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Prescription medicine BPR update newsletter, May 2011

1 June 2011


The May edition of the Prescription medicine BPR update newsletter provides an update on the streamlined submission process.

In this edition:

  • progress under the streamlined submission process
  • PPF and submission dossier regulatory requirements
  • PI changes
  • industry workshops
  • IWG report.

The Prescription medicine BPR update newsletter (BPR update) reports on progress in the BPR program. Each month, the BPR update reports on the progress of the streamlined submission process. Each quarter, an update is provided on the PI/CMI project and the AusPAR project.

The TGA has announced the promotion of Harry Rothenfluh to the position of office head in the Office of Medicines Authorisation.

Streamlined submission process project

Progress to date

Item November December January Feburary March April May
Pre-submission planning forms
Date processing PPFs commenced 1 Nov 10 1 Dec 10 1 Jan 11 1 Feb 11 1 Mar 11 1 Apr 11 1 May 2011
PPFs received by processing date 28 34 24 25 27 33 28
S. 31 response - sponsor nominated 60 day 46% 68% 38% 48% 52% 61% 68%
Assessment status
Number incomplete 5 3 2 1 0 0 pending
Number withdrawn or deferred n/a 1 1 3 0 0 pending
Deficiencies (48 hours to address) n/a 4 3 6 8 8 pending
Progress to planning letter 23 30 21 21 27 33 pending
Application type
New entity - A 2 4 3 2 2 2 0
New fixed dose combination - B 0 1 1 1 0 0 0
Extension of indication - C 10 2 3 0 2 1 6
Generic - D 8 12 8 11 9 20 15
Minor variation - J, G, H 4 11 5 7 12 6 7
Major variation - F 3 2 1 4 2 4 0
(multiple application types) 2 with 3 2 with 2 3 with 2 - - - -
M1 - Outcome of pre-submission sent
M1 target date 15 Dec 10 15 Jan 11 15 Feb 11 15 Mar 11 15 Apr 11 15 May 11 15 Jun 11
Number met target date 23 30 21 4 18 33 pending
M2 - Outcome of submission consideration sent
M2 target date 31 Jan 10 28 Feb 11 31 Mar 11 30 Apr 11 31 May 11 30 June 11 31 Jul 11
Number withdrawn - 3a 3b 0 pending pending pending
Number deferred - - - 1e pending pending pending
Deficiencies (48 hours to address) 15 12 9d 6 pending pending pending
Number met target date 21 11 11 20f pending pending pending
Number effective notification letter 20 27 19c,d 20 pending pending pending
Number not effective notification letter 3 0 1 0 pending pending pending
  • a Includes 1 submission that was deferred until March 2011.
  • b Includes 2 submissions that were re-lodged for consideration in the February batch.
  • c Includes 1 submission that was deferred from the December batch.
  • d At the time of writing, the TGA is yet to decide on the effectiveness of 2 submissions with deficiencies.
  • e The TGA requested one sponsor to defer lodgement of submission until December due to dependency on outcome of evaluation of another submission.
  • f As notified to sponsors of February batch, notification of outcome of submission consideration would be delayed until 6 May 2011, due to Easter holidays and this delay would be absorbed in the 1st round assessment phase. All notification letters were issued on 6 May 2011.

Pre-submission planning form - regulatory requirements

The following information draws on common issues identified with PPFs submitted to date under the streamlined submission process. This information will assist sponsors in meeting the regulatory requirements of the streamlined submission process.

Problem TGA requirement
Approval of new ingredient

Where a sponsor wishes to register a new product that contains a new ingredient (one that is not on the TGA databases of ingredients and non-proprietary ingredients: AAN, AHN, ABN), it is a requirement that the process to approve a new ingredient for inclusion on the relevant databases must commence before lodgement of the pre-submission planning form.

The naming committees endeavour to approve ingredient names in twenty working days but this is not always possible if the process raises issues with the name or identification of the ingredient.

See -
Section of Transitional prescription medicine streamlined submission process January 2011.

Guidance for an effective submission

The following information identifies some requirements which are not being met, thereby risking that a submission will be considered not effective.

Problem TGA requirement
Submission dossier lodgement date

Sponsors should be aware a key outcome (MAR11/19) of the March meeting of the Industry Working Group was agreement the TGA would require the following submissions to be delivered one week earlier than the default timeline:

  • new chemical entity
  • new fixed combination
  • extension of indication.

Sponsors will be advised of the due date for submission dossier lodgement in the TGA planning letter.

See -
Section 4.1 IWG report of BPR update newsletter April 2011

Module 1.8.3 missing or incomplete

A common deficiency in submission dossiers is the failure to provide module 1.8.3 or to provide a module 1.8.3 that is compliant with requirements as established in CTD module 1.

