historical october 2010 - therapeutic goods administration · reforms (bpr). the tga has completed...

Transitional prescription medicine streamlined submission process

October 2010

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Transitional prescription medicine streamlined submission process of 34

Document Change Record

Details of Change Section Date

1 First version All February 2010

2 Review to reflect outcomes from the public and stakeholder consultation

All October 2010

3 Inclusion of current process diagrams Appendix 2 and 3 October 2010

4 Inclusion of table of submission type and scope within transition phase with reference to TGA legislative provisions.

Appendix 1 October 2010

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CONTENTS

TRANSITIONAL PRESCRIPTION MEDICINE STREAMLINED SUBMISSION PROCESS ................. 1

DOCUMENT CHANGE RECORD .......................................................................................................... 2

1 EXECUTIVE SUMMARY................................................................................................................ 5

2 BACKGROUND.............................................................................................................................. 7

3 OVERVIEW..................................................................................................................................... 8

3.1 SCOPE..................................................................................................................................... 8 3.2 ARGPM AND OTHER EXISTING DOCUMENTS .............................................................................. 8 3.3 KEY ELEMENTS OF THE NEW PROCESS....................................................................................... 8 3.4 COMMENTARY BOXES ............................................................................................................... 9 3.5 KEY CHANGES TO THE BUSINESS RULES..................................................................................... 9

4 PLANNING AND TRACKING OF SUBMISSIONS...................................................................... 11

4.1 REGISTRATION PHASES .......................................................................................................... 11 4.2 REGULATORY TIMELINES ........................................................................................................ 11 4.3 SUBMISSION PLANNING........................................................................................................... 12 4.4 SUBMISSION TRACKING........................................................................................................... 12

5 PRE-SUBMISSION PHASE ......................................................................................................... 13

5.1 OBJECTIVE............................................................................................................................. 13 5.2 KEY DATES ............................................................................................................................ 13 5.3 REQUIREMENTS AT PRE-SUBMISSION...................................................................................... 15

5.3.1 Module 2 data .................................................................................................................. 15 5.4 LODGMENT OF PRE-SUBMISSION PLANNING FORM ................................................................... 15

5.4.1 On-line Form via eBS ...................................................................................................... 15 5.4.2 Attachments ..................................................................................................................... 15

5.5 PRE-SUBMISSION PLANNING ACTIVITIES .................................................................................. 16 5.6 CHANGE OF DETAILS AFTER PRE-SUBMISSION ......................................................................... 16 5.7 PRE-SUBMISSION MEETINGS................................................................................................... 16 5.8 PRE-APPROVAL REQUIREMENTS .............................................................................................. 16

5.8.1 Certification by sponsor ................................................................................................... 17

6 SUBMISSION PHASE.................................................................................................................. 18

6.1 OBJECTIVE............................................................................................................................. 18 6.2 KEY DATES ............................................................................................................................ 18

6.2.1 Submission Date.............................................................................................................. 18 6.2.2 Missing the submission date............................................................................................ 19

6.3 SUBMISSION BY SPONSOR....................................................................................................... 19 6.3.1 Certification by sponsor ................................................................................................... 19 6.3.2 Application Fee ................................................................................................................ 19 6.3.3 Evaluation Fee................................................................................................................. 19

6.4 PROCESSING OF THE SUBMISSION........................................................................................... 19 6.4.1 Effective submissions ...................................................................................................... 19 6.4.2 TGA regulatory requirements .......................................................................................... 19 6.4.3 Submissions not accepted............................................................................................... 20

7 1ST ROUND ASSESSMENT PHASE ........................................................................................... 21

7.1 OBJECTIVE............................................................................................................................. 21 7.2 KEY DATES............................................................................................................................. 21 7.3 ASSESSMENT ......................................................................................................................... 21

7.3.1 Period for assessment ..................................................................................................... 21 7.3.2 External evaluators .......................................................................................................... 21

7.4 CONSOLIDATED SET OF SECTION 31 QUESTIONS...................................................................... 21

8 2ND ROUND ASSESSMENT PHASE........................................................................................... 23

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8.1 OBJECTIVE............................................................................................................................. 23 8.2 KEY DATES............................................................................................................................. 23 8.3 RESPONSE TO QUESTIONS ...................................................................................................... 23 8.4 ASSESSMENT OF RESPONSE ................................................................................................... 23 8.5 OPPORTUNITY TO REVIEW EVALUATION REPORTS..................................................................... 23

9 EXPERT ADVISORY REVIEW PHASE....................................................................................... 24

9.1 OBJECTIVE............................................................................................................................. 24 9.2 KEY DATES............................................................................................................................. 24 9.3 ACPM OVERVIEW .................................................................................................................. 24

10 DECISION PHASE ....................................................................................................................... 26

10.1 OBJECTIVE............................................................................................................................. 26 10.2 KEY DATES............................................................................................................................. 26 10.3 REVIEW AND DECISION............................................................................................................ 26

10.3.1 Review......................................................................................................................... 26 10.3.2 Decision for approval................................................................................................... 26 10.3.3 Decision for rejection................................................................................................... 26

11 POST-DECISION PHASE ............................................................................................................ 27

11.1 OBJECTIVE............................................................................................................................. 27 11.2 KEY DATES............................................................................................................................. 27 11.3 FINAL ADMINISTRATION ........................................................................................................... 27 11.4 PUBLISHING DOCUMENTATION ................................................................................................. 27 11.5 ARTG REGISTRATION............................................................................................................. 28 11.6 APPEAL PROVISIONS............................................................................................................... 28

