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Prescription medicine BPR update newsletter, July 2011
The July 2011 edition of the Prescription medicine BPR update newsletter provides an update on the streamlined submission process, the PI/CMI project, and the AusPAR project.
In this edition:
- TGA reports on milestone 3 progress
- regulatory requirements under the streamlined submission process
- PI/CMI progress
- AusPAR progress
- changes to fee arrangements.
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
Summary of progress to date
The following is a summary of progress to date under the streamlined submission process. For a full record of progress to date under the streamlined submission process, see the Attachment.
- Attachment: Streamlined submission process project - Progress to date (pdf,230kb)
- Attachment: Streamlined submission process project - Progress to date (Microsoft Word,46kb)
|Pre-submission planning forms|
|PPFs received by processing date||28||34||24||25||27||33||28||29||35|
|Number not complete||5||3||2||1||0||0||1||pending||pending|
|M1 - Outcome of pre-submission sent|
|Number withdrawn or deferred||0||1||1||3||0||0||0||pending||pending|
|Progress to planning letter||23||30||21||21||27||33||27||pending||pending|
|M2 - Outcome of submission consideration sent|
|Number withdrawn or deferred||1||4||1||1||0||3||pending||pending||pending|
|Number effective notification letter||21||27*||20*||20||27||29||pending||pending||pending|
|Number not effective notification letter||1||0||1||0||0||1||pending||pending||pending|
|M3 - Section 31 request for information|
|Number with s.31 request for information||19||10||pending||pending||pending||pending||pending||pending||pending|
|Number of individual questions/requests||481||251*||pending||pending||pending||pending||pending||pending||pending|
|M4 - End of s. 31 response period|
|M4 default date - 30 day response period||30 Jun 11||31 Jul 11||31 Aug 11||30 Sep 11||31 Oct 11||31 Nov 11||31 Dec 11||31 Jan 12||pending|
|Number responses expected||10||pending||pending||pending||pending||pending||pending||pending||pending|
|Number responses received by due date||9||pending||pending||pending||pending||pending||pending||pending||pending|
|M4 default date - 60 day response period||31 Jul 11||31 Aug 11||30 Sep 11||31 Oct 11||31 Nov 11||31 Dec 11||31 Jan 12||29 Feb 12||pending|
|Number responses expected||4||pending||pending||pending||pending||pending||pending||pending||pending|
|Number responses received by due date||pending||pending||pending||pending||pending||pending||pending||pending||pending|
- * Partial data for December batch - represents submissions from December 2010 batch with default timelines. Complete December data (including figures from December 2010 batch submissions with extended milestone 3) to be published next issue.
- # Includes one submission deferred from previous batch.
Pre-submission planning form - regulatory requirements
The following information draws on common issues identified with pre-submission planning forms (PPF) lodged to date under the streamlined submission process. This information is provided to help sponsors meet the regulatory requirements of the streamlined submission process. If a PPF does not meet regulatory requirements, it will be considered not complete and not acceptable.
|Guidance for sponsors - pre-submission planning forms|
|Inconsistency in indications||Sponsors must ensure proposed indications are identical across all documents supplied in the pre-submission phase. The TGA has received a significant number of PPFs where the indications listed are not consistent with those in the draft product information document and other supporting documents supplied with the PPF.|
|Incorrect version of PPF||
Sponsors must ensure they are lodging the correct version of the PPF. During the transition period, the PPF has been updated to reflect changes introduced by the streamlined submission process.
The PPFs loaded on the TGA website are clearly labelled with the dates for which they are applicable. Sponsors can find the correct version on the forms for prescription medicine sponsors page under the 'prescription medicines' tab in the industry section of the TGA website.
The current version of the form is prescribed by the Section 23 instruments detailed under the legislation and legislative instruments section of the TGA website.
|Information about risk management plans||
Sponsors must indicate on the PPF whether a risk management plan (RMP) will be included in the submission dossier. If the sponsor does not intend to include an RMP, an acceptable reason must be provided in the PPF.
The TGA has received a number of PPFs where the sponsor has indicated an RMP will not be included in the submission dossier but the sponsor has not provided an acceptable reason for its intended omission. If an RMP is not required for the particular submission type, this is to be noted in the appropriate section of the PPF.
|Module 2 or equivalent requirements for new generic medicines||
The following CTD documents must be provided for submissions to support an application to register a generic medicine:
These documents, or equivalent information, must be provided with the PPF for generic medicine applications.
|Module 2 requirements for changes to product information||
Where the application involves a change to product information based on clinical trials, modules 2.5 and 2.7 must be provided.
