Questions & answers about the streamlined submission process
24 January 2012
Sponsors will provide planning data at the pre-submission phase, in accordance with the requirements of the pre-submission Planning form (PPF). Sponsors must provide details of the quality, non-clinical and clinical evidence. This planning data will provide the TGA with the necessary level of understanding of the proposed submission to enable effective resource planning.
Sponsors should not lodge a PPF until they are confident that all necessary data for evaluation will be ready for delivery on the proposed submission date. Sponsors who do not submit on the submission date will need to resubmit the PPF and may forfeit the application fee.
|Clear and comprehensive TGA requirements||The TGA has produced clear and comprehensive guidance on what must be included in a submission for it to be validated as 'effective' and accepted for evaluation. Refer to Transitional mandatory requirements for effective submissions.|
Sponsors must lodge well-planned, high quality, complete submissions. Where sponsors submit incomplete, delayed or poor quality submissions the submission will be regarded as 'not-effective' and will not be accepted for evaluation. To facilitate the preparation of effective submissions by sponsors, the TGA has:
The TGA is also continuing work to:
|Management by milestones||The streamlined submission process consists of eight phases with eight milestones, allowing effective planning and tracking by the TGA and sponsors. Each phase has established time periods specified in the planning letter, which will be managed by the TGA to ensure timeframes are met and documentation is completed.|
|Submission||Sponsors provide data for evaluation at the submission phase. Sponsors must ensure submissions meet the TGA requirements for format and content or the submission will be validated as not effective. The previous 40 working day period for the screening of submissions on receipt has been replaced by a shorter period for ascertaining whether the submission will be treated as effective and therefore accepted for evaluation, or not-effective and rejected. For straightforward submissions, this process will generally be completed in a 15 calendar day period. Complex submissions (refer to 'How does the TGA define complex submissions for which evaluation cannot be completed within the 3 months allocated for the 1st round assessment phase?') may take longer but the process will be completed by the end of the month in which the submission is received.|
|Consolidated set of questions for sponsors||
There will no longer routinely be multiple requests for information under s. 31 of the Act. There will now be:
|No additional data or supplementary data||
The documentation presented at submission will be taken as the complete submission; there will be no further opportunity to deliver new data (including label mock-ups or specimens) after the submission date, with the following exceptions:
There will no longer be an opportunity for sponsors to provide supplementary data on receiving the evaluation reports.
Any new data to support labelling changes or extend shelf-life must be lodged as a separate submission post-approval.
|Establishment of the coordination team||The coordination team will be responsible for all administrative aspects of a submission from the time the PPF is received. Within this unit, a dedicated single contact point will be established for each submission. (See 'Who will I contact at the TGA with queries about my submission?' for more information.)|
The Transitional mandatory requirements for effective submissions, outlines the new streamlined processes and the regulatory requirements for sponsors. It is intended that the contents of this document will be incorporated into the Australian regulatory guidelines for prescription medicines (ARGPM) at the end of the 12 month transition period for the streamlined submission process.
The ARGPM remains on the TGA website as it contains information not yet reflected in the Transitional prescription medicine streamlined submission process document. Where there is conflicting information in the two documents, the Transitional prescription medicine streamlined submission process document should take precedence.
These documents are complemented by a transitional CTD Module 1 - Administrative information and prescribing information, which has been updated to reflect the requirements of the streamlined submission process. Several versions of this document are available on the website:
|CTD Module 1 version||Changes||Applies to|
|November 2008||Not applicable||All submissions received at the TGA up to, and including, 28 October 2010|
|September 2010||Updated to reflect the requirements of the streamlined submission process||All submissions received at the TGA from 29 October 2010 to 28 February 2011(inclusive)|
|January 2011||Corrections and clarifications||All submissions received at the TGA from 1 March 2011 onwards|
Both the September 2010 and January 2011 versions of the CTD Module 1 have been released as transitional documents on the basis that further refinements may be required to support the objectives of the streamlined submission process. The TGA therefore welcomes all feedback to support further improvements and comments should be emailed to the Case management team
The November 2008 version of CTD Module 1 will remain on the TGA website for the interim as it contains forms that have not yet been published separately that are required for submission dossiers (eg drug master file details form).