12 ADMINISTRATION....................................................................................................................... 29

12.1 MILESTONE DATES.................................................................................................................. 29 12.2 WITHDRAWAL OF SUBMISSIONS ............................................................................................... 29

13 REVIEW........................................................................................................................................ 30

APPENDIX 1 - PRESCRIPTION MEDICINES – SUMMARY OF REVISED PROCESSES AND GUIDANCE ........................................................................................................................................... 31

APPENDIX 2 - STREAMLINED SUBMISSION PROCESS REGULATORY PHASES...................... 33

APPENDIX 3 - STREAMLINED SUBMISSION PROCESS PLANNING TIMELINES......................... 34

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1 Executive Summary In the modern regulatory environment health regulators around the world, such as the TGA, are being asked for greater transparency in their regulatory processes, earlier access to novel therapies and more cost effective regulatory processes. Mindful of these sometimes competing demands the TGA is implementing the prescription medicines Business Process Reforms (BPR).

The TGA has completed a review of the prescription medicine evaluation process, with a number of areas for streamlining being identified. Currently, it takes on average approximately 500 days for a new prescription medicine to be approved by the TGA. The BPR has identified a number of areas for process improvement to reduce this time significantly, to approximately 300 days. This will be achieved by eliminating unnecessary queues and delays in the evaluation process that have developed over time. It is important to note that this can be achieved without compromising the scientific rigour of the evaluation process; ensuring appropriate standards of quality, safety and effectiveness are maintained.

The key elements of this streamlined process are:

1. Clearly detailed submission and associated dossier requirements

2. Sponsor lodgement of proposed submission details (via a Pre-submission Planning Form) 2 ½ months prior to lodgement of their complete submission and associated dossier

3. TGA scheduling of resources to handle a submission it knows is coming on a certain date

4. Careful checking of the submission and associated dossier prior to commencement of evaluation to ensure compliant with application form and Common Technical Document (CTD) requirements

5. New business processes within TGA to more effectively manage workflow and queues

6. Consolidation of regulatory questions to avoid unnecessary steps in the process

7. Requirements for sponsors to answer regulatory questions in a defined timeframe to allow the new work processes to proceed without delay

8. Publication of a summary of the regulatory decisions made in relation to evaluation for new prescription medicines, or major variations to existing prescription medicines

9. Publication of Product Information and Consumer Medicines Information on the TGA website.

The streamlined process clearly articulates what is required for an effective submission, and makes clear that submissions that do not meet these requirements will be deemed not effective. At present, prescription medicine submissions are generally accepted irrespective of whether or not all necessary information is present. This has contributed significantly to the queues and delays in the evaluation process.

In addition, currently companies are asked for clarifications on evaluation matters throughout the process, requiring the evaluation to repeatedly stop and start. This, coupled with often lengthy response times to the questions of clarification, can further lengthen the evaluation completion time.

Sponsors of submissions found to be deficient at the submission phase will have their submission deemed not effective and they will not be accepted for evaluation. They will then be required to resubmit a new submission, and pay a new application fee, once they have obtained all necessary information.

This fundamental change requires the TGA to provide clear requirements for an effective submission. The current CTD requirements for quality, safety and efficacy, as adopted in

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Australia from the European Union (EU), are being supplemented with a clear list of the requirements that must be addressed in the CTD provided with the submission.

This will ensure the submission lodged with the TGA contains the information required to allow determination of the application for registration under section 23 of the Therapeutic Goods Act 1989 and reduce the incidences where the information is provided by the sponsor after the evaluation process has commenced (as is the current practice).

Once a submission has been accepted by the TGA for evaluation, the questions of clarification that arise during the evaluation process will be consolidated into one set of questions with a set time for sponsors to respond.

In principle support to this approach has been provided by industry associations and the members of an industry working group who have assisted in developing concepts and identifying issues that need to be considered. To ensure all stakeholders understand the requirements that underpin the new streamlined process and the change in existing practices required by both the TGA and prescription medicine companies, education and training activities will be implemented through road shows the requirements are being provided for discussion and comment.

The active pre-submission process in the proposed model will enable better workforce planning and foster higher quality submissions, leading to shorter overall evaluation times.

Following public and stakeholder consultation in February 2010, TGA decided to commence a 12 month transition phase from 1 November 2010. The transition phase is cognisant of the concerns raised by sponsors throughout the consultation and the significant changes in business process that are required for both sponsors and the TGA.

In embarking on this endeavour, it is recognised that the clarity of the business rules and requirements will evolve and throughout the transition phase as sponsors and the TGA work towards the success of the initiative. Communication about these changes to arrangements and performance against milestone dates and exceptions will be conducted throughout the transition.

The requirements for the transition phase for the new streamlined process are provided in the following documents available on the TGA website.

Transitional Mandatory Requirements for an effective submission as at October 2010

Prescription medicines application form; and

Transitional CTD Module 1: Administrative Information and Prescribing Information for Australia

The TGA aims to implement revised processes that meets the needs of the future health system, and is capable of being an active participant in the Government’s health reform agenda by adapting its regulatory structures and processes to meet the challenges of this changing environment.

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http://www.tga.gov.au/docs/html/pmrvform.htm

http://www.tga.gov.au/docs/html/eugctd.htm#mod1


2 Background

The TGA is progressing the prescription medicines Business Process Reforms (BPR), which when fully implemented will:

increase the transparency of the regulatory process;

provide enhanced access to prescription medicine information; and

significantly improve timelines for registration of prescription medicines.

