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Prescription medicine BPR update newsletter, April 2011
The April edition of the Prescription medicine BPR update newsletter provides an update of the three projects under the Business Process Reform Program.
In this edition:
- Streamlined submission process (SSP)
- Product information/consumer medicine information (PI/CMI)
- Australian Public Assessment Records (AusPAR)
- Industry Working Group report
- Consultation on electronic submission dossier requirements.
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.
Streamlined submission process project
Progress to date
|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|
|PPFs received by processing date||28||34||24||25||27||33|
|S. 31 response - sponsor nominated 60 day||46%||68%||38%||48%||52%||61%|
|Number withdrawn or deferred||n/a||1||1||3||pending||pending|
|Deficiencies (48 hours to address)||n/a||4||3||6||pending||pending|
|Progress to planning letter||23||30||21||21||pending||pending|
|New entity - A||2||4||3||2||2||2|
|New fixed dose combination - B||0||1||1||1||0||0|
|Extension of indication - C||10||2||3||0||2||1|
|Generic - D||8||12||8||11||9||20|
|Minor variation - J, G, H||4||11||5||7||12||6|
|Major variation - F||3||2||1||4||2||4|
|(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|
|Number met target date||23||30||21||4||pending||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|
|Deficiencies (48 hours to address)||15||12||9@||pending||pending||pending|
|Number met target date||21||11||11||pending||pending||pending|
|Number effective notification letter||20||27||19*@||pending||pending||pending|
|Number not effective notification letter||3||0||1||pending||pending||pending|
- # Includes 1 submission that was deferred until March 2011.
- § Includes 2 submissions that were re-lodged for consideration in the February batch.
- * Includes 1 submission that was deferred from the December batch.
- @ At the time of writing, the TGA is yet to decide on the effectiveness of 2 submissions with deficiencies.
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.
|Draft comprehensive table of contents||
Sponsors must attached a draft comprehensive table of contents to the pre-submission planning form (PPF). It must:
The full details of each reference are required for the TGA to determine whether or not evaluation is required, and if so, to assess the resources required to undertake the evaluation.
Guidance for an effective submission
The following information identifies some regulatory requirements which are not being met, thereby risking that a submission will be considered not effective.
|Module 1 compliance||
In September 2010, the TGA released a revised CTD Module 1 that:
The January 2011 version included minor corrections and further clarifications.
The TGA has processed three batches of submission dossiers under the streamlined submission process and has noted a large proportion of submissions do not comply with the revised CTD Module 1 requirements.
Sponsors should ensure they are familiar with the revised CTD Module 1 - January 2011 and their submission dossiers comply with this version.
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:
|Choice of media - CD or DVD||
For the electronic copy of the submission dossier:
|Electronic copy submission dossiers||
The TGA has received a number of electronic copies of submission dossiers which are missing data.
In the letter of application, sponsors declare the electronic copy of the submission dossier is identical to the paper copy and should ensure this is the case before lodging their submission dossier.
The PI/CMI project seeks to improve access for consumers and health professionals to information about prescription medicines by providing a single trusted internet source for product information (PI) and consumer medicine information (CMI) documents.
To achieve this, the TGA collects the following:
- PI documents for all prescription medicines registered on the Australian Register of Therapeutic Goods (ARTG), whether they are marketed or not 1
- CMI documents for all registered prescription medicines on the ARTG that are being marketed in Australia.
In addition to supplying PI and CMI documents for existing registrations, it is a requirement that sponsors lodge PIs and CMIs with the TGA following approval of applications for new and varied products. The requirements for PI and CMI lodgement are identified in the approval letter and can also be found on the page on the TGA website. Lodgement of PI and CMI documents must be completed electronically via the secure eBS facility or healthlinks.net.
Published PI and CMI documents are available on the TGA eBS website under 'Public TGA information'.
- The TGA acknowledges there are a number of registered prescription medicines which, for a range of legitimate reasons, may not have a PI, for example, grandfathered products.