Module 1.8.3 must:

  • be included for all submissions for which a PPF has been lodged
  • contain a declaration that either:
    • states that the submission is consistent with the PPF lodged, or
    • lists any inconsistencies with an appropriate explanation
  • identify how the sponsor has addressed any issues requiring sponsor action raised by the TGA in the planning letter.

See -
Module 1.8.3 of CTD Module 1 - Administrative information and prescribing information for Australia January 2011.

AUST R numbers

Where sponsors apply to vary the conditions of registration, or apply to make changes to the product information for an existing registration, the AUST R number for each affected product must be provided in the letter of application in module 1.0.1.

For clarity, the AUST R numbers may also be included in the 'label name' field in part C of the application form (in addition to other product details).

See -
Module 1.0.1 Letter of application of CTD Module 1 - Administrative information and prescribing information for Australia January 2011.

Packaging of submissions

When packaging a submission dossier, the boxes must be numbered sequentially and box 1 must contain volume 1 of module 1.

Box 1 must be clearly identifiable and accessible on the pallet. Remaining volumes and modules are to be packed sequentially.

See -
Packaging (p. 25) of CTD Module 1 - Administrative information and prescribing information for Australia January 2011.

Evaluation fees

Under subsection 23(2) of the Therapeutic Goods Act 1989, an application cannot be considered effective (and therefore accepted for evaluation) unless the prescribed application fee has been paid.

See -
The attached explanation of fees at the conclusion of this newsletter.

PI instrument changes

Appendix 8 of the ARGPM has been updated in response to changes introduced by the Restricted Medicine Specification 2011, and the Form for providing product information for a restricted medicine or other medicine in relation to which the Secretary requires product information to be provided.

These changes to the requirements for product information documentation took effect from 12 May 2011. Further information can be found under the legislative instruments section of the TGA website.

Industry workshops

The TGA, in partnership with ARCS, the professional development association for the therapeutic goods sector, will be conducting a second round of three-hour workshops on the streamlined submission process.

City Venue Date No. sessions
Brisbane Christie Conference Centre
Brisbane City
1 June 2011
Melbourne CQ Functions
Melbourne City
6 June 2011
Sydney Stamford Hotel
North Ryde
8 June 2011

The sessions will cover:

  • the streamlined submission process for the registration of prescription medicines
  • mandatory requirements, including requirements for the pre-submission, submission, and consolidate s.31 request phases
  • electronic dossier compilation
  • pre-submission planning form requirements for new chemical entity and generics through interactive case studies.

Further details, including the registration process, are available on the ARCS website under the 'Register for workshops' tab. Details were also provided in a letter sent to prescription medicines sponsors on 6 May 2011.

NeeS consultation closed

The period for consultation on Electronic format requirements for industry for providing regulatory information: Non-eCTD electronic submissions (NeeS) for human medicinal products has closed. The TGA will be considering comments received during the consultation process and will discuss the publication at the next Industry Working Group meeting to be held in June.

The next version of the document, incorporating feedback received during the consultation process, will be mandatory from 1 July 2011. Sponsors should note submission dossiers lodged under the streamlined submission process must still be lodged in paper and electronic format. The paper format remains the formal dossier.

New TGA website

On 4 May, the TGA launched its new website. The redesigned website aims to improve the navigation and organisation of content. Under the new design, information on the streamlined submission process can be found under the standards, guidelines and publications section of the industry prescription medicines page.



IWG report

The Industry Working Group (IWG) met on 19 April 2011. The summary below provides information on actions and outcomes arising from the meeting.

1 - Introduction and overview


The chair welcomed the following to the meeting:

Industry Members TGA

Susan Alexander (ROCHE)
Warren Back (MERCK)
Helen Critchley (SANOFI-AVENTIS)
Elizabeth de Somer (MA)
Damien Gallagher (ASCENT PHARMA)
Kirpal Kaur (BMS)
Kate Lynch (GMIA)
Duncan Purvis (JNJ)
Piety Rocha (ALPHAPHARM)
Mark Rowland (AMGEN)
Fiona Klass (ASPEN)
Sonja Cuce (HOSPIRA)
Liling Xie (GenRX)

Harry Rothenfluh (HR)
Donna Daniell (DD)
John Donohoe (JD)
Leanne McCauley (LM)
Fiona Allen (FA)
Vicki Grant (VG)
Sherif Elnaggary (SE)
Klara Koelmeyer (KK)
Iain Brown (Records) (IB)
Anne Slaney (AS)
Peter Bickerton (PB)


Review of the previous outcomes summary

The IWG reviewed the status of the outcomes from the March meeting.

Action Apr 11/1 - The outcomes summary was approved for the March meeting when amended as follows:

  • Mar 11/1 - change Signet to Aspen
  • Mar 11/2 - reword to better reflect outcome of discussions.