These reforms are drawn from many previous industry consultations, including those arising out of the planning for the ANZ Therapeutic Products Authority in recent years, and also build on initiatives explored at an Access to Medicines Working Group (AMWG) workshop.

The Access to Medicines Working Group (AMWG) identified streamlining the registration process for new prescription medicines as one of three priority areas. The workshop was held in December 2007 and looked at the arrangements for processing applications to both the TGA and Pharmaceutical Benefits Advisory Committee (PBAC) and discussed potential changes to reduce the time it takes to list new medicines on the Pharmaceutical Benefits Scheme. The workshop involved representatives of the TGA, Medicines Australia and the Department of Health and Ageing.

Since April 2009, the TGA has been working with an industry working group who assisted in developing concepts and identifying issues that need to be considered. The members of the group are listed on the TGA website for the information of interested parties.

Consultation has also occurred with various industry bodies including Medicines Australia, the Generic Medicines Industry Association, AusBiotech and the Consumer Health Forum. Several documents have been released for public consultation over the 2009 calendar year.

The first components of the reforms have been implemented with improvement to the transparency of existing regulatory processes and enhanced access to information about prescription medicines. This has occurred via the:

publication of the first Australian Public Assessment Reports (AusPARs) that clearly describe the TGA's assessment of the scientific information that has allowed the TGA to make a decision about the risks and benefits of a new prescription medicine; and

successful launch of the Product Information and Consumer Medicines Information portal on the TGA website.

The business rules included in this document have been designed to reduce the time for the TGA’s regulatory processes, whilst maintaining public safety, through effective and transparent review of prescription medicine submissions.

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3 Overview 3.1 Scope The business rules, and supporting requirements for an effective submission, will apply to submissions to register a new prescription medicine or changes to an already registered medicine that involve clinical, non-clinical or bioequivalence data. These submissions are known as Category 1 and Category 2 submissions. A table detailing the submission type and the inclusion in the transition phase is provided at Attachment 1 of this document.

3.2 ARGPM and other existing documents Changes to the regulatory requirements and process as a result of the streamlined submission process are outlined in this document. The requirements outlined in the Australian Regulatory Guidelines for Prescription Medicines (ARGPM), may also apply to these submissions. Where there is an overlap in the requirements, this document should be used for guidance. The TGA will progressively update the requirements in the ARGPM.

The pre submission planning form, the prescription medicines application form, the Transitional mandatory requirements for an effective submission, the Transitional Draft Module 1: Administrative Information and Prescribing Information for Australia, and this document have been updated to reflect the requirements for an effective submission that are previously incorporated in Appendix 3 - Requirements that must be provided in an effective submission of this document.

In addition, Common Technical Document (CTD) requirements for quality, safety and efficacy, as adopted in Australia from the European Union (EU), is supplemented with a clear list of the requirements that must be addressed in the CTD provided with the submission. This will ensure the submission lodged with the TGA contains the information required to allow determination of the application for registration under section 23 of the Therapeutic Goods Act 1989 and reduce the incidences where the information is provided by the sponsor after the evaluation process has commenced (as is the current practice).

3.3 Key elements of the new process The key elements of the new streamlined process are:

1. Clearly detailed submission and associated dossier requirements to assist sponsors in lodging complete submissions ready for evaluation

2. Sponsor lodgement of proposed submission details (via a Pre-submission Planning Form) 2 ½ months prior to lodgement of their complete submission and associated dossier

3. TGA scheduling of resources to handle a submission it knows is coming on a certain date

4. Careful checking of the submission and associated dossier prior to commencement of evaluation to ensure compliant with application form and Common Technical Document (CTD) requirements

5. New business processes within TGA to more effectively manage workflow and queues

6. Consolidation of regulatory questions to avoid unnecessary steps in the process

7. Requirements for sponsors to answer regulatory questions in a defined timeframe to allow the new work processes to proceed without delay

8. Publication of a summary of the regulatory decisions made in relation to evaluation for new prescription medicines, or major variations to existing prescription medicines

9. Publication of Product Information and Consumer Medicines Information on the TGA website.

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3.4 Commentary boxes

COMMENT

There are some areas of the business rules where supporting comments are made for the benefit of clarification or to highlight additional administrative changes being considered as part of the streamlined submission process. These appear as comment boxes.

3.5 Key changes to the business rules Management by milestones. The full regulatory process for the streamlined submission process consists of seven phases with eight milestones, allowing effective planning and tracking by the TGA and sponsors. Each phase has established time periods, which will be managed by the TGA to ensure target timeframes are met and documentation is completed.

Quality of submissions. There will be a requirement for well-planned, high quality, complete submissions to be lodged by sponsors, based on clear requirements supplied by the TGA. Sponsors who submit incomplete, delayed or poor quality submissions will no longer be given opportunities during the regulatory process to address deficiencies in the data provided with the submission by providing additional or supplementary data.

Pre-submission. Sponsors will provide planning data at the pre-submission phase, in accordance with the requirements of the Pre-submission Planning Form. Planning data will include general submission information as well as information about the proposed submission type (e.g. New Chemical or Biological Entity, New Generic or Variation). Sponsors are strongly encouraged to provide details of their quality, non-clinical and clinical evidence to also assist the TGA in planning. The information will provide the TGA with the necessary level of understanding of the proposed submission to enable effective resource planning.

