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Prescription medicine BPR update newsletter, January 2011

20 January 2011

Introduction

In early 2009, the TGA commenced a program of business process reforms (BPR program) for the regulation of prescription medicines. These reforms include:

  • Streamlined submission process project - aiming to improve submission quality and provide predictable timeframes for the evaluation and registration of prescription medicines
  • PI/CMI project - providing from November 2009 a single trusted source for product information (PI) and consumer medicine information (CMI) on the TGA website resulting in enhanced access to prescription medicine information
  • AusPAR project - increasing the transparency of the regulation process from December 2009 by publicly releasing Australian Public Assessment Records (AusPAR) for new products or major variations to existing products.

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

Streamlined submission process project

The 12-month transition period for the implementation of the new streamlined submission process began on 1 November 2010. The new process applies to all category 1 and 2 submissions, with the exception of additional trade name submissions.

The new process is set out in Transitional prescription medicine streamlined submission process. The new process includes defined phases and milestones to assist in the establishment of predictable timeframes.

Other key reforms introduced as part of the streamlined submission process include:

  • pre-submission and planning phases
  • assistance to sponsors to improve the quality of submission dossiers
  • a single consolidated set of s. 31 requests
  • sponsor nomination of s. 31 request response time
  • management and reporting of submission progress across eight milestones.

Planning letter milestone dates - example

At the end of the pre-submission phase, the TGA issues a planning letter for each pre-submission planning form (PPF) accepted. The planning letter sets out the milestone dates that will apply to the submission.

The following example shows the milestone dates for a PPF lodged with the TGA before 1 November 2010. The TGA commenced assessing the PPF and supporting data on 1 November 2010 as part of the 'November batch'.

Milestone Date
Milestone 1- Outcome of pre-submission sent 15 Dec 2010
Milestone 2 - Outcome of submission consideration sent 31 Jan 2011
Milestone 3 - Outcome of 1st round assessment sent 31 May 2011
Milestone 4 - End of s. 31 response period (60 day response proposed) 31 July 2011
*target Milestone 5 - Outcome of assessments sent 31 Aug 2011
*target Milestone 6 - Outcome of advisory committee sent (if referred) 15 Dec 2011
*target Milestone 7 - Initial decision made by delegate 31 Dec 2011
*target Milestone 8 - Administrative and regulatory activities complete 31 Jan 2012

* During the 12 month transition period from 1 November 2010, the dates for milestones five to eight are target dates that the TGA will endeavour to meet. The transition period provides the opportunity to consider the workability of the proposed timelines.

It should be noted that this information is provided as an example only and should not be used as a guide for sponsors who are planning the lodgment of pre-submission planning forms and submission dossiers. The Q&A page on the TGA website provides further information that may be of assistance for sponsor planning purposes. However, the dates specified in the planning letter remain the formal milestone dates for a given submission.

Progress to date

The TGA is encouraged by the general quality of PPFs received so far and the commitment of sponsors to the new process as demonstrated in the initial batches. The TGA thanks sponsors for their feedback and support as the processes are further refined.

The table below provides a summary of the November, December and January batch of PPFs received under the new process, and the TGA's performance.

  Batch
Item November December January
Pre-submission planning forms
Date processing PPFs commenced 1 Nov 10 1 Dec 10 1 Jan 11
Number of PPFs received by processing date 28 33# 23
Section 31 response period - sponsor nominated 60 day 46% 70% 48%
Assessment status
Number incomplete 5* 3 pending
Number with minor deficiencies (48 hours to address) To be included in future reports
Progress to planning letter 23 30 pending
Application type
New entity - A 2 4 3
New fixed dose combination - B 0 1 1
Extension of indication - C 10 3 5
Generic 8 9 7
Minor variation 4 9 6
Major variation 3 5 5
(multiple application types) 2 with 3 1 with 2 4 with 2
Outcome of pre-submission sent - M1 status
M1 target date 15 Dec 10 15 Jan 11 15 Feb 11
Number met target date 23 30 on track
Outcome of submission consideration sent - M2 status
M2 target date 31 Jan 10 28 Feb 11 31 Mar 11
Number met target date on track pending pending

* In recognition of the significant changes and the need for ongoing refinement and clarification of TGA regulatory requirements, the TGA decided to allow four PPFs in the November batch to be processed as part of the December batch, as soon as the sponsors had addressed the information issues identified. The remaining incomplete PPF could not be processed for legal reasons.

# This number includes the four PPFs held over from the November batch.

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Key areas for sponsor improvement

Overall, the TGA is pleased with the standard of pre-submission planning forms received under the streamlined submission process and how well sponsors have adapted to, and met, the new requirements. Some of the issues that have emerged are:

  • at the pre-submission phase
    • module 2 or module 2 equivalent requirements
    • good manufacturing practice (GMP) information
    • document file names
  • at the submission phase
    • missing items and information.

