TGA prescription medicines SSP newsletter, June 2012

Introduction

The TGA Prescription Medicines Streamlined Submissions Process Newsletter [formerly the Prescription medicine BPR update (BPR update)] reports on progress of the streamlined submission process.

In this edition:

• Impact of high application volume on TGA timelines
• Streamlined submission process
• Risk management plans
• Fee arrangements
• Expert Advisory Committee process reform
• Allocation of submissions to ACPM meetings

1 - Impact of high application volume on TGA timelines

The first half of 2012 has seen a higher than usual number of applications submitted to the TGA. As an example, in January, April and June the TGA received 40 or more presubmission planning forms (PPFs). This consistently higher than usual volume of applications is stretching TGA resources and we anticipate that this will impact on application processing timelines. The TGA will continue to inform sponsors of any changes to milestone dates in the streamlined submission process letters.

2 - Streamlined submission process

2.1 Summary of progress to date

The following is a summary of key statistics from applications lodged under the streamlined submission process since the end of the transition period. Due to the expansion and complexity of the summary statistics table, TGA will provide future progress to date of the streamlined submission process in a graph format only.

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2.2 Workflow analysis

The following is a summary of the number of calendar days taken to process specific types of applications from lodgement to decision of a submission. The data compares the quarterly average duration before and after the introduction of the streamlined submission process.

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2.3 Pre-submission planning form - common issues

The following information draws on common issues identified with pre-submission planning forms (PPF) lodged to date under the streamlined submission process. This information applies to all applications lodged under the streamlined submission process.

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2.4 Streamlined submission process – first review

The TGA is currently conducting a review of the performance of the streamlined submission process with a view to introduce process improvements to address issues identified during the first 18 months of operation of the new process. The initial stages of the review will focus on milestones 5 to 8. The TGA has engaged with the Industry Working Group on the proposed refinements, and a very productive meeting of this group was held on 29 May 2012. The TGA is now following up on those discussions and developing process improvement options.

2.5 Meeting milestones

The streamlined submission process is based on a series of key dates and milestones, some of which involve the TGA providing certain information to sponsors, such as the planning letter at milestone 1 or the notification letter at milestone 2.

From May 2011 to December 2011, the TGA was not able to consistently meet the milestone dates associated with milestones 1 - 3. A number of reasons can be provided, such as

• resource challenges posed by the double-processing of applications under the previous process and the streamlined submission process,
• insufficient evaluation resources available to assess submissions; and
• additional workloads associated with the 48 hour 'grace period' that applied during the 12 month transition period.

The TGA has been taking action to address this issue, including procuring additional external evaluation resources to assist with clearing the backlog and assessing procedural options to improve our ability to meet these milestones. A key strategy has been to establish the case management function, which was implemented in December 2011. The TGA announced this development in the December 2011 BPR Update.

These actions are having an impact. 84% of the planning letters for the combined December 2011/January 2012 batch were provided to sponsors within 3 days of the milestone 1 date. Given that this relates to 68 applications received in this batch and covers the TGA shutdown period and summer vacations for staff, this is an impressive achievement.

It can now be reported that from the February batch onwards, the TGA its meeting the milestone dates of the SSP in the majority of cases. Exceptions to this are when there are regulatory complex issues associated with a particular active ingredient or the PPF and supporting documentation or the submission dossier provided by the sponsor has been of poor quality requiring additional resources to identify and document the deficiencies.

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2.6 Milestone dates

The TGA has received feedback via the IWG that sponsors require more clarity around the way that milestone dates are calculated in the SSP. The table below describes the standard business rules that are applied to submissions that are complete and of sufficient quality to facilitate their processing. It must be noted that for submissions that are complete but that suffer from data quality issues, the milestone dates will be adjusted to reflect the additional effort required by TGA evaluators and delegates. Sponsors are notified of these milestone dates that apply to their application via the planning and notification letters.