Sponsors should not lodge a Pre-submission Planning Form with a proposed submission date until they are confident that all necessary data for evaluation will be ready for delivery on the proposed submission date.

After the TGA has processed the Pre-submission Planning Form the TGA will send the sponsor a Planning Letter that provides key dates throughout the regulatory process.

Please note: Pre-submission meetings will continue – the Pre-Submission Phase does not replace the existing opportunity for sponsors to conduct face-to-face discussions with the TGA regarding aspects of their proposed submission. Pre-submission meetings may occur at any stage – they are not linked to activities on the regulatory process timeline.

Submission. Sponsors will provide data for evaluation at the submission phase. Sponsors must ensure submissions meet the TGA requirements for format and content, otherwise the submission will be deemed “not effective” under Section 23 of the Therapeutic Goods Act 1989 (the Act). The TGA requirements have been provided in this document for information and comment from external stakeholders. There will be no requests for information under Section 31 of the Act at the initial submission lodgment phase (as occurs now), to address submissions that do not meet the TGA requirements. A 15 calendar day period for processing of submissions will enable the TGA to complete administration and validation activities. The TGA will send the sponsor a letter advising if the submission has been:

accepted for evaluation; or

deemed not effective and therefore will not be accepted for evaluation. One consolidated set of Section 31 questions. There will no longer routinely be multiple requests for information under Section 31 of the Act. There will now be:

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one opportunity to answer specific evaluation questions during the assessment phases. The consolidated set of Section 31 questions will be sent at a pre-designated date, so that sponsors may conduct any necessary preparation activities; and

where applicable, one opportunity to provide comment (Pre-Committee response) on the Delegates Overview prior to independent review of the evaluation by the Advisory Committee on Prescription Medicines (ACPM).

COMMENT

The Australian Drug Evaluation Committee (ADEC) has been changed to the Advisory Committee on Prescription Medicines (ACPM) effective from 1 January 2010. The purpose of this name change is to emphasise the advisory role of expert committees within the regulatory framework. The Committee role does not change for the new streamlined submission process.

No additional data or supplementary data. The documentation presented at submission will be taken as the complete submission; there will be no further opportunity to deliver new data (including label mock-ups or specimens) after the submission date, with the following exceptions, where:

data applies to new safety signals (sponsors are obliged to inform the TGA as soon as new information becomes available); or

the TGA requests specific data as part of the evaluation process.

There will no longer be an opportunity for sponsors to provide Supplementary Data on receiving the Evaluation Reports.

In the interests of evaluation efficiency, the TGA will continue to contact the sponsor for clarification at any time through the process, however again this contact is not intended to request supplementary data and seeks to enable an effective evaluation within the designated timelines.

Priority evaluations. There is no longer a formal priority evaluation system.

As the streamlined submission process relies on planning resources in advance to evaluate submissions, there may be limited opportunities for conducting evaluations any faster than the standard streamlined submission process. However, if a submission is considered by the TGA to be a significant therapeutic advance, the TGA will, wherever possible, place these submissions into any gaps created by other sponsors not lodging submissions or responding to the consolidated list of questions by the required date/s. Wherever possible the TGA will work with the relevant sponsor with a view to facilitating early access to the new product, provided the product meets the TGA’s quality, safety and efficacy requirements.

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4 Planning and tracking of submissions

4.1 Registration Phases Effective planning and tracking of submissions requires regular review and management of activities throughout the regulatory process.

The regulatory process for registration of a prescription medicine will consist of eight phases in the new streamlined submission process. Each phase has a milestone that must be completed before commencement of the following phase. This approach enables effective and transparent management of work resources and timelines for all submissions. The eight phases include:

1. Pre-submission

2. Submission

3. 1st round Assessment

4. Response to consolidated S31 questions

5. 2nd round Assessment

6. Expert Advisory Review

7. Decision

8. Post-Decision

Appendix 1 provides a pictorial representation of the regulatory phases. Each of the phases is detailed in the following sections of this document, providing information on phase objectives, key dates, expected timeframes and the resulting milestone to be achieved.

Post registration onto the Australian Register of Therapeutic Goods (ARTG) activities are outside the scope of this document.

4.2 Regulatory Timelines Depending on the type of submission, different phases will be required which will affect the overall length of time to complete the submission process. For initial planning purposes, submissions are categorised into three distinct groups that cover some or all regulatory phases.

● Default plan ○ Optional Pre-

Submission Submission 1st Round

AssessmentConsolidated

S31

Response

2nd Round Assessment

Expert Advisory Review

Decision Post- Decision

New Chemical Entities, Extensions of Indications

● ● ● ● ● ● ● ●

Generic medicines, Product Information Changes, Variations to existing products

● ● ● ● ● ○ ● ●

Additional Trade Names ● ● ○ ○ ● ●

The streamlined submission process introduces planning timeframes into each of the phases, based on completion of key activities by the middle or end of a month.

The Pre-submission Planning Form is for improved planning of TGA resources, rather than for any assessment – the proposed submission cannot be accepted or rejected at the Pre-Submission phase. However, if TGA’s validation of the Pre-submission planning form indicates that the information required is absent or below the required standard, the sponsor will be advised that form is insufficient to enable the TGA to assess the depth and breadth of

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the proposed submission; and deemed to be incomplete. The sponsor will be required to resubmit the Pre-submission planning form at the next round.