Module 2 or equivalent

The TGA recognises that the requirement to provide information equivalent to module 2 when submitting a PPF is a significant change for sponsors. This information allows the TGA to assess the scope and scale of the submission, assign resources, and commit to milestone dates. The TGA is consulting with the Industry Working Group (IWG) to develop tools to facilitate compliance with this requirement by sponsors.

GMP information

Sponsors are advised to review the updated supporting information about good manufacturing practice (GMP) requirements for the pre-submission phase that have been provided in the following documents:

  • pre-submission planning form (January 2011 version)
  • Information for sponsors completing a pre-submission planning form (January 2011 version).

Information from the IWG and the TGA's experience with the first two batches informed the changes to these documents. The updated information will increase the clarity of the requirements.

Sponsors are reminded this information is critical for the TGA to coordinate its internal processes so evaluation and decision processes are not delayed.

Document file names

Document file names for attachments submitted with the PPF must clearly identify the content of the document. For example, a document named 'supporting data' does not allow the TGA to identify the content of the document without opening it. Examples of appropriate document file names for attachments include:

  • Draft PI - name of product
  • Module 2 - section(s) specified - e.g. Module 2.3.S, Module 2.3.S and 2.3.P
  • Manufacturer information
  • Orphan drug designation approval.

Missing items and information

The TGA has commenced processing category 1 submissions lodged in January from the November batch of PPFs. The table below identifies some more commonly occurring problems with submissions and provides further guidance.

Problem TGA requirement
Only one (1) copy of CD/DVD containing the electronic copy of the submission and supporting data provided

Six (6) copies of the CD/DVD containing the electronic copy of the submission and supporting data are required.

See 'Part A - General requirements for applications' of transitional draft CTD Module 1 - Administrative information and prescribing information for Australia - January 2011.

Letters of application omitting:

  • details of the page count for each module
  • declaration that the hard copy dossier and electronic copy dossier provided to the TGA are identical, or if not identical, a specification of the differences

The letter of application must provide this information.

See 'Part B - Format of Module 1' of transitional draft CTD Module 1 - Administrative information and prescribing information for Australia - January 2011.

Number of volumes submitted for one or more modules in the submission dossier is substantially different from the number advised in the PPF

The TGA uses the volume estimates provided in the PPF to assess the scope and size of the submission and thus develop an evaluation plan for the submission. If there is a discrepancy between the PPF estimates and the actual scope and scale of the submission, the TGA will need to consider whether the submission dossier is sufficiently different from the information provided in the PPF that would justify the evaluation not proceeding on the grounds that the submission would be considered not effective.

Where there is a discrepancy that does not affect the scope and scale of the submission, sponsors should account for the discrepancy in Module 1.8.3 (e.g. estimates quoted as single-sided dossier but provided as double sided, or additional documents provided in dossier as requested by TGA in the planning letter).

Where the scope and scale of the submission is affected, sponsors should contact the TGA prior to submission lodgement as soon as they become aware of any changes.

See

  • Module 1.8.3 of transitional draft CTD Module 1 - January 2011
  • 'There are some differences between the information provided in my PPF and the submission. What do I do?' on the Q&A page on the TGA website.
Damaged folders resulting from poor packaging

Bubble wrap is the most effective means for packaging folders to prevent damage. The TGA requests sponsors do not use polystyrene beads to fill gaps in boxes as this does not provide sufficient protection to prevent damage, and is an occupational health issue for staff.

See 'Part A - General requirements for applications' of transitional draft CTD Module 1 - Administrative information and prescribing information for Australia - January 2011.

Incorrect labelling of volumes, for example: 1A, 1B, 2A, 2B, etc.

Volumes in each module must be numbered separately and sequentially using the format: x of y volumes, where x is the number of the specific volume and y is the total number of volumes submitted for the respective module, for example: Module 3, Vol. 1 of 6.

See 'Part A - General requirements for applications' of transitional draft CTD Module 1 - Administrative information and prescribing information for Australia - January 2011.

Electronic copies of submission dossiers not provided in the correct format

The TGA will accept electronic copies in either non-eCTD electronic submission (NeeS) format or eCTD format.

See draft Guidance for industry on providing regulatory information in electronic format: Non-eCTD electronic submissions (NeeS) for human medicinal products.

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TGA activities

Assistance to sponsors at the pre-submission phase

In recognition of the impact of the new streamlined submission process, the TGA worked with sponsors through the first November batch of pre-submission planning forms and held over four PPFs where deficiencies had been identified, to the December batch.