Where sponsors are seeking to change product information on the basis of other data, they should email email@example.com prior to lodging a PPF for advice on regulatory requirements.
Literature references are often included in an application. The CTD format specifies where these references are located, namely modules 2.5.7, 2.7.5, 3.3, 4.3, and 5.4. If any of these sections appear in a table of contents submitted with the PPF, the full bibliographic details of all of the references in these sections of the submission dossier must be included in the table of contents.
At a minimum, the following information for each literature reference must be listed in the table of contents:
Furthermore, the TGA will need to undertake detailed evaluation of references where sponsors are either:
In such cases, sponsors must list all references in a separate bibliography titled 'module 4 literature to be evaluated' and 'module 5 literature to be evaluated'. Alternatively and if appropriate, the references may be included in the relevant sections of the 'tabular listing of all clinical studies' (module 5.2) and 'non-clinical tabulated summaries' (module 2.6).
The TGA requires this information to assess the scope and scale of the submission and will update the relevant guidance documents to make this requirement explicit.
Guidance for an effective submission
Submissions that do not meet the following regulatory requirements may be considered by the TGA to be not effective and not accepted for evaluation.
|Guidance for sponsors - submission dossiers|
|Mandatory electronic lodgement||
Sponsors must electronically lodge their submission through eBS prior to sending the submission dossier to the TGA.
In this context, 'electronic lodgement' means the sponsor has created an application in eBS and subsequently printed out an application form and an electronic lodgement cover sheet for inclusion in module 1 of the submission dossier. Electronic lodgement in this context does not mean the submission dossier has been lodged electronically.
All new chemical entity, new fixed combination, and new generic medicine submissions must be lodged online via eBS before the submission dossier is sent to the TGA.
Sponsors must provide appropriate sterility information in submission dossiers supporting applications to register sterile medicines.
|Addressing issues notified in the planning letter||
The TGA planning letter contains information on the lodgement date for the submission dossier and expected dates for the milestones of the regulatory process. It also states the scope of the submission the TGA expects to receive, and lists any issues the TGA has identified when considering the PPF which need to be addressed in the submission dossier.
Sponsors must identify in the submission dossier (module 1.8.3) how they have addressed any issues identified by the TGA in the planning letter.
Any sponsor who finds any errors in, or has questions about, the planning letter should notify the contact point identified in the letter immediately.
Understanding the streamlined submission process
The TGA has received a number of questions from sponsors about the streamlined submission process itself, as distinct from PPF and submission dossier requirements. The TGA provides the following information to assist sponsors better understand details of the actual process. Sponsors should also consult Transitional prescription medicine streamlined submission process for further information.
|Explaining the streamlined submission process|
|Extension of milestone 3 default timeframe||
The TGA planning letter contains the milestone dates for the regulatory process. The TGA has discussed milestone dates on several occasions with the Industry Working Group and noted during the transition period that there may be some amendments to the proposed milestone dates as sponsors and the TGA become familiar with the new process.
In a limited number of situations the TGA may need to delay the completion of milestone 3 (Outcome of 1st round assessment sent to sponsor). This may be required because the TGA is having difficulty securing an external evaluator, or because a complex submission requires additional time for evaluation.
Sponsors may be notified of a delay of milestone 3 in the planning letter (following PPF consideration), the notification letter (following acceptance of the submission dossier), or in an amendment letter.
In some cases, after advising the sponsor in the planning letter that there will be a delay at milestone 3 because of difficulties in securing an evaluator, the TGA has been able, between milestones 2 and 3, to secure an external evaluator who is able to complete the evaluation work within the required timeframe. In such cases, the delay to milestone 3 is reduced and the sponsor is advised in the notification letter.
|Making inferences from the nature of the section 31 request||
The TGA has now issued the first round of section 31 requests for information. The purpose of the section 31 request is to provide evaluators with further information to inform their evaluation and recommendation to the delegate. It is possible that requests will not be issued for each area or module of the submission dossier. If sponsors do not respond to a request for information, evaluators complete the evaluation based on the information provided in the submission dossier.
Information requested in a s31 request, or the absence of a s31 request should not be taken as an indication of the outcome of the TGA’s assessment. Sponsors can expect to receive an indication on the likely outcome of their application at milestone 5 when they receive the evaluation reports from the TGA.
