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Prescription medicine BPR update newsletter, April 2012

30 April 2012

Introduction

The Prescription medicine BPR update (BPR update) reports on progress of the streamlined submission process. Each quarter, an update is provided on the PI/CMI project and the AusPAR project.

In this edition:

1. New name for the BPR update

The BPR newsletter was introduced to communicate updates and issues relating to the implementation of the streamlined submission process for prescription medicines. This involved a business process review (BPR) followed by the implementation of the streamlined submission process (SSP) in November 2010. This new process is now business as usual. Given that the SSP is just out of the transition period, there remains a need for the TGA to communicate information and issues to our industry stakeholders. Feedback from the Industry Working Group identified the BPR Update as a useful way to do this. Therefore, we will continue to publish a regular update newsletter, but commencing with the next edition, it will be called the TGA Prescription Medicines SSP Newsletter (SSP Newsletter).

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 to date. 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.

  • February 2012 batch
    • 35 PPFs lodged
    • 57% nominated 60-day response period to s. 31 request
    • Included:- new entity - 2; new fixed combination - 1; generic - 11; minor variation - 14; major variation - 2
  • March 2012 batch
    • 26 PPFs lodged
    • 88% nominated 60-day response period to s. 31 request
    • Included:- new entity - 2 new fixed combination - 2; generic - 15; minor variation - 1; major variation -1; changes to PI - 5
  • April 2012 batch
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 Jan-12 Feb-12 Mar-12 Apr-12
Pre-submission planning forms
PPFs lodged 28 34 24 25 27 33 28 29 35 26 33 32 24 22 46 35 26 40
Deficiencies - 12% 12% 24% 30% 24% 7% 28% 25% 31% 30% 13% NA NA NA NA NA NA
Not effective 5 3 2 1 0 0 1 0 0 1 0 3 3 5 3 1 3 TBA
Submission dossiers
Lodged 23 30 21 21 27 33 27 29 34 24 29 30 19 18 45 TBA TBA TBA
Deficiencies 65% 40% 43% 29% 48% 52% 67% 69% 56% 46% NA* NA NA NA NA NA NA NA
Not effective 1 0 1 0 0 1 2 1 1 1 2 1 TBA 3 1 (TBA - 3) TBA TBA TBA

* Deficiencies in the PPFs and submission dossiers are not applicable (N/A) for these batches due to the end of the transitional 48 hour grace period on 31 Oct 2011. Please refer to the November 2011 BPR Update regarding that announcement.

Section 31 letter

100% of the Section 31 letters due to be sent in the month of March were sent on time.

Results of second round evaluations

94% of the second round evaluations that were due to be sent out in March were sent on time.

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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. During the reporting period one NCE was completed.

Workflow analysis before and after the streamlined submission process
Application type Days elapsed from acceptance to decision
Pre streamlined submission process Streamlined submission process
Period when decision finalised Oct-Dec 2010 Jan-Mar 2011 Apr-June 2011 Jul-Sep 2011 Oct-Dec 2011 Oct-Dec 2010 Jan-Mar 2011 Apr-June 2011 Jul-Sep 2011 Oct-Dec 2011 Jan-Mar 2012
New Generic - type D
Average Calendar Days 425 412 399 409 395 - - - - 196 231
Average Work days 227 212 216 213 213 - - - - 123 137
New Chemical Entities
Average Calendar Days 379 467 443 457 395 - - - - - 326
Average Work days 190 237 228 237 225 - - - - - 204
Extension of Indication - type C
Average Calendar Days 404 348 423 398 333 - - - - 279 201
Average Work days 236 209 258 215 210 - - - - 100 117
Major Variation - type F
Average Calendar Days 274 393 345 394 355 - - - - - 246
Average Work days 168 207 199 211 204 - - - - - 140

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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.

Pre-submission planning form - regulatory requirements
Deficiency TGA requirement TGA workflow impact
Section 1.7 - GMP license or clearance scheduled to expire

It is a TGA requirement that for all manufacturers and finished product testing facilities involved in the active ingredient and/or product manufacture the sponsor must provide GMP licences or clearances with validity for at least 6 months after the scheduled full submission date.

If, the GMP licences or clearances are due to expire in this period of time then the Certification Tracking Number for the renewal application lodged with the Office of Manufacturing Quality (OMQ) must be provided in Module 1.7.3 of the PPF.

For more info:

The TGA uses manufacturing licences (for Australian manufacturing sites) and good manufacturing practice (GMP) clearances (for overseas sites) to establish whether the manufacturing/processing standards are acceptable.

Without valid manufacturing licences or GMP clearances, the TGA cannot evaluate the submission.

Section 1.6 - Drug Master File (DMF)

If the pre-submission form indicates that the submission will be making a reference to a Drug Master File then it is a TGA requirement that the Drug Master File number is provided in Section 1.6 of the PPF and the DMF is supplied both electronically and in hard copy prior to the submission dossier.

For more info:

The TGA requires that relevant DMF copies and details are provided with the PPF to enable access to information regarding the active substance at the time of submission. Without this information the TGA is unable to access essential information and evaluate the submission.

Part 2 - Details of submission

The TGA is aware that there remain different understandings across industry regarding the TGA requirements to determine the scope and scale of an evaluation.

The TGA would like to confirm that to ensure a PPF is accepted the requirements, instructions and explanations in the current (March 2011) PPF form and Information for sponsors completing a pre-submission planning form published on the TGA website is to be adhered to.

Any alterations to the requirements will be only through the modification of the PPF form and associated publications.