The TGA will continue to support sponsors in the new streamlined submission process. However, the TGA will not be able to support holding over pre-submission planning forms from one batch to the next. Instead, sponsors will be given two opportunities to rectify deficiencies in their pre-submission planning form:

  • On receipt of the pre-submission planning form, an administrative check will be performed. The sponsor will be notified of any deficiencies identified and given 48 hours to rectify the issues.
  • On completion of the administrative check, a technical check will be performed by the relevant evaluation area(s). The sponsor will be notified of any deficiencies identified and given 48 hours to rectify those deficiencies.

Where the sponsor is unable to address the deficiencies within the allocated timeframes, the TGA undertakes to advise the sponsor in writing as soon as possible that the pre-submission planning form was considered incomplete. The TGA will not wait until the target date for milestone 1 to issue the advice, allowing the sponsor to prepare a new pre-submission planning form for the next available batch (assuming the sponsor wishes to proceed with the submission).

Revised regulatory documents

Providing clarity on the requirements and forms in the streamlined submission process is an area of ongoing refinement. The TGA has published a revised set of regulatory documents which have been updated to take into account feedback from a range of sources including:

  • skills training workshops
  • comments sent to the BPR email address
  • the IWG
  • TGA experience with the three batches of PPFs received to date.

The following documents were published on 4 January 2011:

The following documents were published on 17 January 2011 and take effect on 1 March 2011:

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PI/CMI project

(increased access to information)

Publication on TGA website

The PI/CMI project seeks to improve access for consumers and health professionals to information about prescription medicines by providing a single trusted internet source for product information (PI) and consumer medicine information (CMI) documents.

To achieve this, the TGA collects the following:

  • PI documents for all registered prescription medicines on the Australian Register of Therapeutic Goods (ARTG)1
  • CMI documents for all registered prescription medicines on the ARTG that are being supplied in Australia.

1 The TGA acknowledges there are a number of registered prescription medicines which, for a range of legitimate reasons, may not have a PI.

In addition to supplying PI and CMI documents for existing registrations, it is a requirement that sponsors lodge PIs and CMIs with the TGA following approval of submissions for new and varied products. The requirements for PI and CMI lodgement are identified in the approval letter and can also be found on the Improved access to information page on the TGA website. Lodgment of PI and CMI documents must be completed electronically via the secure eBS facility or healthlinks.net (see TGA activities section below).

Published PI and CMI documents are now available on the TGA eBS website under 'Public TGA information'.

PI/CMI progress

The following table shows the TGA's progress in collecting PI and CMI documents as at 31 December 2010:

Document Percentage of prescription medicine entries on ARTG for which the document has been collected
PI 71%
CMI 54.3%

Key areas for sponsors

Format of documents

The TGA is aware that sponsors would prefer to display trade mark and/or copyright symbols within their medicines' trade names. However, the eBS system does not accept or publish these non-standard characters and sponsors are requested to omit them.

Replacing or lodging a new document

A 'replace' function is now available using the 'Consumer medicine and product information' option under 'Your TGA information' on eBS. If sponsors are not sure whether they should be using the replace function or lodging a new document, email prescriptions.pi@tga.gov.au for clarification.

Lodging through healthlinks.net

The TGA is now receiving documents lodged by sponsors through healthlinks.net for new registrations and replacements of previously lodged documents. Sponsors must ensure documents lodged through healthlinks.net are received by the TGA within the timeframe(s) specified in the approval letter. 'Not for publication' documents must be lodged with the TGA directly via the eBS.

TGA activities

Backcapture

The TGA has commenced a process for ensuring:

  • PIs and CMIs for prescription medicines currently on the ARTG have been lodged
  • lodged PIs and CMIs are the latest approved versions.

Sponsors with prescription medicine ARTG entries not accompanied by a PI or CMI, or the correct version, are receiving letters requesting lodgement of the relevant document. The TGA will audit a sample of lodged PIs and CMIs to ensure they are the latest approved versions.

Authorised agents

The TGA is working to enhance the PI/CMI lodgement system in eBS to allow authorised agents to lodge PIs and CMIs on behalf of sponsors.

Contact

Email: prescriptions.pi@tga.gov.au.

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AusPAR project

(increased transparency)

Sponsor review

The TGA has been publishing AusPARs for over 12 months. An important feature of this process is the opportunity for sponsors to review the draft AusPAR prior to publication. While the primary aim of sponsor review is for the sponsor to identify any commercially confidential material which may be present in the AusPAR, many sponsors take the opportunity to review the document in detail, identifying any perceived errors in grammar, syntax, or the data presented. The TGA welcomes this contribution.

