Presentation: Electronic submissions - New specifications ... · Electronic submissions New...

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

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

Key Milestones

The road to now

2004 Transitioned

to CTD

2011 Implemented

NeeS

2015 Implemented

eCTD

3

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

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

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

Why consider eCTD - Benefits

SPONSORS

Access to expedited pathways

Internationally standardised format

Lifecycle management

REGULATOR

Enhanced validation

Internationally standardised format

Lifecycle management

7

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

Requirements - eCTD eCTD Version 3.1 File downloads Checksums Australian eCTD regional specification and

validation criteria version 3.1 excel spreadsheets

9

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

Focus on the eCTD XML Envelope

11

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



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



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

14

XML Element

Description

Constraint

Occurrence

Defined List

reg-activity-lead

Regulatory Activity Lead

Mandatory

Single

Yes



sequence-description

Sequence Description Mandatory Single Yes

sequence-type Sequence Type Mandatory Multiple* Yes

email Contact Email Mandatory Multiple

15

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



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

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

17

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)

18

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

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

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

21

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

22

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

23

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

Electronic Submissions and Data Review Webpage

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

25
https://www.tga.gov.au/electronic-submissions-and-data-review

How to contact us Submission of dossier via

[email protected]

General dossier questions via [email protected]

Questions and feedback on specifications or electronic submission reform activities via [email protected]

26
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

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