While the legislated TGA commitment of 40 working days between receipt of a submission and notification of acceptance or rejection of that submission will initially remain, this process will be replaced by a period of 15 calendar days for Processing of the Submission – this forms the Submission Phase.

The legislated TGA commitment of 255 working days between acceptance for evaluation through to the Delegate decision will also initially remain but will not be used for planning or for target times. The streamlined submission process is designed to take no more than 300 calendar days (10 months), including the time for sponsor activities.

4.3 Submission Planning Due to the quantity, complexity and variety of submissions lodged for evaluation and registration with the TGA, it is essential that planning is conducted as early as possible to enable smooth progression through the regulatory process.

Submissions will not be able to be lodged to amend any details for a product until the product is on the ARTG. If a sponsor wants to make changes to a product, the submission should not be lodged until the registration process is finalised.

Planning occurs at the Pre-Submission phase through identification of the submission type, the product and the proposed submission date. The submission type enables the TGA to identify the work resources required, including the specific areas of expertise. This phase will also allow for the identification of any circumstances that may require the default timelines to be altered, with the knowledge of the sponsor, for a specific submission.

The submission date enables the TGA to allocate the resources for the planned dates for each applicable phase of the regulatory process.

As any change to the plan affects later phases, it is essential that they be made at the earliest time to avoid reallocation of resources and potential delays.

Due to the resource planning occurring two and a half months in advance, for any submission that has not arrived by the expected date, the sponsor will need to re-commence by lodging the Pre-submission Planning Form again.

Where the TGA is not able to meet a planned date the TGA will contact the sponsors to advise the sponsor of the revised dates.

4.4 Submission Tracking Once the Pre-submission Planning Form is lodged the TGA will track the submission through the regulatory process. This will provide:

a TGA single contact point for the sponsor;

improved co-ordination within the TGA across all evaluation units and evaluators associated with the submission;

administrative planning at the Pre-submission phase;

validation of the Submission at the Submission phase; and

coordination of formal correspondence between the TGA and the sponsor. Hist

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5 Pre-submission phase Milestone

TGA Planning Letter sent. Evaluators identified. 5.1 Objective M1

The Pre-Submission phase will apply to submissions to register a new prescription medicine or changes to a medicine that involve clinical, non-clinical or bioequivalence data, excluding requests for Additional Trade Names. These submissions are known as Category 1 and 2 submissions.

Key Activities

Pre-Submission Planning Form lodgement (before 1st of month)

Pre-Submission Planning

Sponsor

TGA

The Pre-Submission phase is intended to provide sufficient planning data for the TGA to organise work resources well in advance of the submission being lodged. This will enable assessment of a submission to take place with minimal delay by evaluators who are best suited to review the evidence.

A Pre-submission Planning Form may be lodged if the trade name is not known - the sponsor should use the format “company name, dosage form”. The subsequent lodgement of the submission must include the proposed trade name - if necessary submissions for additional trade names can be lodged post approval.

During the 12 month transition phase the current arrangement for fee will remain in place.

TGA is considering the option to charge fees for the lodgement of a Pre-submission Planning Form to reflect the work involved in the planning and allocation of resources that commenced at this phase.

All changes to the fee arrangements will be made in consultation with industry.

Note. Opportunity for face-to-face discussion with the TGA on aspects of a proposed product or submission remains available through Pre-Submission Meetings.

Milestone 1. A TGA Planning Letter will be sent to the sponsor, providing transparency of the milestone dates for planning and tracking purposes by both the TGA and the sponsor. All evaluator resource requirements will be allocated by the TGA.

5.2 Key Dates The Pre-Submission phase commences with the lodgement of a Pre-submission Planning Form. A Pre-submission Planning Form should be lodged at least 2 ½ months prior to the intended lodgement date for the submission.

The TGA will process all the Pre-submission Planning Forms received on or before the day preceding the 1st day of each month. A Pre-submission Planning Form lodged on the 1st day of a month will wait until the next month to be processed.

Within six weeks of receipt of a Pre-submission Planning Form, the TGA will send the sponsor a TGA Planning Letter that provides the expected submission date, based on the sponsor’s proposed date, and dates for key milestones, such as release of the consolidated set of Section 31 questions, release of the Evaluation Reports and the Initial Decision.

For large submissions (greater than 200 volumes in total), the TGA may require additional time for initial receipt, records management requirements and validation processes. The sponsor will be advised in the TGA Planning Letter whether an earlier delivery date is requested.

An example of a planned timeline is provided in the table below.

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Activity Date

Pre-submission Phase

Sponsor submits Pre-submission Planning Form

25 July 10

TGA commences processing Pre-submission Planning Form

3 August 10

TGA Planning Letter sent to sponsor By 14 September 10

Submission Phase

After receipt of the TGA Planning Letter, lodgement of Submission and supporting data

Before 15 October 10

1st Round Assessment Phase

Commencement of evaluation 2 November 10

Consolidated Set of Section 31 Questions sent from TGA to sponsor

By end February 11

Coordinated S31 question response by sponsor

30 day option – selected at PPF By end March 11

60 day option – selected at PPF By end of April 11

2nd Round Assessment Phase

Response from Sponsor to TGA By end March 11

Evaluation Reports sent to sponsor By end April 11

Expert Advisory Review Phase

Request for ACPM Advice (Delegate’s overview)

3 May 11

Planned ACPM meeting 3 June 11

Decision Phase

Decision Date 3 July 11

Planned evaluation time is 8 months

Post-Decision Phase

Draft AusPAR sent to sponsor 17 July 11

ARTG Entry created, documents published (Final AusPAR, sponsor-uploaded PI and CMI)

9 August 11

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5.3 Requirements at Pre-Submission The information submitted with the Pre-submission Planning Form must include administrative details along with sufficient data for the TGA to understand the complexity, scope and scale of the proposed submission.