The following table shows progress in collecting PI and CMI documents as at 30 March 2011.
|As percentage of prescription medicine entries on ARTG|
|January 2011||March 2011|
|Total ARTG entries||10,043|
Key areas for sponsors
Lodging an updated PI
The TGA is receiving inquiries from sponsors who have lodged an updated PI using the replace function but cannot see the updated PI on the TGA eBS PI/CMI facility. This happens when the 'replace' draft has not been lodged correctly. When not lodged correctly, TGA eBS creates a draft which is automatically saved in the 'draft view'. To locate the previously lodged PI document, sponsors must open the draft from the drafts view by selecting ‘view drafts’ from the ‘portal’ drop-down menu. The sponsor must then either:
- check the draft information, attach the current PDF document, validate, and then lodge
- delete the PI, then complete the replace process by using the 'replace' option which will now be visible.
If sponsors are unable to locate their previously lodged PI under the drafts view, they should then contact the TGA for further advice.
PI - for publication/not for publication
For all prescription medicines registered on the ARTG, product information (PI) must be uploaded and marked 'for publication' (for prescription medicines currently being marketed), or 'not for publication' (for prescription medicines currently not being marketed). This requirement for a PI does not apply to grandfathered products.
Outstanding PI and CMI documents
To date, the TGA has completed telephone contact with each of the 55 sponsors who have failed to lodge PI and CMI documents. Forty sponsors have yet to submit the documents, or to advise on reasons for being unable to submit the required documents. In accordance with the advice from the Industry Working Group, the TGA is reviewing mechanisms to ensure compliance from the sponsors with outstanding documents.
AusPAR progress to date
The following table provides an update on AusPAR progress to 31 March 2011.
|January 2011||March 2011|
|Released on TGA website||74||102|
|With sponsors for comment||4||7|
Waiting for either:
|Initial draft complete and waiting for the delegate's decision||16||6|
|Undergoing final internal TGA quality assurance review||12||7|
The TGA will undertake a consultation process shortly to canvass views on some of the issues concerning AusPARs, including format and scope of the AusPAR, sponsor compliance with the two week period for comment, commercially confidential material, and a shared understanding of the scope of response for sponsor review.
Further information will be provided on the TGA website and in the BPR Update.
The following table summarises the draft actions and outcomes arising from the 7 March 2011 Industry Working Group (IWG) meeting.
|1 - Introduction and overview of previous actions|
IWG reviewed the actions from previous meeting:
Action Mar 11/1 - IWG Membership. TGA to clarify status of the involvement of Ausbiotech on IWG. Members noted the new members from Aspen, Hospira and Apotex. Members noted that under the terms of reference, IWG members are not representative of sponsors and substitute persons are not encouraged.
Action Mar 11/2 - IWG agreed that separate sub-working group role in developing a module 2 equivalent template will be progressed at the next meeting in the broader context of M1 and M2 review. IWG agreed that the current '6 month' clearance for GMP be reviewed later in the transition phase.
Action Mar 11/3 - TGA to present qualitative and quantitative performance measures to IWG at next meeting.
|2 - BPR program items for discussion/ noting|
IWG considered progress with AusPARs since commencement in Nov 2009 and the need for consultation to inform the further development of this initiative, and agreed the following:
Action Mar 11/4 - TGA to commence consultation (with consumers, health professionals, and industry) on AusPARs to seek advice on the following:
Action Mar 11/5 - TGA to conduct consultation in readiness for a report on outcomes to IWG at June meeting.
IWG noted the outcomes from the 2nd round of back capture, however were concerned that 55 of the targeted 118 sponsors have yet to comply.
Action Mar 11/6 - IWG advised TGA to explore options for taking steps to cancel ARTG registration for products where sponsors do not submit PI/CMI information in response to TGA request letter.
Action Mar 11/7 - TGA to explore options to accurately account for legitimate absence of PI/CMI information - i.e. for products not marketed, grandfathered products, and remove from the target goal.
Action Mar 11/8 - Goal for June 2011to achieve 100% PI and 80% CMI, noting the removal of documents that cannot be provided.