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3 - Risk management plans

To improve accessibility to information within the SSP the TGA is undertaking a pilot to provide final Risk Management Plan (RMP) evaluation reports at milestone 3.

The TGA will begin to progressively provide final RMP evaluation reports at milestone 3 with the consolidated section 31 request. This is a pilot exercise aimed at improving access to information. The standard RMP S31 question accompanying final RMP evaluation reports at milestone 3 will be as follows: "Please provide information that is relevant and necessary to address the recommendations made in the RMP evaluation report."

Sponsors should continue to be aware that safety considerations may be raised by the nonclinical and clinical evaluators through:

• the consolidated section 31 request; and/or
• the nonclinical and clinical evaluation reports respectively (when these reports are made available).

It is important to ensure that the information provided in response to these include a consideration of the relevance for the RMP, and any specific information needed to address this issue in the RMP. For any safety considerations so raised, please provide information that is relevant and necessary to address the issue in the RMP.

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4 - Fee arrangements

4.1 Online invoice generation for application fee payments through the streamlined submission process

Applicants are advised that the electronic Business Services (eBS) portal has been enhanced to automatically generate an invoice for an application fee after lodgement of a PPF.

As detailed in the July 2011 BPR Update, new fee arrangements for submissions lodged under the streamlined submission process commenced in July 2011. The new fee arrangements resulted from amendments to the Therapeutic Good Regulations 1990. Due to the changes in the legislation, there was a need to develop and implement enhancements to the TGA's eBS. These changes are complete and applicants can now generate electronic invoices for application fees upon lodgement of their PPF.

4.2 Transition to electronic invoicing of application fee

The TGA reminds applicants that an application fee is due and payable upon lodgement of the PPF. Please refer to the Summary of fees and charges to determine the relevant application fee for the application submitted. Paragraph 23(2)(a) of the Therapeutic Goods Act 1989 (the Act) states than an application is not effective unless the application fee has been paid.

Applicants should continue to submit their payment directly to the TGA finance area using one of the prescribed payment methods and quoting the invoice number (e.g. ONLxxxxxx).

4.3 Payment of the evaluation fee

When the TGA accepts an application for evaluation, the applicant will be sent a notification letter as confirmation. The notification letter will specify the type of evaluation and the evaluation fee. Under section 24A of the Act, the evaluation fee is due and payable on the day the applicant is notified of the amount of the evaluation fee.

Under paragraph 24(2)(a) of the Act, an application lapses two months after the day on which the evaluation fee became due and payable (i.e., when the applicant was notified of the fee). The Act does not contain any provisions to grant extensions to applicants that fail to pay within this time. Payments can be made directly to the TGA finance area using one of the prescribed payment methods quoting the submission number (e.g. PM-2012-xxxxx-x) and Client I.D. or, upon being invoiced by the TGA.

4.4 Identification of the application to which the payment relates

It is the responsibility of the applicant to correctly identify the application to which the payment relates including payments made via EFTPOS. Identification of the application can occur through reference of the submission number (e.g. PM-xxxx-xxxx-x) or the invoice number (INV xxxxx, ONLxxxxxx).

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5 - Expert advisory committees

5.1 Implementation of Streamlined Submission Process changes

The ACPM meeting agendas now comprise almost entirely of SSP applications. The SSP business rules therefore apply to the relevant processes. This includes the timeline for the delivery of the ACPM outcomes. Work is currently underway to implement changes for alignment of the Pharmaceutical Subcommittee (PSC).

In addition, the TGA has taken the opportunity to streamline the outcomes notification process with the aim of delivering the full set of ACPM outcomes (extracted recommendation + minute) by the agreed milestone end date. This change adds significant value for sponsors as it modifies the previous process which involved the TGA delivering the extracted minute following the subsequent ACPM meeting (2 months after meeting where the application was discussed).