5.3.1 Module 2 data

TGA encourages the lodgement of a complete Module 2 with the Pre-submission Planning Form. Module 2 data is the summary section of the Common Technical Document (CTD), with the CTD being the only format the TGA accepts evidence to support applications to register prescription medicines. This will enable the TGA to plan more effectively for the complexity of the proposed submission.

Where a complete Module 2 dataset is not available, the subset of the Module 2 data or equivalent must be provided as a minimum.

An “equivalent” document is one that:

• May be in either draft or final version, and • Contains all of the information specified in the relevant subsection of Module 2,

but • Does not need to be in the format or structure specified by the relevant subsection

of Module 2. For example, a sponsor’s internal document used for the initial consideration of the viability of a new chemical entity product that provides all of the information required by subsections 2.3.S, 2.3.P, 2.4, 2.6.2, 2.6.4, 2.6.6, 2.5, 2.7.1, 2.7.2, 2.7.3 and 2.7.4 but is presented in a different structure would be acceptable to attach to the pre-submission planning form.

These requirements are set out in the Pre-submission Planning Form and the Information for sponsors completing a pre-submission planning form document.

5.4 Lodgment of Pre-submission Planning Form 5.4.1 On-line Form via eBS

The Pre-submission Planning Form is accessed via the TGA website. It is completed, saved and then lodged as an attachment via eBS.

The Form is currently accessed via the TGA website Once integrated as an online smart form into eBS, sponsor information will be automatically retrieved and entered onto the form.

The form requests information about the sponsor, product and submission. This information is intended to provide sufficient planning data for various administrative and evaluation units throughout the TGA.

The planning data provided at pre-submission, along with the application form and evaluation data provided at submission, comprise the complete information required under Section 23 of the Act to allow determination of the submission.

The Pre-submission Planning Form must be completed for all sections appropriate to the proposed submission. Where the form is not complete, the TGA is unable to proceed with planning activities and will not be able to commence resource planning requirements. If this occurs the TGA will notify the sponsor and a new Pre-submission Planning Form will need to be completed and lodged at the next round.

5.4.2 Attachments

The data provided with the Pre-submission Planning Form must be lodged electronically via eBS with the form. This data is vital for understanding the complexity of the proposed

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submission and for ensuring evaluators best suited to the submission are identified and organised.

The Pre-submission Planning Form provides details of the data that is to be supplied as attachments.

5.5 Pre-Submission Planning Activities The TGA will review Pre-submission Planning Forms lodged prior to the 1st of each month.

The TGA will use the information to plan resource availability, including external evaluators, where necessary.

The data supplied will enable the TGA to estimate the complexity and scope and scale of the proposed submission and to ensure that the proposed submission type is correct. It will also highlight any areas of risk to the schedule, that required alignment such as delays to GMP clearances.

5.6 Change of details after Pre-Submission Any change that increases the content or complexity of a submission that occurs after lodging the Pre-submission Planning Form will not be accepted – a new Pre-submission Planning Form must be lodged with new submission dates.

Examples of changes deemed not acceptable include:

Significant change of proposed indication or addition of an indication

Increase to the number of studies that form key sources of evidence (including, but not limited to Pivotal Phase III studies, Biopharmaceutic Studies, Carcinogenicity Studies).

5.7 Pre-Submission Meetings Sponsors may wish to discuss scientific or procedural issues with the TGA prior to lodging the submission. This option is independent from lodgement of the Pre-submission Planning Form and may occur well in advance of the lodgement process.

A pre-submission meeting between TGA staff and sponsors should occur well in advance of Pre-submission Planning Form lodgement to take advantage of any advice or feedback from the TGA in preparation for the Pre-Submission phase. The TGA strongly recommends that sponsors organise a pre-submission meeting for complex submissions, especially if there is a need for either party to provide clarity on a particular issue or there is some uncertainty as to whether the proposed submission will meet all Australian regulatory requirements.

5.8 Pre-approval requirements

Some submissions require approval from the TGA prior to the sponsor lodging the Pre-submission Planning Form. These are as follows:

Orphan drug applications. To register a medicine under the Orphan Drug Program, a sponsor must first request and be granted orphan drug designation by the TGA. Therefore, discussion with the TGA regarding orphan drug applications should commence well before the pre-submission phase. If a sponsor has applied/intends to apply for orphan drug designation and has not received approval for the designation at the time they plan to lodge their submission, any relevant fees must be paid at the time of lodgement.

Literature based submissions. Agreement on the search strategy and the databases to be searched is required prior to lodgement of the Pre-submission Planning Form. This is because the data provided with the submission is dependent on the search strategy. Sponsors should plan to discuss issues with the TGA at least three months prior to the pre-submission phase.

Fixed Combination Submissions. For a new fixed combination product the sponsor must justify the particular combination and the type and extent of data to be submitted

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prior to lodging a Pre-submission Planning Form. This should be done by correspondence that addresses the adopted EU guideline document.

