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Prescription medicine BPR update newsletter, December 2011

3 January 2012

Introduction

The Prescription medicine BPR update (BPR update) reports on progress in the BPR program. Each month the BPR update reports on the progress of the streamlined submission process.

The December 2011 edition of the Prescription medicine BPR update provides an update on the streamlined submission process, a reminder of the alteration in Product Information documentation, the announcement of case managers and lastly a reminder of Christmas-new year arrangements.

In this edition:

1. Streamlined submission process

1.1 Comment on decision timeframes

To date, the TGA has considered that the overall performance of the streamlined submission process to be positive; however, this assessment has been based on performance against individual milestones. A preliminary analysis of the milestone 7 completions for the November 2010 and December 2010 batches is now available and has revealed the following:

  • New generic applications in these batches were decided, on average, within 8 months of acceptance
  • Changes to product information applications in these batches were decided, on average, within 6.5 months of acceptance
  • Extensions of indication applications in these batches were decided, on average, within 9 months of acceptance

There are a number of major applications (new chemical entity, extension of indication, major variation) received in the November 2010 batch that are yet to be decided. The TGA notes that they are, in general, taking longer than originally anticipated for reasons beyond the control of the TGA and the sponsor. The TGA is continuing to work with the sponsors of these applications to provide transparency of progress and milestone dates.

1.2 Summary of progress to date

The following is a summary of key statistics from applications lodged under the streamlined submission process. For a full record of progress to date under the streamlined submission process, see the attachment.

How to access a pdf or Word document

December 2011 batch

  • 22 PPFs lodged
  • 68% nominated 60-day response period to s. 31 request
  • new entity - 2; new fixed combination - 1; generic - 11; minor variation - 5; major variation - 1
Streamlined submission process - summary statistics
Item Nov-10 Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-11 Sep-11 Oct-11 Nov-11 Dec-11
Pre-submission planning forms
PPFs lodged 28 34 24 25 27 33 28 29 35 26 33 32 24 22
Deficiencies - 12% 12% 24% 30% 24% 7% 28% 25% 31% 30% TBA TBA TBA
Not complete 5 3 2 1 0 0 1 0 0 1 TBA TBA TBA TBA
Submission dossiers
Lodged 23 30 21 21 27 33 27 29 34 TBA TBA TBA TBA TBA
Deficiencies 65% 40% 43% 29% 48% 52% 67% 69% 56% TBA TBA TBA TBA TBA
Not effective 1 0 1 0 0 1 2 1 TBA TBA TBA TBA TBA TBA

1.3 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.

Pre-submission planning form - regulatory requirements
Deficiency TGA requirement TGA workflow impact
Section 1.3 - Product details table - incomplete

Sponsors must complete the product details table in section 1.3 of the PPF. Where the details of the product have been included as an attachment to the PPF, this must be clearly stated in the Product details table.

See-

  • Information for sponsors completing a pre-submission planning form
This information allows the TGA to understand the number and types of products that will require evaluation. Without this information the TGA is unable to assess or arrange the evaluation resources required.
Section 2.3 - Justifications and further information - absent or insufficient

Where the submission requires the provision of biopharmaceutic data but this data will not be provided, for all products, or otherwise does not meet the requirements set out in the relevant EU/TGA documents and guidelines, a robust scientific justification (with references as appropriate) must be included in the submission. Further, where multiple guidelines/requirements have not been met, each must be addressed. The justification must be included either in the space provided on the PPF or provided as a separate attachment to the PPF.

See-

Without justifications, the TGA is unable to fully assess the scope and scale of the submission
Module 2 or equivalent requirements - missing or contain insufficient information

Before completing the pre-submission planning form, sponsors are required to review their dossier and prepare one of the following document sets for attachment with the PPF:

  • A complete draft of Module 2, or
  • Draft summaries of CTD 2.3.S, 2.3.P, 2.4, 2.6.2, 2.6.3, 2.6.4, 2.6.5, 2.6.6, 2.6.7, 2.5, 2.7.1, 2.7.2, 2.7.3, 2.7.4, and/or 2.7.6 as appropriate for the application type, or
  • Documents containing the equivalent information to the draft summaries above.