Some sponsors have objected to the publication of comments made by an evaluator, the delegate, or the ACPM. The TGA will consider comments from the sponsor on the information or advice of the evaluator, the delegate, or the ACPM. However, an AusPAR is an account of the TGA evaluation and must reflect the opinions and considerations of the TGA evaluators, advisory committees, and decision-makers at each stage of the evaluation.

Commercially confidential material

The identification and deletion of commercially confidential material has been relatively straightforward. The Appendix to the AusPAR guidance document provides a summary of the principles that are applied to the identification and deletion of such material. In general this applies to the quality section of the AusPAR and not to the non-clinical or clinical sections. Exceptions to this include specific details on a method used in a study, which upon justification from the sponsor, could be regarded as trade secret or information which might in some circumstances be regarded as part of a development plan from the sponsor.

AusPAR progress

The TGA is focussing on preparing AusPARs for submissions that have been considered by Advisory Committee on Prescription Medicines (ACPM). As at 31 December 2010, of the 108 AusPAR documents drafted:

Status Number
Released on TGA website 74
With sponsors for comment 4

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
Initial draft complete and waiting for the delegate's decision 16
Undergoing final internal TGA quality assurance review 12

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IWG report

The Industry Working Group (IWG) met on 19 November 2010. The outcomes summary below provides information on actions and status to ensure transparency for sponsors.

Action Status
1 Introduction and Overview
1.1 Action Nov 10/1 - TGA to contact AusBiotech to confirm status of IWG membership and to identify mechanisms for communication with their members. complete
2 Items for Noting
2.1 General - overview
Action Nov 10/2a - TGA to advise on eBS changes to enable editing/revisions to PPF or changes to attachments. ongoing
Action Nov 10/2b - TGA to ensure Q&A and help notes provide information to support sponsors. complete
Action Nov 10/3 - Members/TGA to encourage sponsors to deliver all available information in the PPF and to seek clarification if uncertain. ongoing
Action Nov 10/4 - TGA to respond to enquiries via BPR email within 2 working days, wherever feasible. ongoing target
2.2 Skills training
Action Nov 10/5 - TGA to conduct the next series of skills training in June/July to coincide with milestone 4 (End of s. 31 response period) of the streamlined submission process and the release of the refreshed ARGPM, and contact ARCS to ensure the BPR project is a keynote address at the September 2012 conference in Canberra. planning underway
3 Items for discussion/decision
3.1 Performance measures workshop
Action Nov 10/6 - TGA to present members with a draft set of performance measures that match TGA's capacity and systems capabilities for approval at the February 2012 meeting. on target for Feb meeting
3.2 PPF phase
Action Nov 10/7 - TGA to meet with IWG subgroup to consider templates and guidance to clarify module 2 equivalent requirements. complete - template under development
Action Nov 10/8 - TGA to release revised forms and regulatory documents allowing for 2 months of lead time before compliance with the changes are mandatory. complete - 17 Jan 11 release of suite of regulatory documents for 1 March 11 implementation
Action Nov 10/9 - TGA to further refine the set of pre-conditions. ongoing
Action Nov 10/10 - TGA to consider the following change to the PPF in the 1 January release: clarification of related submission requirements. further consideration and consultation required
Action Nov 10/11 - TGA to confirm security of email documents. further consultation required
3.3 Literature based submissions
Action Nov 10/12 - TGA to implement the agreed improvements to the literature based submission (LBS) process to clarify the literature based search requirements, compliance with which is now a pre-condition to lodgement of a PPF. consultation complete, pending documentation
3.4 Mandatory requirements/submission
Action Nov 10/13 - TGA to propose a standard for the structure and file naming conventions for electronic submission dossiers for member approval prior to implementation. draft NeeS guidancepublished 4 Jan 11
3.5 Communication activities

Action Nov 10/14 - TGA to develop BPR update with first edition to include information on:

  • general statistics for Nov and Dec PPF batches
  • advice on refresh to suite of 5 forms and documents and timeframes for when their use is mandatory
  • rationale for module 2 requirements.
complete - 1st edition 17 Jan 11
Action Nov 10/15 - Members to provide comment, and advise on best dissemination channels. ongoing
3.6 Post transition fee arrangements
Action Nov 10/16 - TGA to seek advice from IWG members prior to the presentation on new fee arrangements scheduled for the February 2011 bilateral meeting. on track

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Other news

Changes to the Act

The program of legislative change to support the business process reforms for prescription medicines is underway. The following minor amendments to the Act came into effect on 12 January 2011:

  • formalising the process for the lodging and approval by the Secretary, of product information
  • clarification of the procedures in s.9D of the Act for varying entries in the ARTG
  • allowing for sponsor-determined response times for s. 31 requests.

Contact the BPR team

PO Box 100
Woden ACT 2602

© Commonwealth of Australia 2011

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