Many aspects of the streamlined submission process can be implemented without legislative changes. However the TGA identified a number of areas where the legislation needed to be clarified. A number of minor amendments are contained in the Therapeutic Goods Amendment (2010 Measures No. 1) Act 2010 which received the Royal Assent on 15 December 2010. The relevant amendments are described in the Explanatory Memorandum tabled in the Senate in relation to the amending legislation. The 12 month transition period will assist both the TGA and sponsors to work towards the new requirements and 'iron out' the regulatory processes.
Two new legislative instruments have been activated. These instruments represent the Secretary's approved specification for the "form" required for applications under s. 23 of the Act and define the regulatory requirements with which submissions must comply. Refer to "How will I know what needs to be in my submission?" for more information.
The TGA has commenced planning and implementing a range of supporting tools to assist sponsors preparing submissions and to address all relevant requirements under the new regulatory processes. These tools are explained further in the table below.
The eBS portal used for the initial pilot of the pre-submission planning form will be further enhanced to assist sponsors in meeting their pre-submission requirements. The upload file size limit has now been removed and further enhancements are under consideration. (See also pre-submission planning form below.)
Longer term, the TGA will expand on the existing electronic lodgement facility for new chemical entities and new generic submissions to include functionality for variations (major variations, PI changes, category 3 submissions etc).
|Pre-submission planning form (PPF)||
Further enhancements will be made to the PDF version of the pre-submission planning form to make completion requirements clearer for sponsors. A document Information for sponsors completing the pre-submission planning form has also been published; it includes examples of how to complete the PDF form in more complex scenarios.
Longer term, the TGA will implement an online smart form to replaced the PDF form. The online form will provide additional functionality and assistance for users, including a context sensitive help facility.
|Regulatory requirements documents||The revised CTD Module 1, the pre-submission planning form and the current application forms have been released. (See 'How will I know what needs to be in my submission?' for more information.)|
|Single contact point||On processing a PPF, the TGA will allocate a dedicated resource to manage the submission through to completion of the regulatory process. This contact point will be the main contact for sponsors seeking assistance with, or information about, their submission. (See 'Who will I contact at the TGA with queries about my pre-submission or submission?' for more information.)|
|Milestone dates table||The TGA has prepared a table that indicates the target timeframes for each milestone, based on the date that a PPF is received. (See 'How will I know the milestone dates?' and 'Can milestone dates be varied?' for more information.)|
|TGA planning letter||Within six weeks of the TGA processing a PPF, the TGA will send the sponsor a TGA planning letter. This letter will specify regulatory processes and key milestone dates for sponsors. (See 'What is a TGA planning letter and when will I receive it?' for more information.)|
The streamlined submission process involves dedicated TGA resources being allocated to manage each submission. For any queries that you have from the time you lodge your PPF, there will be a single contact point to manage all aspects of your submission until it is finalised. The single contact point will be identified in the TGA planning letter. Prior to receiving the TGA planning letter, queries relating to specific pre-submission planning forms should be directed to email@example.com.
A 12 month transition period will:
- allow sufficient time for preparation and release of the requirements for the streamlined submission process
- acknowledge concerns raised by respondents to the TGA consultation processes that the streamlined submission process is a significant change in business practices for both sponsors and the TGA.
During this period the TGA will be processing PPFs, preparing TGA planning letters and scheduling evaluators to commence evaluating submissions from 1 February 2011. The TGA will also focus on completing as many of the evaluations on hand as possible in this period.
No. Submissions that are ONLY for ATNs will continue with the current processes, in the same way that there will not be any changes to the processes for category 3 submissions. Sponsors are not required to lodge a PPF for an ATN submission and the current statutory and target timeframes will continue to apply.
You must write to the TGA justifying the particular combination and the type and extent of data to be submitted. The justification must be lodged with the TGA for consideration well in advance of the lodgement of a PPF. The justification can be discussed at a pre-submission meeting if necessary.
The justification should focus on the issues outlined in part 4 of the Guideline on fixed combination medicinal products (CPMP/EWP/240/95). If, after a review by the TGA, you are advised in writing that the fixed dose combination is acceptable for review, the PPF can be lodged.
Where the TGA considers that the fixed dose combination is not acceptable for review, the PPF cannot be lodged. The sponsor will be advised of the reasons in writing, which may be used by the sponsor to seek further discussion and consideration via the Advisory Committee on Prescription Medicines.
More information is available from the Australian regulatory guidelines for prescription medicines (ARGPM).