Action Apr 11/2 - The TGA to present a revision to the IWG terms of reference for the next meeting. MA to assist. Terms of reference to reflect expectations of role of the IWG beyond the current duration of the transition phase for the streamlined submission process.
(Note action Apr 11/14)

2 - Items for noting

Status Report

The IWG considered the tabled qualitative and quantitative report for milestone 1 and 2 performance to date.

Action Apr 11/3 - The TGA to include routine reporting, by application type of milestone dates, in accordance with following categories:

  • default
  • planned
  • revised planned (as communicated to sponsors at each milestone)
  • actual.

TGA to include quantitative data on milestone 3 extensions.


The IWG expressed concern about number of sponsors (42) who have failed to respond to the back capture work of the TGA.

Action Apr 11/4 - The TGA to secure advice on removal of ARTG listing for products where sponsor fails to provide PI/CMI.

3 - Streamlined submission

Physical dossier quality

The IWG noted the importance of physical dossier quality to the success of the new process and TGA's current experience where approximately 20% of submissions do not meet the regulatory requirements. The IWG discussed the range of barriers to sponsors delivering high quality physical dossiers (education, guidelines, lack of incentives, change management) and advised the following.

Action Apr 11/5 - The TGA to implement the following new arrangements from 1 July 2011:

  • planning letters to advise sponsors of the due date for submission, but also highlight the positive benefits of submitting as early as possible to allow greater time to address potential dossier quality issues impacting on submission processing in accordance with the default timelines
  • submissions to be received with a signed checklist (as amended by the IWG) from sponsors declaring the dossier complies with the consolidated list of TGA's mandatory requirements for physical dossier quality and presentation at the time of dispatch
  • submission dossiers to be held separate to TGA official records (i.e. not accepted by TGA for processing) until they meet the mandatory physical condition and presentation criteria
    • TGA to advise sponsors if submission does not meet requirements and the actions necessary to correct issues. This includes impact on default timelines, noting that corrections requiring more than 2 working days will result in the submission being considered not effective
    • TGA to advise sponsor on arrangement for collection OR replacement of folders as required
  • Communication of the new mandatory requirements to follow previously agreed standards as follows:
    • revised regulatory and supporting documents to be available on TGA website 4 weeks prior to mandating date
    • sponsors notified of change in BPR update, TGA website updates and planning letters.

The IWG advised TGA of their expectations that a full transition plan for the introduction of eCTD is developed as soon as possible. The plan is needed to inform incremental decisions about the steps for migrating sponsors from paper to electronic submission development and lodgement.

3.2 General review - Performance to date

General business rules review

The IWG discussed a range of issues that require clarification for sponsors and advised the following.

Action Apr 11/6 - The TGA to communicate the specific appeal rights of sponsors in relation to the TGA's consideration of NOT COMPLETE and NOT EFFECTIVE at milestone 2.

Action Apr 11/7 - The TGA to update the PPF and supporting documents to ensure sponsors are aware of the requirements for study completion. For example, if the study is not complete at time of PPF submission but a justification is included, will the PPF be considered complete?


The IWG advised of their expectations that through the transition process the TGA continues to strengthen the rejection of submission dossiers that are not complete or of a high quality in accordance with the pre-submission and submission process requirements. However, the IWG recognised that this outcome is contingent on robust regulatory guidelines that educate and clearly inform sponsors of the regulatory requirements.

Action Apr 11/8 - The TGA to urgently build capacity to finalise the update to a new ARGPM that incorporates all the regulatory and supporting documents generated to support the streamlined submission process.

Action Apr 11/9 - The TGA to consider offer by the IWG to form a working group to support the development of the ARGPM and to consider previous feedback on the requirements for a new ARGPM.

Predictable timeframes

The IWGexpressed concern that the key outcome of predictable timelines in accordance with the default milestone dates was not always being achieved during the transition process and that this was central to the commitment by industry.

The TGA confirmed its strong commitment to predictability. However, highlighted that there is a range of variables that impact on TGA's capacity to always deliver in accordance with the default timelines and that there is a need to engage industry around the process to ensure transparency about the reasons for variations to the default timelines. Predictable timelines need to be based on a set of agreed assumptions/parameters, for example:

  • relevant to individual submission - TGA capacity to manage x level of complexity, size, issues that emerge during evaluation. If level exceeded, timelines can no longer apply.
  • relevant to overall volume - TGA capacity to manage x submissions per period. If a higher number lodged, default timelines can no longer apply.

Action Apr 11/10 - The TGA to strengthen general and specific submission communication to sponsors about the reasons for initial or subsequent variation to the default milestone dates. Communication to include expectations that the sponsor is able to adjust the milestone 4 dates (30 or 60 days) in response to changes to the expected default timelines.

Milestone 1/milestone 2 review

The IWG noted that 6 batches of milestone 1 (pre-submission phase) and 3 batches of milestone 2 (submission phase) have been completed, and that this experience will inform a review of these milestones, and importantly put into context a range of issues and proposed responses.