IWG noted and welcomed the progress of consultation with industry on the new fee arrangements to align with the new streamlined submission process.
|3 - Streamlined submission|
IWG discussed the performance and issues identified through the first 4 months of the streamlined submission process. Overall IWG agreed that the new process was on track and was meeting expectations, with minor areas for review and refinement. A key issue for consideration is the clarity of expectations and the delineation of assessment versus evaluation activities.
Action Mar 11/9 - TGA to staff coordination team to full capacity to improve the delivery of coordinated and consistent communication with sponsors.
Proposed changes to TGA processes (pending internal advice and noting that these arrangements are only intended to support sponsors during the transition phase)
Action Mar 11/10 - Single administration deficiency assessment - Upon receipt, the PPF will be assessed by TGA’s administrative staff. Where deficiencies are identified, the TGA will contact sponsors by phone seeking clarification or provision of required documents to the required standard (e.g. signatures). Sponsors will be advised of the requirement to provide a single response, which is acceptable to the TGA, within a two working day timeframe or risk the PPF being considered not complete.
Action Mar 11/11 - Single scientific/guidance deficiency assessment - Upon completion of the administrative assessment, the PPF will be assessed by the TGA's scientific staff. Prior to issuing a planning letter (week 6), where deficiencies are identified, the TGA will contact sponsors by email (week 5) seeking clarification or provision of required documents to the mandatory standard.
Action Mar 11/12 - Justifications - The declaration to be updated so that in lodging the PPF, the sponsor declares that:
Note - advice from the TGA in the planning letter provides information on issues a sponsor is encouraged to address before lodging the submission dossier. It does not indicate that the information (or justifications) will be considered favourably during the evaluation.
Action Mar 11/13 - TGA to continually review and improve clarity of requirements through the development of the guidance documents.
Changes to the PPF/regulatory/guidance documents/templates
PPF form/help notes - Action Mar 11/14 - TGA to make the following changes:
Mandatory requirements for pre-submission phase - Action Mar 11/15 - To support transparency and consistency, TGA to develop mandatory requirements for considering PPF complete.
Q&A - Action Mar 11/16 - Fixed dose combinations
Action Mar 11/17 - Trade names - TGA to update Q&A page to clarify process on trade names:
Planning letter - Action Mar 11/18 - TGA to amend the template for planning letter to include:
The IWG noted the significant constraints on the TGA in meeting the milestone 2 requirements within the 10 calendar day timeframe and discussed possible options to adjust the milestone dates between M1, submission delivery, and M2. Members noted the key issues are:
The TGA noted the proposal from Medicines Australia that a central assessor function would improve timelines and consistency. However, the TGA advised this model excludes access to the correct expertise for assessing a submission, and would have the effect of disabling TGA’s evaluation planning.
The IWG agreed that the following actions are to be implemented with a view to monitoring impact on this milestone.
Action Mar 11/19 - The TGA to mandate lodgement of A, B, C submissions types one week earlier (8th of month). The TGA will remove reference to early delivery of large and complex submissions (but retain this size reference when in the context of M3 timelines).
Action Mar 11/20 - The TGA to implement increased focus on quality submissions at the M1 phase (see above recommendations regarding justifications).
Action Mar 11/21 - The TGA to remind sponsors of the mandatory requirements for physical and electronic submission dossier delivery. Failure to meet these requirements will result in a submission being considered not effective and not accepted for evaluation.
The IWG noted examples of inaccurate volume number statements and the significant impact this has on TGA planning and resourcing. The IWG advised that migration to page numbers was not feasible.
Action Mar 11/22 - TGA to continue the current arrangements for considering submissions to be not effective when there is a deviation from the planned versus actual submission and that sponsors are accountable for:
Electronic dossier requirements
The IWG agreed on the importance of electronic dossiers to the success of the streamlined submission process and noted the status of the proposed NeeS regulatory and supporting documents. Members highlighted their concerns about industry readiness to comply.
Action Mar 11/23 - The TGA to advise on inclusion of XML based NeeS dossier as an option for the mandatory electronic dossier requirements. IWG to provide a sample of this format.
Action Mar 11/24 - The TGA to conduct industry consultation on the NeeS document with the support of Medicines Australia and GMIA, with a view to confirming industry readiness for a mandatory compliance date of 1 July 2011.