Sponsor education and training
In early June, the TGA held workshops for industry in Brisbane, Melbourne and Sydney. The workshops were designed to provide information on the streamlined submission process, particularly milestone 3, as well as electronic dossier compilation, and PPF requirements for new chemical entities and generics. The workshops were positively received with the majority of participants indicating in the evaluation survey (administered by ARCS) that the workshops met or exceeded their expectations.
Risk management plans
The TGA has updated the Q&A document for risk management plans. The Office of Product Review is currently reviewing submissions received during the consultation on RMP requirements. The outcome of this consultation will be published when it is finalised. For further advice on RMPs, contact firstname.lastname@example.org.
The PI/CMI project will 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 not1
- 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, sponsors must lodge PIs and CMIs with the TGA following approval of applications for new and varied products. 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 June 2011.
|Publication of PI/CMI documents|
|Document||As percentage of prescription medicine entries on ARTG|
|January 2011||March 2011||June 2011|
|Total ARTG entries||10,043||10,125|
New form for PI
As advised in the May BPR update, changes to the regulatory requirements for product information documentation came into effect on 12 May 2011 with the registration of the Restricted Medicine Specification 2011. This instrument specifies the medicines or classes of medicine that are 'restricted medicines' and thus require the inclusion of draft product information documentation in the submission dossier. The form in which this information must be provided, approved under subsection 7D(1) of the Therapeutic Goods Act 1989, is detailed under the Form for providing production information section of the TGA website. Product information in the approved form must be provided in relation to applications for other medicines where required by the Secretary in writing to do so.
Appendix 8 of the Australian regulatory guidelines for prescription medicines has been updated to reflect these changes. The TGA has also developed a Product information - questions and answers page on the TGA website to assist sponsors with these minor changes.
AusPAR progress to date
The following table provides an update on AusPAR progress to 31 March 2011.
|January 2011||March 2011||June 2011|
|Released on TGA website||74||102||116|
|With sponsors for comment||4||7||6|
Waiting for either:
|Initial draft complete and waiting for the delegate's decision||16||6||-|
|Undergoing final internal TGA quality assurance review||12||7||10|
Amendments to the therapeutic goods legislation
Legislative changes in relation to fees payable to the TGA came into effect on 1 July 2011. These changes apply to a range of applications for the registration of a prescription medicine on the Australian Register of Therapeutic Goods and the variation of an existing prescription medicine registration, including category 1 and category 2 submissions lodged via the streamlined submission process.
|Therapeutic goods legislation amendments - fees|
|Therapeutic Goods Act 1989 - s.24D||When the Therapeutic Goods Amendment (2011 Measures No. 1) Bill 2011 receives the Royal Ascent||
Currently an applicant making an application under s. 23 of the Act for the registration of a prescription medicine is only required to pay 75% of the evaluation fee when the application is accepted for evaluation, with the remaining 25% payable only if the evaluation is completed within the statutory timeframes.
This rule is being changed to require full payment of the evaluation fee when the application is accepted for evaluation. If the decision on the application is not made within the statutory timeframe, 25% of the evaluation fee will be refunded.
|Therapeutic Goods Regulations 1990 - regulation 43AA||1 July 2011||The change to regulation 43AA has the same effect in relation to applications made under s. 9D(3) of the Act to which regulation 16D applies (i.e. category 1 or category 2 variations) as the change described above in relation to s.23 applications.|
|Therapeutic Goods Regulations 1990 - Schedule 9||1 July 2011||Amendments to set out appropriate application fees for some application types (as noted below) and increased fees for all application types for the 2011/2012 financial year.|
Key changes introduced by legislative amendments
Splitting of application and evaluation fees
A key change introduced by the regulations that came into effect on 1 July 2011 is the formalisation of a division of the evaluation fee into a separate application fee and evaluation fee. The TGA has not applied separate application and evaluation fees for applications made to the TGA since July 2003. Instead, these fees have been collected as one payment (the evaluation fee). The evaluation fees were set so that the level of the fee payable allowed the TGA to recover the cost of application processing as well as the evaluation. In the event the application was withdrawn or rejected prior to the commencement of evaluation, 20% of the evaluation fee (informally referred to as the ‘application fee’ and capped at $7,780) was payable to cover application processing costs.
As of 1 July 2011, application fees will be payable when the PPF is lodged, and evaluation fees adjusted accordingly. The amount of the application fee and evaluation fee under the new arrangement will be equivalent to the former evaluation fee (a 20/80 split), subject to the general increase in fees described below.