For further questions contact the case management team: streamlinedsubmission@tga.gov.au

TGA requires the necessary information to arrange appropriate resourcing for the processing and evaluation of an application, including where relevant, the contracting of external evaluators.

The information provided in the PPF allows the TGA to commit to timeframes for the evaluation of the application.

2.4 Streamlined submission process - first review

The TGA is currently conducting a review of the performance of the streamlined submission process to date with a view to indentifying refinements and pressure points that are barriers to meeting milestone dates. The initial stages of the project will focus on milestones 5 to 8. The TGA will engage with the Industry Working Group on proposed refinements and solutions to identified pressure points, including communicating the outcomes and any process changes to address the identified process improvements.

2.5 Milestone dates

The streamlined submission process is based on a series of 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.

Since May 2011, the TGA has generally not been able to 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 manager function, which was implemented in December 2011. The TGA announced this development in the December 2011 BPR Update.

Early indications show that these actions are having an impact. For instance, 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, it indicates that in the next few months we should see more milestone dates being met. The TGA is collating information that will allow more accurate reporting against this performance indicator.

3. Management of physical dossiers

Over the Christmas - New Year period, the TGA was required to revise administrative arrangements for the handling of a small number of hardcopy submissions provided in non-standard folder sizes.

The TGA would like to reiterate the hardcopy format constraints to Sponsors (CTD Module 1 Part A Mandatory requirements for hardcopy submission dossiers). To ensure efficient streamlined processing of hardcopy submissions upon receipt at the TGA, external dimensions of folders should not exceed 270mm wide x 320mm high x 80mm thick.

Submissions comprised of folders larger than the specified dimensions may be subject to delays due to the additional effort required by records management staff in processing the submission.

The TGA is currently considering options for preventative action to ensure all submission dossiers can be processed efficiently.

4. Case management

The case management function announced in the December 2011 BPR update is being rolled out with the December 2011/January 2012 combined batch of submissions.

The functions of the case managers are to support TGA evaluators and delegates and to coordinate and track applications through the pre-market authorisation process. They will establish and maintain a central coordination role in monitoring applications across the different prescription medicines evaluation areas from the pre-submission phase through to the final decision phase. The case management team will also seek regular feedback to measure effectiveness of the streamlined submission process and propose business processes improvements as needed.

The case managers will be the main point of contact for sponsors, as well as internal delegates, administration and evaluation areas and the ACPM Secretariat. They will be well placed to respond to sponsor needs and concerns, both application-related and more broadly via the Industry Working Group (IWG).

All contact with case managers should be conducted through the streamlined submission mailbox:

The TGA requests that sponsors address the subject line in the following manner:

  • PM-XXXX-XXXXX-X-X Sponsor name active ingredient.

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5. Fee arrangements

5.1 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 pre-submission planning form (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 online lodgement system (eBS). These changes are complete and applicants can now generate electronic invoices for application fees upon lodgement of their pre-submission planning form (PPF).

5.2 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).

5.3 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.

5.4 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).

6. Product information/Consumer medicines information documents

6.1 Overview of PI/CMI collection

The TGA aims to improve access for consumers and health professionals to information about prescription medicines by providing a single trusted internet source for PI and CMI documents.

To achieve this, the TGA collects the following:

  • PI documents for all prescription medicines registered on the Australian Register of Therapeutic Goods (ARTG), whether they are marketed or not
  • CMI documents for all registered prescription medicines on the ARTG that are being marketed in Australia.

In addition to supplying PI and CMI documents for existing registrations, sponsors must lodge PIs and CMIs with the TGA following approval of applications for new and varied products. Lodgement of PI and CMI documents must be completed electronically via the secure eBS facility.

Published PI and CMI documents are available on the TGA eBS website at www.ebs.tga.gov.au under 'Public TGA information'.

6.2 PI/CMI progress

The following table shows progress in publishing PI and CMI documents as at 20 February 2012.

Publication of PI/CMI documents
Document As percentage of prescription medicine entries on the ARTG
January 2011 March 2011 June 2011 November 2011 February 2012
PI 71% 81% 84.93% 83.18% 86.41%
CMI 54.3% 58.29% 55.57% 56.96% 58.67%
Total ARTG entries 10,043 10,125 10,838 11,025

6.3 Uploading the documents

A product information (PI) or consumer medicines information (CMI) document is only to be lodged once all changes made are considered acceptable by the TGA and the sponsor has received formal approval or acknowledgement in the form of a signed letter from the TGA delegate. This applies to category 1, category 2, category 3, Safety Related Notification (SRN), Self Assessable Notification (SAN) and Minor Editorial Change (MEC) applications. Documents are not to be lodged on the TGA eBS PI/CMI facility until such time that approval has been granted.

7. Australian Public Assessment Reports (AusPAR)

7.1 AusPAR progress to date

The following table provides an update on AusPAR progress to 28 February 2012.

AusPAR progress
Status Number
as at 31 Dec 2010 as at 30 April 2011 as at 30 Jun 2011 as at 1 Dec 2011 as at 28 Feb 2012
Total drafted 108 126 146 161 181
Released on TGA website 74 102 116 146 164
With sponsors for comment 4 7 6 6 8

Waiting for either:

  • the appeal period for the delegate’s decision on the application to end
  • the result of an appeal in relation to the delegate’s decision prior to the document being released
2 4 6 1 3
Initial draft complete and waiting for the delegate's decision 16 6 - 4 5
Undergoing final internal TGA quality assurance review 12 7 10 4 1

7.2 Contact

For further enquires please email: auspars@tga.gov.au

© Commonwealth of Australia 2011
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