Action Mar 11/25 - The TGA to revise NeeS document to include clearer articulation of this requirement as a step towards fully electronic dossiers; outcome of XML acceptance will be included in the outcomes of the consultation process.
Action Mar 11/26 - The TGA to amend template for notification letter to include any further detail for reasons for a variation to milestone target dates.
Milestone 3 - Consolidated s. 31 request
The IWG noted the issues identified in the report on the trial consolidated s. 31 request and that the TGA is on schedule to deliver this milestone on 30 May 2011 for the first batch of submissions.
Action Mar 11/27 - TGA to include standard text in planning letter to remind sponsors to ensure all parties (such as DMF holders) are prepared to respond to a s.31 request within the sponsor-designated timeframe.
The IWG discussed the need for clarification of business rules for milestones 4-8 and in particular sponsor expectations when a milestone activity is not required, for example where no advisory committee is required or no s. 31 request is issued. The TGA advised it cannot commit to an automatic 'rolling up' of the milestone dates and advised the IWG of the following arrangements for delivery of predictable timeframes for sponsors.
Action Mar 11/28 - During the transition period as the TGA monitors implementation of the streamlined submission process, at each milestone, the TGA will deliver to sponsors a formal letter that:
The TGA will capture qualitative and quantitative data that illustrates the planned versus actual performance.
Advisory Committee (optional milestone 6)
The IWG discussed the status of ACPM meetings for 2011 and in particular the timing for implementation of the proposed monthly meetings. The TGA advised:
Action Mar 11/29 - TGA to provide the IWG with detailed information to inform the decision at the next meeting about the relative cost/benefit of more frequent meetings of the ACPM to support registration decisions, particularly the ability to secure the necessary expertise on a more regular basis.
The IWG agreed to the proposed revisions to transitional Mandatory requirements for an effective submission including:
Action Mar 11/30 - TGA to deliver a document to IWG including the following revisions for 1 June 2011 commencement:
Communications and education activities
Performance and transparency
The IWG congratulated the TGA on the newsletter and its value in sponsor engagement and awareness of issues. No changes to current arrangements were recommended.
The IWG noted the TGA’s response to issues for the generics industry and the generic sponsor training session scheduled for Tuesday 8 March 2011. The IWG agreed upon the arrangements for the next road show training in June 2011.
Action Mar 11/31 - TGA to plan the next sponsor training as follows:
|4 - Other business|
Delivery of formal letters to sponsors
The IWG agreed to explore opportunities to migrate sponsors to secure email/electronic delivery of the planning/notification/s. 31 letters (current arrangement is for faxing of these letters). However it was noted that this was only feasible when all sponsors have the same functionality.
Action Mar 11/32 - TGA to explore feasibility of eBS providing platform for secure email deliver of letters to sponsors.
Action Mar 11/33 - TGA to communicate by newsletter the arrangements for secure email to sponsors (including steps for sponsors to register).
Transition evaluation plan
The IWG agreed that details of the post transition arrangements need to be considered and informed by an independent evaluation (together with the ongoing internal qualitative/quantitative data capture).
Action Mar 11/34 - TGA to deliver at the next meeting, details of the scope of an independent evaluation of the streamlined submission process.
|5 - Next meetings|
Tuesday 19 April 2011
Tuesday 21 June 2011
Tuesday 23 August 2011
Tuesday 25 October 2011
Electronic dossier consultation
The TGA invites comment on the proposed mandatory requirements for electronic submission dossiers lodged under the streamlined submission process. Full details on the consultation process, including the draft regulatory requirements are available at www.tga.gov.au. The consultation period is now open and will close on 1 May 2011. It is the intent of the TGA to mandate the regulatory requirements from 1 July 2011.
Contact the BPR team
PO Box 100
Woden ACT 2602
- Telephone: 02 6232 8250
- Facsimile: 02 6232 8140
- Email: firstname.lastname@example.org
- Email: email@example.com (for current PPFs and submissions under streamlined process)
© Commonwealth of Australia 2011
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