Some submissions require evidence that the approval process has commenced prior to the lodging the Pre-submission Planning Form. These are as follows:

Ingredients. New non proprietary or proprietary ingredients will require that a notification of a proprietary ingredient for each new proprietary ingredient OR a form for proposing a new chemical name (AAN), biological name (ABN) and/or herbal name (AHN) for each new non-proprietary ingredient. (Note that unless justified, additional toxicology data will need to be provided to the TGA to support the safety of an existing ingredient that is to be used for different purposes to that originally approved e.g. new dosage form, new route of administration.)

Genetically Modified Organisms. A copy of any OGTR licence, acknowledgment of receipt or tother record of consent from the OGTR; or alternatively, a declaration of exception.

From 1 July 2010, the TGA has increased responsibilities for regulating the scheduling of medicines. The Pre-submission Planning Form will request information from the sponsor about the scheduling of their proposed submission, with the aim of ensuring alignment of the scheduling and evaluation activities.

5.8.1 Certification by sponsor

The sponsor will be required to declare on the Pre-submission Planning Formthat they understand the TGA’s requirements for an effective submission.

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6 Submission phase TGA Notice of Acceptance sent.

Milestone

6.1 Objective M2

The Submission phase covers processing activities in preparation for commencement of assessment. For the TGA, processing activities include:

Key Activities

Submission and fees submitted to TGA (Before 15th of month)

Processing of Submission

Sponsor

TGA

receipt and delivery arrangements of the submission and supporting data;

receipt of fees;

workflow and IT administration; and

validation of the submission against the TGA regulatory requirements.

Milestone 2. The TGA will send a letter to the sponsor, identifying whether the submission is accepted for evaluation.

6.2 Key Dates The Submission phase commences with receipt of the submission and supporting data.

Submissions must be received by the date specified in the TGA Planning Letter.

The TGA will complete the Submission phase by the last day of the month.

A letter will be sent to the sponsor by the last day of the month.

6.2.1 Submission Date

Once the Pre-submission Planning Form has been processed, the TGA will issue a Planning Letter to the sponsor that outlines the key dates for each phase of that submission, including the expected date of lodgement for the submission.

The submission can be lodged anytime between the receipt of the Planning Letter and Close of Business on the expected date of lodgement identified in the letter. However, it should be noted that the TGA will not commence processing the submission until the day after the expected date of lodgement.

Lodging the submission involves providing the TGA with electronic and hard copies of:

the Application for the Registration, or to vary the Conditions of Registration, of Prescription Medicines; and

all the supporting data for the submission.

In most cases, the expected date of lodgement is calculated by taking the 15th day of the month, two months following the lodgement of the Pre-submission Planning Form. Some large submissions (in excess of 200 D-ring binders) may be required to be lodged up to one week earlier, in order to allow additional time for processing and for availability of warehouse capacity. Sponsors will be informed in the TGA Planning Letter if this is required.

For example, if a Pre-submission Planning Form is lodged on 26 May 2010, the TGA will commence processing the form on 1 June. The sponsor will receive the TGA Planning Letter by 15 July, and they can lodge the submission once they have received this letter. However, the Application Form and supporting data must be received at the TGA by COB on 13 August 2010 (as 14 August 2010 is a Saturday).

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6.2.2 Missing the submission date

As the TGA handles multiple submissions each month, there will be no time set aside to follow-up individual submissions that do not arrive on time. The TGA will need to re-allocate the evaluation resources that have been allocated to conduct the evaluation for the submission that has not been lodged.

Due to the resource planning occurring two and half months in advance, for any submission that has not arrived by the due date, the sponsor will need to lodge the Pre-submission Planning Form again.

6.3 Submission by sponsor 6.3.1 Certification by sponsor

The sponsor will be required to certify on the Prescription Medicines Registration Form that the data delivered at the time of submission constitutes the entire evidence presented by them for evaluation.

There will be:

no delivery of Additional Data after submission; and

no opportunity to submit Supplementary Data.

The only data that may be sent by the sponsor without prior request or invitation from the TGA will be for safety-related issues that may affect the outcome of a submission, where sponsors are obligated to inform the TGA as soon as they become aware of the safety issue.

6.3.2 Application Fee

The Application fee is a proportion of the evaluation fee that is non-reimbursable from the time of submission. Where submissions are not accepted due to deficiencies in the submission this amount will be retained by the TGA, covering administrative costs associated with the Submission phase.

The Application Fee is described in the Regulations, as 20% of the Evaluation fee up to a maximum amount. The maximum amount is presently $7,600 and is indicated on the TGA website within the current fees for 2009/10.

6.3.3 Evaluation Fee

For Category 1 and 2 submissions, payment of 100% of the evaluation fee is requested when the submission is lodged.

6.4 Processing of the Submission 6.4.1 Effective submissions

Submissions will be accepted for evaluation provided that:

the submission follows the lodgement of a Pre-submission Planning Form;

a Prescription Medicines Registration Form approved by the TGA, including certification that all data for consideration by the TGA has been presented at the time of submission;

the submission is in accordance with the TGA regulatory requirements; and

appropriate fees have been paid. The Application Form and a copy of the sponsor’s application letter should be sent to the Financial Services Group (FSG) of the TGA with the appropriate fee payable in accordance with Schedule 9 of the Regulations.

6.4.2 TGA regulatory requirements

Sponsors must abide by all applicable regulatory requirements. These requirements include those set out in:

Therapeutic Goods Act 1989

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http://www.tga.gov.au/legis/index.htm


Therapeutic Goods Regulations 1990

all relevant:

Therapeutic Goods Orders

ICH and CHMP guidelines that have been adopted by the TGA

Australian Regulatory Guidelines for Prescription Medicines (ARGPM)

Transitional CTD Module 1 – Administrative Information and Prescribing Information for Australia, and

EU Common Technical Document (CTD) format documents adopted by Australia.