Please note that the alignment of Milestone 6 with the SSP will also provide predictable timeframes. The attached table illustrates the challenge in migrating from the previous "5 working day rule" for ACPM recommendations, in contrast to the "15th of the month rule" for the full outcome statement to be drafted, approved, ratified and delivered.

To implement these changes the TGA will advise each sponsor involved in the specific meeting about the new rules and will continue to do so for the remainder of 2012. We will also use this newsletter to advise all sponsors within the industry.

In addition, it is critical that sponsors fully comply with the requirements for their pre ACPM response. Unfortunately not all sponsors comply and this generates preventable delays and administrative burdens for the process.

*Outcome = recommendation and full minute.

5.2 Pilot of new process and possible efficiencies within the Milestone 6

The TGA has initiated a pilot to test the feasibility and the impact of changes within milestone 6 to reduce the time required to complete this milestone.

The scope of the pilot involved:

• one week delay in due date for the delegates overview
• subsequent one week delay in the due date for the sponsors pre-ACPM response to the Delegates Overview.

Note that the one week delay does not impact on the scheduled ACPM meeting for the application and the sponsor has the same allocation of time to respond to the Delegates Overview.

All sponsors that have an application impacted by this pilot will receive communication from the Secretariat about the proposed changes to the process.

The TGA looks forward to advising sponsors of the outcomes for this pilot and confirmation of any new business rules under the SSP.

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6 - How does the TGA allocate submissions to ACPM meetings?

During the pre-submission phase, the TGA identifies the evaluation resources required for the submission. The evaluation plan and milestone dates for the submission are generated based on the business rules of the SSP, the size and complexity of the submission and the sponsors request for 30 or 60 days to respond to questions asked by the TGA after the first round evaluation. If the PPF is complete and effective, these dates are advised in the planning letter sent at milestone 1 (MS1).

Prior to the March 2012 batch of submissions, if an external evaluator was required, an extra month was added to the evaluation phase to allow this resource to be secured. Improvements to external evaluator procurement practices have now made this unnecessary and the extra month is no longer added. In the rare cases where an external evaluator can not be secured to evaluate a submission within the standard time frames, the TGA will work closely with the sponsor to develop an evaluation plan.

Milestone dates up to Milestone 5 (MS5) are generated according to standard business rules that apply to all submissions, as described in SSP guidance documents. After Milestone 5, there is a 2 week period for sponsors to notify the TGA of any error of omissions in the final evaluation reports relating to their submission. The next step in the SSP is the Delegate's Overview/delegate's request for ACPM advice. This document is the Delegate's summary of the outcomes of the evaluation reports as well as the response by the sponsor to those reports.

The deadline for the Delegate's Overview to be completed and provided to the sponsor and the ACPM is determined by the ACPM Meeting Date. ACPM Meeting Dates are ratified 12-18 months in advance, as shown in Table 1.

Therefore the ACPM Meeting Date applicable to a particular submission is determined by identifying the next Delegate's Overview date after the deadline for sponsors to notify the TGA of any error of omissions in the final evaluation reports, as shown in Table 2.

If Milestone 5 falls on 30 November 2012, the deadline for sponsors to notify the TGA of any errors or omissions in the final evaluation reports is Friday 14 December and the Delegate's Overview for the February 2013 ACPM meeting is due on Monday 17 December. If there are no errors or omissions reported by the sponsor, no amendments are required to the Delegate's Overview so it may be dispatched on Monday 17 December and the submission may proceed to the February 2013 ACPM meeting. However if there is a response from the sponsor to MS5 evaluation reports, there will not be sufficient time to review and incorporate this response into the Delegate Overview by the deadline of 17 December 2012 and the submission will revert to the April 2013 ACPM meeting. Similarly, when Milestone 5 falls on 31 January 2013, the application may go to the April 2013 of June 2103 ACPM meeting depending on whether the sponsor provides a response to the evaluation reports which need to be incorporated into the Delegate's overview.

Copyright

© Commonwealth of Australia 2012

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