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Prescription medicine BPR update newsletter, February 2011

10 February 2011

Introduction

The February edition of the Prescription medicine BPR update newsletter focuses on the streamlined submission process project.

In this edition:

  • progress to date under the streamlined submission process, including TGA performance against milestones
  • common problems with PPFs
  • guidance for an effective submission.

The TGA is pleased with progress to date under the 12-month transition period, and is engaged in ongoing work to ensure documents specifying the regulatory requirements for the streamlined submission process are updated as necessary in light of experience with the new process.

The TGA appreciates the feedback it has been receiving on the streamlined submission process from sponsors and encourages sponsors to email the BPR project with any questions. The information gathered from this process assists in refining the regulatory documents and supporting material.

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

Streamlined submission process project

Progress to date

The following table provides a summary of the November, December, January, and February batches of PPFs received under the streamlined submission process, and the TGA's performance against milestones 1 and 2.

  Batch
Item November December January February
Pre-submission planning forms
Date processing PPFs commenced 1 Nov 10 1 Dec 10 1 Jan 11 1 Feb 11
Number of PPFs received by processing date 28 33 24 25
Section 31 response period - sponsor nominated 60 day 46% 70% 48% 48%
Assessment status
Number incomplete 5 3 pending pending
Number with minor deficiencies (48 hours to address) To be included in future reports
Progress to planning letter 23 30 pending pending
Application type
New entity - A 2 4 3 2
New fixed dose combination - B 0 1 1 1
Extension of indication - C 10 3 5 0
Generic - D 8 9 8 11
Minor variation - J, G, H 4 9 6 7
Major variation - F 3 5 5 4
(multiple application types) 2 with 3 1 with 2 4 with 2 -
M1 - Outcome of pre-submission sent
M1 target date 15 Dec 10 15 Jan 11 15 Feb 11 15 Mar 11
Number met target date 23 30 on track pending
M2 - Outcome of submission consideration sent
M2 target date 31 Jan 10 28 Feb 11 31 Mar 11 30 Apr 11
Number with minor deficiencies (48 hours to address) 15 pending pending pending
Number met target date 21* pending pending pending
Number effective notification letter 20      
Number not effective notification letter 3 pending pending pending

* Note: all sponsors, with the exception of two, were advised by email on the status of their submission prior to this milestone date. The TGA was unable to email the two sponsors due to problems with sponsor email. Fifteen submissions qualified for the 48-hour response time to address submission deficiencies and all complied with this requirement to enable the consideration of submissions and delivery of notification letters on 7 February 2011 as advised in the initial email contact.

Pre-submission planning form - regulatory requirements

There are a number of documents which outline the regulatory requirements for a pre-submission planning form (PPF), including:

The following information draws on common issues identified with PPFs submitted in the November, December, January, and February batches. This information will assist sponsors in meeting the regulatory requirements of the streamlined submission process.

Problem TGA requirement
Attachments missing

The TGA has received PPFs with the following attachments missing:

  • product information
  • proof of preconditions.

See

The pre-submission planning form identifies the attachments required. Compulsory attachments are marked with a double asterisk.

GMP issues

Some issues identified with GMP information include:

  • no renewal for GMP scheduled to expire
  • no GMP clearance application pending
  • GMP clearance insufficient for processes to be carried out at site.

See

Appendix C of Information for sponsors completing the pre-submission planning form.

Sections of PPF not completed

Some sections of the PFF are not complete, including:

  • volume information
  • product details.

See

Information for sponsors completing the pre-submission planning form.

Guidance for an effective submission

The TGA has considered 20 submissions from the November batch to be effective and therefore accepted for evaluation. Three submissions from the November batch were considered not effective and not accepted for evaluation.

At the time of submitting a PPF, sponsors sign a declaration that confirms their understanding of the regulatory requirements for an effective submission dossier.

These regulatory requirements are set out in a suite of documents, including:

In addition, documents outline the regulatory requirements for modules 2 to 5.

In response to a call for further clarification on the regulatory requirements for electronic submissions and active links, the TGA will be publishing an updated version of:

The following information identifies some regulatory requirements which are not being met, thereby risking that a submission will be considered not effective.

Problem TGA requirement
Submission dossier substantially different from information provided in PPF

If there is a discrepancy between the PPF and the actual scope and scale of the submission provided, the TGA will consider whether the submission dossier is sufficiently different from the information provided in the PPF to justify the submission being considered not effective.

Where there is a discrepancy that does not affect the scope and scale of the submission, sponsors must account for the discrepancy in module 1.8.3, and also highlight the issue in the submission cover letter.

Where the scope and scale of a submission is affected (for example, the number of volumes submitted is different to that specified in the PPF), sponsors must account for the discrepancy in the cover letter. For example, a table that indicates planned volumes versus actual volumes, and provides an explanation, is acceptable.

See

Module 1 forms not completed

The transitional draft CTD Module 1 - January 2011 specifies the forms required for Module 1.

There have been some delays in publishing the new streamlined submission process forms and letter templates separately on the TGA website. Until these are published, sponsors should use the versions provided in the November 2008 version of CTD Module 1.

No active links in the table of contents of electronic copy of submission dossier

For electronic submission dossiers submitted in NeeS format, all documents are to be linked from a table of contents.

The Guidance for industry on providing regulatory information in electronic format: Non-eCTD electronic submissions (NeeS) for human medicinal products will be updated shortly to make this requirement clearer.

Mandatory requirements not met

Some common issues concern:

  • GMP information (Module 1)
  • bioequivalence study information or an approved justification for not meeting the relevant appropriate guidelines (Modules 1 and 5)
  • quality study information, or an approved justification for not meeting the relevant appropriate guidelines (Module 3).
Packaging requirements

Packaging requirements The TGA is required by law to retain submission dossiers for 70 years. To ensure dossiers remain intact and legible throughout this period, the TGA stores dossiers in acid-free archival boxes. Sponsors should ensure their submission dossiers are acid-free (including the binders and inserts).

Other requirements relating to the packaging and presentation of information include:

  • binders must not be overfilled
  • all data exceeding 20 pages must be bound
  • where possible, external dimensions of binders should not exceed 270mm wide x 320mm high x 80mm thick
  • submission dossiers must be packaged to arrive at the TGA in an undamaged state.

See

Further information is provided in transitional draft CTD Module 1 - January 2011.

Contact the BPR team

PO Box 100
Woden ACT 2602

© Commonwealth of Australia 2011

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