validation requirements

Top cause of validation errors in NeeS is:

  • Hyperlink errors may be attributed to the link properties

in the PDF files. This can be resolved by changing the type

  • f action within the Link Properties menu.

Criterion 1.6 - Expected hyperlinks are present and functioning in Module TOC files

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eCTD Validation Errors

  • If there is content in M5.3.6 or M1.8 you MUST include ‘PV’
  • Example –

Criterion 4.2.10 – Envelope: submission-number

  • This is often caused by the inclusion of ‘thumbs.db’ files
  • Can be resolved by ‘un-hiding’ hidden/system files and locating and then deleting

Criterion 2.3 – Unreferenced files are not allowed

  • Make sure the pairing is appropriate by checking eCTD Sequence Matrix File Download

Criterion 4.2.9 - Envelope: Sequence type vs. Sequence Description

  • Be careful when making last minute changes

Criterion 4.1.8 – Modified file existence

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The road to the Future AU Regional specification update

Update guidance Dossier Portal New guidance Greater collaboration with software vendors SME assist Working groups Transition to eCTD Greater collaboration with industry eCTD version 4.0 Internal dossier management system updates Greater collaboration with CORs Further automation of the dossier receipt system

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Electronic Submissions and Data Review Webpage

New Electronic submission hub https://www.tga.gov.au/electronic-submissions-and-data-review.

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How to contact us

  • Submission of dossier via

eSubmissions@health.gov.au

  • General dossier questions via

eSubmissions@health.gov.au

  • Questions and feedback on specifications or

electronic submission reform activities via edr@health.gov.au

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