No. However, the trade name(s) must be finalised before lodging the submission so that appropriate labels, product information documents and consumer medicine information documents can be included in the submission dossier.
Where a trade name has not yet been confirmed or finalised, this should be indicated in the PPF in the 'other information' field on page 11.
The TGA requires sponsors to include proposed trade names in their submission dossiers, and if available at the time, on the pre-submission planning form.
The TGA recognises there is value in providing sponsors with advice on proposed trade names prior to lodgement of the PPF and this was proposed by the TGA in the streamlined submission process training sessions. However, a review of trade name assessment has confirmed it is not currently feasible for the TGA to implement a full advisory and approval process prior to PPF or submission lodgement.
As such, PPFs can be lodged without advice from the TGA on the trade name(s) proposed. The TGA strongly advises that prior to lodging a PPF or submission dossier, sponsors:
- perform a search on the public ARTG view to confirm the proposed trade name is not already registered
- perform a search on the public ARTG view to confirm the proposed trade name is not similar to a trade name(s) already registered, for example, to ensure it does not look-like or sound-like an existing trade name
- assess the proposed trade name against section 12 of the Best practice guideline on prescription medicine labelling, section 1.5.4 of CTD Module 1 January 2011, and other relevant guidelines
- prepare at least one alternative name for each product should the TGA evaluation identify issues with the proposed trade name(s).
This procedure is recommended for all proposed trade names, irrespective of whether they have been approved elsewhere in the world.
The TGA advises that this procedure will provide sponsors with a level of confidence, but will not guarantee the acceptance of the proposed trade name. The TGA can only evaluate the proposed trade name during the assessment phases.
The streamlined submission process will apply to submissions to register a new prescription medicine, or changes to an already registered medicine that involve clinical, non-clinical or bioequivalence data. For these submissions, a pre-submission planning form must be lodged a minimum of 2 1/2 months prior to the date the submission is to be lodged.
|Type of submission||Pre-submission planning form required?|
Category 1, including:
|Category 1 - only involving additional trade name/s||No|
|Category 2 - applications supported by previous approvals and independent evaluation reports, from two acceptable countries||Yes|
|Category 3 - applications involving changes to the quality data of medicines already included on the ARTG which, in the opinion of the TGA, do not need to be supported by clinical, non-clinical or bioequivalence data.||No|
Pre-submission planning forms are mandatory from 1 November 2010 for submissions requiring a pre-submission planning form. (See 'Which submissions will require a pre-submission planning form?')
You will need to have completed a pre-submission planning form and lodged it with the TGA before 1 November 2010. You will receive a TGA planning letter which will identify the date by which you will need to lodge your submission. The TGA will commence evaluating your submission on 1 February 2011.
Initially the lodgement of the pre-submission planning form (PPF) will be a two-step process:
- electronically complete the PPF available on the TGA website
- submit the PPF and the associated supporting data using the pre-submission facility in the TGA's eBS online services website.
The pre-submission planning form must be lodged via eBS. The Form should not be sent via post, email, fax etc. A printout of the eBS lodgement details should be provided with the submission when it is lodged. (Refer to the transitional CTD Module 1 document for more information.)
This process is an interim arrangement and the TGA is working towards the PPF being integrated into eBS.
Within six weeks of the TGA processing a PPF, the TGA will send the sponsor a TGA planning letter that provides the expected submission date (based on the sponsor's proposed date), the single contact point, and the target dates for key milestones, such as the release of the consolidated set of s. 31 questions.
The TGA will determine if sufficient scientific justification is provided for not meeting a particular standard and/or guideline. It is expected that a robust scientific justification will:
- clearly identify the standard/guideline or part of the standard/guideline that is not being met
- specifically address why the standard/guideline is not being met
- have a contemporary scientific basis
- include citations to the relevant reference documents, including TGA documents where appropriate.
The PPF will be considered incomplete if:
- the PPF is not fully completed
- the necessary information (module 2 or equivalent) is not provided as attachments to allow the scope of the submission to be assessed
- the wrong application type is selected.
