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TRANSCRIPT
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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
2
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Key Milestones
The road to now
2004 Transitioned
to CTD
2011 Implemented
NeeS
2015 Implemented
eCTD
3
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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
4
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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 5
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Prescription medicine applications
0%
20%
40%
60%
80%
100%
0%
20%
40%
60%
80%
100%
New
Ent
ity /
Com
bina
tion
Gen
eric
EOI
Maj
or V
aria
tion
Chan
ge to
PI
invo
lvin
g da
ta
Min
or V
aria
tions
9D C
hang
es
Trad
e na
me
PSU
R / R
MP
Mas
ter F
iles
eCTD Uptake by Application Type % eCTD 2017 % eCTD 2018
*2018 data until 30 April 2018 6
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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
7
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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!
8
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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
9
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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
11
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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 12
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
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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 13
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
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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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XML Element
Description
Constraint
Occurrence
Defined List
reg-activity-lead
Regulatory Activity Lead
Mandatory
Single
Yes
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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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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 16
XML Element
Description
Constraint
Occurrence
Defined List
submission-mode
Submissions mode
Mandatory
Single
Yes
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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) 19
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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
20
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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 of 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 24
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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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https://www.tga.gov.au/electronic-submissions-and-data-review -
How to contact us Submission of dossier via
General dossier questions via [email protected]
Questions and feedback on specifications or electronic submission reform activities via [email protected]
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mailto:[email protected]:[email protected]:[email protected] - Electronic submissionsElectronic submissionsPresentation OverviewThe road to nowThe road to now - specifications and validation criteriaSome numbersSlide Number 7Why consider eCTD - BenefitsJanuary/July 2018 introducing version 3.1Requirements - eCTDRequirements - NeeSSlide Number 12Slide Number 13Slide Number 14Slide Number 15Slide Number 16Slide Number 17Changing Envelope DataWithdrawalsProvisional RegistrationsValidating sequencesImportance of validationSlide Number 23Slide Number 24The road to the FutureElectronic Submissions and Data Review Webpage How to contact usSlide Number 28