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. Therefore, the contents of the document are expected to be complete.

To verify a document is to be included in the application, refer to:

Sponsors should also refer to the November 2011 edition BPR Update for requirements of module 2.5 for new generic applications.

Without this information, the TGA is unable to fully assess the scope and scale of the submission or determine if the proposed submission is acceptable.

1.4 Guidance for an effective submission

Submissions that do not meet regulatory requirements will be considered by the TGA to be not effective and not accepted for evaluation.

Guidance for sponsors - submission dossiers
Deficiency TGA requirement TGA workflow impact
Module 1.8.3

A common deficiency in submission dossiers is the failure to provide Module 1.8.3 or to provide a Module 1.8.3 that is compliant with regulatory requirements.

Module 1.8.3 must:

  • be included for all submissions for which a PPF has been lodged
  • contain a declaration that either:
    • states that the submission is consistent with the PPF lodged
    • lists any inconsistencies with an appropriate explanation
  • identify how the sponsor has addressed any issues requiring sponsor action raised by the TGA in the planning letter.

See-

If a submission dossier is required to include module 1.8.3 but this is not provided in the submission dossier at lodgement, the TGA must consider the submission not effective and not accepted for evaluation.
Submission dossier is lodged before the planning letter has been issued

Sponsors must wait until they have received the planning letter from the TGA before lodging their submission dossier.

This will allow sponsors to address any issues raised in the planning letter before lodgement and facilitate efficient processing of the submission dossier.

See-

Sponsors who not address the issues raised in the planning letter, may have their application considered 'not effective'.

Where TGA requests for replacement data to address issues raised in the planning letter, there is likely to be an increase in workload for both sponsors and the TGA.

Dossiers submitted earlier than their due date creates complications with the submission processing, including the need to "park" the dossier in order to process currently due dossiers.

Submission dossier lodged before application fee is received by TGA

In accordance with s.23 of the Therapeutic Goods Act 1989 (the Act), an application cannot be considered effective unless the application fee has been paid.

The TGA will issue an invoice where the application fee has not been paid by the sponsor on lodgement of the pre-submission planning form. Sponsors must ensure that this invoice is paid in advance of the planned milestone 2 date for the submission.

See-

The TGA is unable to consider the application in accordance with the legislation.
Absence of sterility information - new sterile products
  • Sponsors seeking the registration of a new sterile medicine must ensure that their dossier contains all the sterility information set out in section 3.2.P of the Transitional mandatory requirements for an effective submission document, as relevant to their medicine. Where multiple manufacturing sites are used, sterility information must be provided for each site.
The TGA is unable to consider the application to be effective under s.23 of the Therapeutic Goods Act 1989.
Absence of documents related to Risk Management Plan

Where a risk management plan (RMP) refers to educational materials or other supporting documents, those documents are to be provided with a risk management plan.

See-

  • Information for sponsors completing a pre-submission planning form
  • pre-submission planning form
Requesting, collating, issuing and processing of documents outside of the standard submission lodgement process place an additional workload on TGA and the sponsor. This results in an ineffective evaluation of the RMP
Module 1 and module 2 copies

Each submission dossier must contain four copies each of module 1 and module 2.

See-

2. Reminder: new form for Product Information (PI)

The TGA would like to remind sponsors of the alteration in PI documentation referred to in the May and July BPR update. The regulatory requirements for product information documentation came into effect on 12 May 2011 with the registration of the Restricted Medicine Specification 2011.

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.

The November BPR Update contains helpful information for sponsors about the changes in the PI form. Sponsors are advised to consider the new form carefully to ensure full compliance.

3. Case management function

The TGA is continually exploring opportunities to improve its internal and external business processes, with a particular focus on improving efficiency.

As recognised in the early days of the business process reform project, the TGA considers that there may be efficiencies to be gained by having a single point of contact (or case manager) for both sponsors and internal stakeholders. To investigate this further, the TGA will undertake a pilot program of a case management function to support TGA evaluators and delegates and coordinate and track applications through the pre-market authorisation process. The case managers will be the main point of contact for sponsors, as well as internal delegates, administration and evaluation areas.