If deficiencies identified by the TGA cannot be rectified within two working days, then the PPF will be considered incomplete and the sponsor will be formally advised that the TGA cannot progress planning for the submission due to the unresolved deficiencies. The sponsor will need to re-lodge a PPF once they are able to rectify the deficiencies.
|If there are...||then the TGA will...|
|defects in the PPF or data provided with the PPF||
|deficiencies identified in the proposed data supporting the submission||advise details of the deficiencies in the TGA planning letter. Such deficiencies may need to be rectified by the sponsor before lodging the submission, otherwise the submission may be validated as not effective.|
Yes. A sponsor may reduce the scope of the submission. However, they cannot increase the scope of a submission because the TGA will use the information provided in the PPF to plan the evaluation of the submission.
For example, if a PPF identifies four proposed indications for registration and the sponsor decides that they do not wish to proceed with one of the indications, this is acceptable. If a sponsor decides that they want to add a new indication, this is not acceptable.
An 'equivalent' document is one that:
- may be in either draft or final version (see below)
- contains all of the information specified in the relevant subsection of module 2
- does not need to be in the format or structure specified by the relevant subsection of module 2.
The TGA considers a 'draft' version of a document is a document that has been through the sponsor's standard scientific quality assurance checks but has not yet been checked for administrative quality.
For example, a sponsor's internal document used for the initial consideration of the viability of a new chemical entity product that provides all of the information required by subsections 2.3.S, 2.3.P, 2.4, 2.6.2, 2.6.4, 2.6.6, 2.5, 2.7.1, 2.7.2, 2.7.3 and 2.7.4 but is presented in a different structure would be acceptable for attachment to the PPF.
A PPF will not be acceptable if it is not complete. It will be considered to be incomplete if it does not contain all the material that the TGA requires to be provided. These requirements are set out and described in Information for sponsors completing the pre-submission planning form.
It should be noted that you will be given an opportunity to rectify the issues with the PPF before it is considered incomplete and regarded as not acceptable. See 'When will a PPF be considered incomplete?' for more information.
You will be contacted and advised that a pre-submission planning form (PPF) is required for your submission to proceed. Your PPF and submission will then be subject to the streamlined submission process and associated timeframes - there will be no opportunity to expedite the PPF or the submission. In addition, you will be required to re-lodge module 1 of the submission dossier with updated documents. You may need to resubmit a complete submission dossier if the TGA identifies any issues with the submission while processing the PPF.
The format of your submission is prescribed by the legislative instruments entitled 'Approval of form for application for registration of therapeutic goods under section 23 of the Therapeutic Goods Act 1989': s.23(01): Approval of form for application for registration of therapeutic goods under Section 23 and s.23(02): Approval of form for application for registration of therapeutic goods. These instruments require that submissions conform to common technical document (CTD) format, including the transitional CTD Module 1 document. (See 'When will the requirements of the streamlined submission process be released?' for more information.)
The contents of the submission dossier are determined from the applicable CTD documents, Australian guidelines, and EU guidelines adopted in Australia. Information regarding processes and pre-conditions to submission lodgement are available in:
- the Australian regulatory guidelines for prescription medicines (ARGPM)
- the Transitional mandatory requirements for effective submissions document.
Note that the latter document takes precedence where the ARGPM conflicts.
The TGA planning letter will tell sponsors the date by which the submission must be lodged. The submission can be lodged anytime between the receipt of the TGA planning letter and the required date for lodgement identified in the letter. However, submissions will not be processed until the lodgement date.
If submissions are not lodged by the lodgement date specified in the planning letter, the TGA will reassign the resources which had been allocated to evaluate the submission. Sponsors will need to resubmit a PPF. This will delay the evaluation process.
The TGA will determine if your submission is effective or not effective. Sponsors must:
- meet the requirements of the streamlined submission process, including providing all the necessary supporting data
- provide a comprehensive, high quality dossier that meets the requirements set out in the Transitional mandatory requirements for effective submissions
- pay the appropriate evaluation fee.
The TGA will issue a letter to advise whether the submission is considered effective or not effective. In the case of the latter, the letter will also advise as to why the submission was considered not effective. If it is not effective it will not be accepted for evaluation.
The TGA will contact you. The TGA has developed regulatory requirements to clearly identify where sponsors will be able to rectify minor deficiencies - this will generally be where data has been omitted as an oversight and can be forwarded to the TGA within two working days thereby avoiding delay to the commencement of the evaluation process which is critical to achieving the milestone dates for the preparation of the consolidated s. 31 questions.
You will be advised by letter that your submission is not effective. Once you have rectified the deficiencies in your submission you can lodge the PPF again and then lodge the submission 2 1/2 months later.
