Questions & answers about the streamlined submission process

Activity	Description
Pre-submission	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.
Submission quality	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: provided clear guidance on what must be included in an effective submission conducted training/workshops for sponsors on the requirements for an effective submission worked with industry representatives to seek input on complex requirements. The TGA is also continuing work to: improve the documents providing guidance on the requirements for an effective submission develop intuitive IT systems with smart form technology ensure appropriate legislative underpinning and disincentives (eg financial, timeframes) for sub-standard submissions.
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: a list of consolidated s. 31 questions prepared by the TGA at the completion of the 1st round assessment phase. These questions will be sent at the pre-designated date specified in the planning letter so sponsors may conduct any necessary preparation activities where applicable, this will be followed by an opportunity to provide comment (pre-committee response) on the delegate's overview prior to independent review of the evaluation by the Advisory Committee on Prescription Medicines (ACPM).
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: data 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. 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.

Tool	Comments
eBS	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.)

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.

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: new chemical entities new biological entities similar biological medicinal products new combination products extension of indications major variations new generics changes to product information requiring evaluation of data minor variations	Yes
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

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.

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	call the sponsor to advise of the deficiencies and ask how easily they can be rectified - if the data deficiencies cannot be rectified within two working days then the PPF will be considered incomplete confirm issues and arrangements for correction in writing
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.

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 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.

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.

What TGA identified deficiencies can I correct after a submission has been lodged?

I have provided a paper application form for an NCE or new generic submission, where electronic lodgement via eBS is now mandatory. What will the TGA do?

There are some differences between the information provided in my PPF and the submission. What do I do? New 1/1/11

The TGA has advised me that my submission will not be accepted. What can I do? New 1/1/11

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Consolidated section 31 questions

What are the consolidated s. 31 questions?

How long will I have to respond to the consolidated list of questions?

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.

What happens to my submission if there is no need to make a s 31 request for information or documents?

What do I do if I cannot answer some/all of the s. 31 questions asked? New 1/1/11

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Additional data

Can I provide additional data and/or supplementary data? Updated 1/1/11

What happens if the TGA fails to meet a target date?

The TGA contact point for your submission will contact you to negotiate revised timeframes.

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Milestone dates

How will I know the milestone dates?

Can these milestone dates be varied?

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.

How far in advance of lodging a submission can the pre-submission planning form (PPF) be lodged?

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.

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Special cases

Will there still be priority evaluations/rolling submissions?

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.

Can I lodge a PPF to vary a product before it is on the ARTG? Updated 1/1/11

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.

When can a PPF be lodged for a fixed dose combination product?

When can a PPF be lodged where the 5 year data protection provisions apply?

When does the TGA require hard copy and electronic copies of documents?

How should an electronic copy of the submission dossier be constructed?

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.

How does the TGA define large submissions that must be lodged earlier than 15 days before the expected commencement of evaluation?

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.

How does the TGA define complex submissions for which evaluation cannot be completed within the 3 months allocated for the 1st round assessment phase?

Can I lodge a PPF to vary a product already on the ARTG while there is a submission currently under evaluation in relation to the product? New 1/1/11

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.

Can I lodge more stability data in support of my submission once the submission has been lodged? New 1/1/11

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Fees

Do I need to pay a fee when lodging a pre-submission planning form?

What happens to the application fee if my PPF is considered not complete?

If the TGA considers a PPF not complete and not acceptable, the sponsor will forfeit the application fee.

When do I need to pay the evaluation 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.

What happens if my submission is considered not effective and not accepted for evaluation?

If a submission is considered not effective and not accepted for evaluation, the sponsor will forfeit the application fee.

Do the application and evaluation fees apply to submissions to register an orphan drug designated medicine?

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.

Is the evaluation fee payable if I withdraw my submission after it has been accepted for evaluation?

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.

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Miscellaneous

What impact will the eCTD project have?

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.

How often will the Advisory Committee on Prescription Medicines (ACPM) be meeting in 2011?

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