The case management function will be introduced with the December/January combined batch of submissions. The correspondence to sponsors in relation to their applications will provide contact details for the relevant case manager.

The case managers will expand on the work currently conducted by the Coordination Team and will play a major role in internal business planning to ensure submissions move smoothly though their various processes. The functions of the case managers will include:

  • Tracking of applications based on streams
  • Providing progress reports on applications and issuing reminders to internal stakeholders to ensure that milestones and other key dates are met
  • Early intervention to address arising issues during the journey of the applications
  • Assist with planning and coordination of evaluation resources
  • Identify needs for communication products to be issued and updated
  • Main point of contact for sponsors, administrators, evaluators and delegates
  • Regular feedback to measure effectiveness and improve processes as needed
  • Supporting other case managers as required

To ensure that the case management function operates effectively, we will be seeking feedback from sponsors about their experience with this new function, and make changes to our processes as needed.

4. Reminder of Christmas-New year arrangements

4.1 TGA shutdown

The TGA will close at 3:00 pm on Friday 23 December 2011 and will re-open on Tuesday 3 January 2012. During this period, no TGA personnel will be answering phone calls or monitoring the BPR or streamlined submission process email inboxes. To accommodate this Commonwealth public service shutdown period, the following arrangements will be made.

4.2 Arrangements for December/January batches

As a consequence of the TGA shutdown, PPFs lodged in the December batch (before 1 December 2011) will be processed in accordance with January 2012 batch milestone dates. This means, the planning letter for PPFs lodged in the December batch will not be issued until 15 February 2011.

4.3 Arrangements for other milestone dates

The TGA has made the following arrangements for other milestone dates falling over the Christmas-new year period. The TGA has considered these arrangements carefully so as to not impact on eligibility for planned ACPM meetings.

The TGA estimates that approximately 100 submissions currently in the streamlined submission process that will be impacted by these arrangements. Sponsors should ensure they are familiar with these arrangements as the TGA may not be able to issue revised dates on a submission-by-submission basis until the next milestone.

Streamlined submission process - Christmas-new year arrangements
Milestone/phase Affected batch/es* Original due date Revised due date Comments
MS1
PPF (December batch)
Dec 2011 15 Jan 15 Feb

Milestones for all December PPFs will be aligned with those of the January batch of PPFs. The default dates for both December and January batches will therefore be:

  • submission dossier lodged by COB 14 March
  • milestone 2 - 31 March 2012
  • milestone 3 - 31 July 2012 (assuming default evaluation period)
MS2
Outcome of submission consideration sent
Oct 2011 31 Dec 2011 16 Jan 2012 The milestone 3 for these submissions will be extended to align with the end of the month. This means the timeframe for milestone 3 for this batch will be 4½ or 5½ months (depending on response timeframe to s. 31 request nominated) rather than 4/5 months.
MS3
Outcome of 1st round assessment sent
May 2011
Jun 2011
31 Dec 2011 21 Dec 2011 Due dates for relevant responses will be remain as specified in the planning letter to ensure statutory timeframes are met.
MS4
End of s.31 response period
Mar 2011
Apr 2011
May 2011
31 Dec 2011 3 Jan 2012 As the TGA will not be open to accept deliveries or post during the shutdown period, the due date for sponsors to deliver their responses is extended to the first working day of the new year.
MS5
Outcome of assessments sent
Feb 2011
Mar 2011
Apr 2011
31 Dec 2011 16 Jan 2012 The sponsor's response period to advise the TGA of any errors of fact or omission in the evaluation report/s will be maintained at two weeks.
MS7
Decision made by delegate
Nov 2010
Dec 2010
31 Dec 2011 case-by-case The TGA will, wherever possible, complete the decision phase before the Christmas shutdown.
MS8
Administrative and regulatory activities complete
Nov 2010
Jan 2011
31 Dec 2011 case-by-case The TGA will, wherever possible, complete the post-decision phase before the Christmas shutdown. Note, however, that there are sponsor dependencies.

*This information is provided as a guide only and sponsors should check the most recent milestone letter from the TGA for each submission to determine if it is affected by these arrangements.

© Commonwealth of Australia 2011
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