This depends on the reason for which the submission regarded as not effective.
|Reason regarded as not effective||Submission dossier can be reused?||Comments|
|Submission dossier provided but not by required date||Yes||The TGA will consider the dossier previously provided.|
|Any other reason||No - a new dossier will have to be provided||The sponsor retains responsibility for providing the TGA with the data that meets all relevant requirements in order for it to be evaluated.|
If an existing submission dossier is to be reused, this must be identified in the PPF. Further, the appropriate number of copies of a revised and complete module 1, containing fresh application forms etc, must be provided at submission lodgement.
The deficiencies must be of a minor nature and easily rectified. The following criteria must be met:
- replacement/inadvertently omitted documentation must be provided in hard copy and electronically within two working days
- less than seven volumes require updating - each copy of a volume is counted as one volume
- hard copies of the entire volume must be provided again, including the appropriate number of copies
- the electronic copy of the entire submission must be provided again.
- Contact the sponsor, advise of the issue and the two working day timeframe to lodge the submission in eBS and provide a hardcopy of the relevant volume of module 1 plus the additional copies required.
- On receipt of paperwork, the TGA will:
- annotate the existing form as 'Replaced dd/mm/yyyy' and insert new forms
- transfer the applications and invoice from the electronic lodgement submission ID to the original submission ID.
- If the sponsor cannot lodge the submission electronically and provide the paper copies to the TGA within the timeframe then the submission will be validated as not effective and the application fee forfeited.
The appropriate action depends on the type and extent of the differences.
|Type of difference||Action|
|Corrections to spelling, grammar, relocation of text within a submission document, minor typographical errors that do not impact on the scope or scale of the submission||No action required|
|Changes to documents arising from TGA feedback in the planning letter||Changes should be summarised in module 1.8.3 of the submission|
|Other changes that impact on the scope/scale of the submission||Contact the TGA single contact point for discussion and advice|
A submission will not be accepted if it does not comply with all the requirements as set out in Transitional mandatory requirements for effective submissions, and/or it has not been prepared in accordance with any requirements of the Secretary under subsections 23(1) or (2) or subsection 9D(6) of the Therapeutic Goods Act. In such a case the submission will be taken to be 'not effective' and will not be evaluated by the TGA.
It should be noted that before a submission is taken to be not effective (and therefore not accepted for evaluation), the TGA will where ever possible give the sponsor an opportunity to rectify the issues with the submission.
One of the key components of the streamlined submission process is the consolidated s. 31 questions. Currently, sponsors can receive multiple sets of questions under s. 31 of the Therapeutic Goods Act 1989 from different areas of the TGA throughout the evaluation process. The streamlined submission process will provide for a single set of evaluation questions from all the evaluation areas of the TGA. The consolidated s. 31 questions will be provided by the TGA at the end of the 1st round assessment phase. The consolidated s. 31 questions will be sent at the date pre-designated in the planning letter allowing sponsors to conduct any necessary preparation activities.
The TGA will ensure that the questions asked are relevant to the evaluation of the quality, safety and/or efficacy of a medicine and that appropriate context is given to sponsors to enable them to understand the issue that has been identified.
Sponsors are required to nominate a 30 or 60 (calendar) day response period in the PPF. This will be the response period used by the TGA if the submission is accepted for evaluation.
It is not possible for the TGA to determine at the time the milestone dates for the submission are proposed during the pre-submission phase whether a s. 31 request for information or documents will be needed or to estimate how many questions might be contained in such a request. It will be necessary therefore for the TGA to set the milestone dates and plan the allocation of evaluation resources on the assumption that there will be a s. 31 request for documents/information requiring a response from the sponsor. The timeline will remain as set out in the planning letter irrespective of whether a s.31 request is in fact made.
Sponsors should therefore expect that the TGA will meet the milestone dates provided in the TGA planning letter even if there is no s. 31 request unless the TGA contacts the sponsor to negotiate revised timeframes.
You should contact the TGA officer who signed the s. 31 request as soon as possible.
It should be noted that a failure to lodge a s. 31 response or failure to lodge a complete s. 31 response will not necessarily result in a rejection of the submission or termination of the evaluation. Evaluation of the submission will continue on its merits and where appropriate, may be approved with reduced scope and/or additional conditions of registration. Discussion of the issues with the TGA will allow sponsors to make an informed decision in such situations.