Payment of application fee
Upon lodgement of a pre-submission planning form, sponsors will become liable to pay the application fee. The application fee allows the TGA to recover the costs associated with processing the form and arranging evaluation resources. If a PPF is considered not complete and not acceptable or the submission dossier is not subsequently accepted for evaluation, the sponsor will forfeit this application fee. Sponsors should note that this amount is no longer capped at $7,780. If a sponsor has not paid the application fee before the submission dossier is lodged, the submission dossier will be considered not effective and not accepted for evaluation.
Payment of 100% of evaluation fee upfront
For PPFs lodged prior to 1 July 2011, sponsors become liable for a minimum of 75% of the evaluation fee at submission lodgement. If the evaluation is completed within the statutory timeframe, sponsors must pay the remaining 25%. Sponsors can elect to pay the full 100% at submission lodgement.
Under the new arrangement, the full evaluation fee is due and payable when the applicant is notified that the submission is accepted for evaluation. The notification letter will specify the evaluation fee amount payable. If the evaluation fee is not paid within two months from that date of the notification letter, the application will lapse (see s. 24(2) of the Therapeutic Goods Act). In this case, the sponsor will forfeit the application fee but will still be liable to pay the evaluation fee. Where a decision on the application is not made within the statutory timeframe, 25% of the evaluation fee will be refunded by the TGA to the sponsor.
Increase in fees
Following the TGA's annual review of fees and charges, fees will increase by 3.4% from 1 July 2011. This increase is a general composite increase calculated using a formula agreed between the TGA and industry associations. The increase is comprised of 50% of the Labour Price Index from September 2009 to September 2010, and 50% of the Consumer Price Index for the same period. The increases to fees have been rounded to the nearest $10 for amounts less than $10,000, and to the nearest $100 for amounts of $10,000 or more. Fees of $140 or less for items have not changed. For further information, see the Therapeutic Goods Amendment Regulations 2011 (No. 2) explanatory statement.
Fee arrangements for streamlined submission process
The table below provides an overview of the new fee arrangements under the streamlined submission process.
|Streamlined submission process fee arrangements|
|Phase/milestone||PPFs lodged until 30 June 2011||PPFs lodged from 1 July 2011|
|No fee payable at lodgement of the PPF||Sponsor is required to pay the application fee at lodgement of the PPF. If the fee is not paid at PPF lodgement, the TGA will invoice the sponsor.|
Outcome of pre-submission sent
|If the TGA considers the PPF not complete and not acceptable, there is no financial penalty.||If the TGA considers the PPF not complete and not acceptable, the sponsor forfeits the application fee.|
|Sponsor pays 75% of evaluation fee at submission lodgement.||Sponsor can choose to pay the evaluation fee at submission lodgement.|
Outcome of submission consideration sent
If the TGA considers the submission not effective and not accepted for evaluation, the sponsor is liable to pay 20% of evaluation fee up to a maximum of $7,780.
If the TGA considers the submission effective and it is accepted for evaluation and a decision on the application is made within the statutory timeframe, the sponsor must pay the remaining 25% of the evaluation fee.
If the application fee is not paid prior to submission lodgement, the submission will be considered not effective and will not be accepted for evaluation.
If the application fee has been paid but the TGA considers the submission not effective and not accepted for evaluation for some other reason, the sponsor forfeits the application fee.
If the TGA considers the submission effective and it is accepted for evaluation, the sponsor will be informed of the evaluation fee amount in the notification letter (if it has not already been paid).
If the evaluation fee is not paid within two months of the date of the notification letter, the application lapses in accordance with s. 24(2) of the Act.
If the sponsor has already paid the evaluation fee at submission lodgement but the submission is considered not effective and is not accepted for evaluation, the TGA will refund the evaluation fee.
If a decision on the evaluation is not made within the statutory timeframe, the TGA will refund of 25% of the evaluation fee.
Regulatory and supporting documents
TGA regulatory and supporting documents will be updated as required to reflect these changes.
Contact the BPR team
PO Box 100
Woden ACT 2602
- Telephone: 02 6232 8250
- Facsimile: 02 6232 8140
- Email: email@example.com
- Email: firstname.lastname@example.org (for current PPFs and submissions under streamlined process)
© Commonwealth of Australia 2011
This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights should be addressed to the Commonwealth Copyright Administration, Attorney General's Department, National Circuit, Barton ACT 2600 or posted at http://www.ag.gov.au/