Action Apr 11/11 - The TGA to coordinate a milestone 1 and 2 review to include consideration of:

  • achievements against the key principles of consistency, quality, and coordination
  • opportunities to provide further clarity on pre-submission information requirements, for example, templates for module 2
  • clarification of whether the TGA is evaluating or assessing during these phases
  • current handling of deficiencies and the perception the TGA is continuing to 'massage submissions' rather than considering submissions not effective and not accepted for evaluation if they do not meet the regulatory requirements
  • adequacy of guidelines and clarity of mandatory requirements
  • comparison between TGA and EU process and timelines for pre-submission.

ACPM/PBAC parallel processing

The IWG considered a range of matters relating to the feasibility of monthly ACPM meetings including the TGA's timely access to relevant expertise, projections of workload, and cost/quality/benefit impacts. The IWG noted the TGA's current strategies including the expansion of the ACPM membership, the reinstating of the core membership, and the review of the PSC. The IWG highlighted the importance of aligning the timelines for the outputs from the TGA and inputs to the PBAC processes. The TGA confirmed its commitment to enable the goal of parallel processing.

Action Apr 11/12 - The IWG supports the continuance of bi-monthly ACPM meetings, pending the successful resolution of a reliable mechanism for predictable delivery dates for the delegate overview (or equivalent report), set as a separate milestone date.

Action Apr 11/13 - The TGA to provide a diagram illustrating the alignment between the TGA streamlined submission process and PBAC processing timelines.

End of transition

The IWG discussed expectations of the conclusion of the current 12-month transition period and noted that in November 2011 it will be too early to lock in full final arrangements as only part of the first batch will have completed all milestones. Members agreed that it might be reasonable to lock in pre-submission and submission phases at this time and that plans should be in place to achieve this outcome as a project milestone at November 2011.

The IWG again emphasised the importance of delivering predictable timelines.

Action Apr 11/14 - IWG members to consider expectations for transition conclusion and how predictable timeframes could be based on a set of agreed assumptions/parameters, for example:

  • relevant to individual submission, for example, complexity, size, other issues that emerge during evaluation
  • relevant to overall volume, for example, TGA capacity to manage x submissions per period and if a higher number are lodged, default timeframes can no longer apply.

Action Apr 11/15 - The TGA to plan to present at CEO forums for MA and GMiA, findings from the transition period, including discussion on the impact on TGA resourcing and fees arrangements that will support the TGA to commit to predictable timeframes.


Review of communication activities
Confirming June 2011 sponsor education workshop plan

Action Apr 11/16 - The IWG to approve the training agenda. Agenda to be based on response to the evaluation from previous sessions (including better venues) and cover:

  • speaking role for IWG member
  • review of MS1 and MS2
  • detail for management of MS3 - 8
  • key areas of deficit for sponsors
    • physical dossiers
    • rights and responsibilities of sponsors
    • mandatory requirements.

Action Apr 11/17 - The TGA and IWG members to follow up with ARCS on the TGA's proposal to deliver keynote address and workshops for the September conference.

5 - Next meeting

Tuesday 21 June 2011

Agenda items:

  • progress with old process submissions
  • transition close arrangements
  • post-education workshop review
  • MS2 and MS3 review.

Tuesday 23 August 2011

Tuesday 25 October 2011


The following information is provided as a guide to sponsors in relation to fees.

Type Action Comments
Application seeks registration of a designated orphan drug Submission is lodged without payment. Letter of application should note that no evaluation fees are being provided due to orphan drug designation.

Sponsors must identify the orphan drug status in the pre-submission planning form and attach one of the following:

  • gazettal of orphan designation
  • copy of letter approving orphan designation
  • email from the clinical delegate advising of approval of orphan designation.

The notification letter for the submission will confirm the waiving of the evaluation fee under orphan drug provisions, as applicable.

Application lodged electronically via eBS Ensure payment is made by the due date specified on the invoice generated by eBS. Sponsors must also send a copy of the invoice with their payment. Applies to new chemical entities, new fixed combinations, and new generic medicines only.
Extension of indication applications

In accordance with Appendix 2 to the ARGPM, sponsors may request that they are invoiced for the evaluation fee where it exceeds $100,000.00.

To request an invoice, sponsors must include the request in the letter of application with the submission dossier.

All other applications and submissions Payment of evaluation fees must be made at the same time as submission lodgement, in accordance with Appendix 2 of the ARGPM.

Payment must be accompanied by the application form and letter of application.

See -
3.2 Submission of applications in the ARGPM.

Where payment is made by direct funds transfer, advice must be sent to the TGA advising that payment has been made, quoting the submission ID and reference used for the funds transfer.

Contact the BPR team

PO Box 100
Woden ACT 2602

© Commonwealth of Australia 2011

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