No. In order to provide predictable timeframes and allow the TGA to effectively plan evaluation resources, neither additional data or supplementary data can be accepted. The following exceptions do apply:
- data that applies to new safety signals (sponsors are obligated to inform the TGA as soon as new information becomes available)
- the TGA requests specific data as part of the evaluation process.
A key component of the streamlined submission process is the identification 2 1/2 months in advance of submission lodgement of the extent of supporting data for evaluation. This allows the TGA to effectively allocate resources for the evaluation process. The 12 month transition period will assist in management of this new process.
The TGA will work with sponsors of critical medicines to ensure that this policy does not adversely affect the timely evaluation (and where appropriate, subsequent approval) of the medicine. Sponsors of such medicines are encouraged to discuss such medicines with the TGA at a pre-submission meeting as early as possible.
The TGA contact point for your submission will contact you to negotiate revised timeframes.
The TGA has prepared a table that provides indicative timeframes for the milestones during the 12 month transition period. These dates are based on the date that a PPF is received.
|Pre-submission received by||Outcome of pre-submission planning sent||Submission lodged with TGA by||Outcome of submission validation sent||Evaluation starts||Outcome of 1st round assessment sent||End of s. 31 response period - 30 day||End of s. 31 response period - 60 day|
|1 Nov 10||15 Dec 10||15 Jan 11||31 Jan 11||1 Feb 11||1 Jun 11||30 Jun 11||31 Jul 11|
|1 Dec 10||15 Jan 11||15 Feb 11||28 Feb 11||1 Mar 11||1 Jul 11||31 Jul 11||31 Aug 11|
|1 Jan 11||15 Feb 11||15 Mar 11||31 Mar 11||1 Apr 11||1 Aug 11||31 Aug 11||30 Sep 11|
|1 Feb 11||15 Mar 11||15 Apr 11||30 Apr 11||1 May 11||1 Sep 11||30 Sep 11||31 Oct 11|
|1 Mar 11||15 Apr 11||15 May 11||31 May 11||1 Jun 11||1 Oct 11||31 Oct 11||30 Nov 11|
|1 Apr 11||15 May 11||15 Jun 11||30 Jun 11||1 Jul 11||1 Nov 11||30 Nov 11||31 Dec 11|
|1 May 11||15 Jun 11||15 Jul 11||31 Jul 11||1 Aug 11||1 Dec 11||31 Dec 11||31 Jan 12|
|1 Jun 11||15 Jul 11||15 Aug 11||31 Aug 11||1 Sep 11||1 Jan 12||31 Jan 12||29 Feb 12|
|1 Jul 11||15 Aug 11||15 Sep 11||30 Sep 11||1 Oct 11||1 Feb 12||29 Feb 12||31 Mar 12|
|1 Aug 11||15 Sep 11||15 Oct 11||31 Oct 11||1 Nov 11||1 Mar 12||31 Mar 12||30 Apr 12|
|1 Sep 11||15 Oct 11||15 Nov 11||30 Nov 11||1 Dec 11||1 Apr 12||30 Apr 12||31 May 12|
|1 Oct 11||15 Nov 11*||15 Dec 11*||31 Dec 11*||1 Jan 12*||1 May 12*||31 May 12*||30 Jun 12*|
*these dates are to be confirmed
Under the streamlined submission process, milestone dates are indicative only. There are many scenarios that impact on the final milestone dates that the TGA provides in the planning letter for a particular submission. The planning letter indicates the TGA has considered the information provided in the PPF, planned the evaluation and committed to milestone dates. In the planning letter the TGA is required to explain any variation to the default milestone dates as set out in the table above. If any variation to the milestone dates is required, the TGA will discuss this with the sponsor prior to sending the planning letter.
A PPF must be lodged no more than 6 months but not less than 2 1/2 months in advance of the submission being lodged. For example, if a sponsor intends to lodge a submission on 15 June 2011, the PPF cannot be lodged before 15 December 2010 but it must be lodged before 1 April 2011.
Yes. However, sponsors will no longer need to apply for priority evaluation status. The TGA will identify when it is genuinely in the public interest for a critical medicine to be made available as soon as possible. The requirements for priority evaluations/rolling submissions will be included in the documents for the streamlined submission process.
No. Sponsors should not assume that a submission that will result in a new entry on the ARTG will be approved. If the proposed submission is dependent upon the approval of the earlier submission, the earlier submission must be approved and the product entered on the ARTG prior to any further PPF being accepted. This is to avoid any wasted TGA resources and financial loss for the sponsor if the approval of the earlier submission is unexpectedly delayed or is not approved. This also applies to new products resulting from container and/or formulation changes processed as category 3 applications.
A PPF for a fixed dose combination product cannot be lodged until the TGA delegate has approved a request from the sponsor to lodge a submission for a fixed dose combination product.
If the fixed dose combination product contains an NCE that is not currently on the ARTG, then the sponsor may:
- wait until the NCE is on the ARTG to lodge the PPF for the fixed combination product
- lodge the PPF and the subsequent submission/s for the new NCE and fixed dose combination product simultaneously, ensuring that the TGA is aware of the links between the products.
The PPF may be lodged prior to the data protection period expiring. However, the submission cannot be lodged until the 5 year data protection period has expired.
Where data protection provisions apply to a medicine but the sponsor has data to support the submission that is not covered by the protection provisions, a PPF and subsequent submission can be lodged as if it was an NCE.
Until the eCTD is introduced, the TGA's requirements are as follows:
|Lodging a PPF|
|Responses to consolidated s. 31 questions|
The number of copies required of each document are specified in the transitional CTD Module 1.
The electronic copy of the dossier may be prepared in non-eCTD electronic submission format or in eCTD format. Further information is available on the TGA website.
Until the implementation of the eCTD, large submissions may need to be lodged earlier to allow additional time for administrative processing to occur before the commencement of the evaluation. These submissions will generally be submissions that include in excess of 300 volumes for modules 4 and 5 combined. This process will be monitored during the transition period.
Submissions that are complex and may require more than 3 months evaluation include submissions for products that:
- include more than one indication and/or dosage form
- are literature based submissions or hybrid literature based submissions
- modified release products
- biological medicines
- refer to more than five drug master files
- are products proposed for re-scheduling
- have novel pharmacology.
This depends on the types of submissions and applications involved and whether or not there is a dependency between the existing and proposed submissions. Contact the TGA contact point for the submission currently under evaluation for advice.
No, this would be considered additional data and therefore will not be accepted. Sponsors may, however:
- lodge a category 3 application immediately on registration of the product to extend the shelf life
- provide a stability protocol in the module 2 attachments to the PPF that will support the generation/compilation of stability data during the period between PPF lodgement and submission lodgement.
On 1 July 2011, legislative changes in relation to fees payable to the TGA came into effect. Under the changes, the evaluation fee has been divided into an application fee and an evaluation fee. As of 1 July 2011, an application fee will be payable when the PPF is lodged, and the evaluation fee 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 annual increase in fees.
If a sponsor has not paid the application fee before lodging the submission dossier, the submission will be considered not effective and not accepted for evaluation.
Further details on the fee changes and the implications for applications lodged under the streamlined submission process are reported in the July 2011 edition of the BPR update newsletter. TGA fee information can be found under the fees & payments section of the TGA website.
If the TGA considers a PPF not complete and not acceptable, the sponsor will forfeit the application fee.
The full evaluation fee is due and payable when the applicant is notified that the submission is considered effective and accepted for evaluation. The notification letter will specify the evaluation fee amount payable. If the evaluation fee is not paid within two months from the 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 and 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.
If a submission is considered not effective and not accepted for evaluation, the sponsor will forfeit the application fee.
The application and evaluation fees do not apply to submissions to register an orphan drug designated medicine, provided that designation has been granted prior to lodgement of the PPF.
The full evaluation fee is due and payable when the sponsor is notified that the TGA considers the submission effective and accepted for evaluation. If the submission is withdrawn after this point, the sponsor remains liable for the full evaluation fee.
The eCTD project and the streamlined submission process are managed as separate projects. The TGA does not plan to introduce both reforms at the same time due to the complexity of the changes for each project.
The ACPM has published its 2011 meeting schedule on the TGA website.
In anticipation of the TGA's new regulatory process requirements, the ACPM has provisionally allocated additional two-day meetings from July 2011 to enable the TGA to request monthly meetings, should this be required. The ACPM has agreed to confirm activation and publish these additional meeting dates at their May 2011 meeting.
Content last updated: Tuesday, 24 January 2012
Content last reviewed: Tuesday, 24 January 2012
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