The current CTD requirements for quality, safety and efficacy, as adopted in Australia from the European Union (EU), are being supplemented with a clear list of the requirements that must be addressed in the CTD provided with the submission.

This will ensure the submission lodged with the TGA contains the information required to allow determination of the application for registration under section 23 of the Therapeutic Goods Act 1989 and reduce the incidences where the information is provided by the sponsor after the evaluation process has commenced (as is the current practice).

The requirements for the transition phase for the new streamlined process are provided in the following documents available on the TGA website.

Transitional Mandatory Requirements for an effective submission as at October 2010

Prescription medicines application form; and

Transitional CTD Module 1: Administrative Information and Prescribing Information for Australia

.

6.4.3 Submissions not accepted

Submissions that do not meet the TGA’s regulatory requirements will not be accepted in accordance with section 23 of the Act. The submission will not be returned to the sponsor as once it is received by the TGA it becomes a Commonwealth record. The Application Fee will not be reimbursed.

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http://www.tga.gov.au/docs/html/euguidead.htm

http://www.tga.gov.au/pmeds/argpm.htm

http://www.tga.gov.au/docs/html/eugctd.htm

http://www.tga.gov.au/docs/html/eugctd.htm

http://www.tga.gov.au/docs/html/pmrvform.htm

http://www.tga.gov.au/docs/html/eugctd.htm#mod1


7 1st round assessment phase Assessment done, or consolidated set of s.31 questions sent.

Milestone

Key Activities

Assessment by Primary and Secondary Evaluation Units

7.1 Objective The 1st Round Assessment will consider all the supporting data provided with the submission. Where there are issues or questions about any component of the submission a consolidated set of Section 31 questions from all evaluation areas within the TGA will be developed and sent to the sponsor by a pre-determined date.

Sponsor

TGA

Within this assessment phase TGA evaluators may directly contact the sponsor to seek clarification or ask questions informally if they determine waiting for the formal consolidated set of Section 31 questions on a minor clarification is unnecessary. This type of informal question will not change the timeline for the consolidated set of Section 31 questions.

Consolidated set of s.31 questions compiled

Milestone 3. A consolidated set of Section 31 questions is sent to the sponsor.

7.2 Key dates The 1st Round Assessment phase commences after a letter has been sent, advising the sponsor that their submission has been accepted for evaluation.

Initial assessment of all evidence will generally take three months to complete.

A consolidated set of Section 31 questions will be compiled, checked and authorised within 30 days of completion of the initial assessment period.

The additional month, over and above the three month 1st round assessment phase, has been included into the new process to ensure that issues and concerns from all evaluation areas are clearly identified and consolidated into the questions.

7.3 Assessment 7.3.1 Period for assessment

The default period of 1st Round Assessment is 90 days for completion, with an additional 30 days for the preparation of the consolidated set of Section 31 questions. Occasionally, highly complex submissions may require greater than 90 days for evaluation. In these situations, a recommended increase to a Milestone must be authorised internally within the TGA and the sponsor informed of the situation.

7.3.2 External evaluators

The TGA may contract external evaluators to review aspects of the data. The TGA will coordinate the evaluation with the external evaluator, as part of the 1st Round Assessment phase. Communication with the sponsor in relation to an evaluation will be through the TGA.

7.4 Consolidated set of Section 31 questions At the end of the 90 day 1st round assessment, any issues or questions from evaluation units will be consolidated into one document. The TGA may request further data or clarification to existing evidence.

The consolidated set of Section 31 questions will be compiled, checked and authorised before they are sent to the sponsor. The sponsor will then have 30 days in which to address

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the questions and submit a response prepared in CTD format that will allow distribution of the response to the relevant evaluation areas within the TGA.

Milestone 4. Sponsor response to consolidated set of Section 31 questions within their 30 or 60 day timeframe as designated at the pre submission phase.

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Milestones

8 2nd round assessment phase M4 Sponsor response received Evaluation Reports sent to Sponsor

Key Activities

Assessment of response and final report completed

Response to TGA Questions compiled

M5

8.1 Objective Sponsor The 2nd Round Assessment will deal with any areas of evaluation

that require further clarification of data in order to complete outstanding sections of evaluation reports.

TGA

Milestone 5. All Evaluation Reports will be sent to the sponsor.

8.2 Key dates The 2nd Round Assessment phase will commence once the responses to the consolidated set of Section 31 questions are received by the TGA.

Response received at TGA

Opportunity to review Evaluation Reports

The TGA will have 30 days to complete the evaluation reports.

Evaluation reports will be sent to sponsors by the end of the month. While this defines the milestone point, there will be a short period of time for the sponsor to review factual accuracy of the evaluation reports – no more than 14 calendar days.

8.3 Response to questions As the consolidated set of Section 31 questions will be sent at a pre-determined time, sponsors should be prepared for immediate action to address issues. The pre-submission planning, including clear identification of milestone dates to the sponsor, and therefore the known date for the sponsor to receive the consolidated set of Section 31 questions, is a key change in the new streamlined submission process. This information will provide the sponsor with advanced notice of the 30 or 60 day response period. These changes, coupled with the requirement to lodge all the supporting data with the submission are critical factors that support the 30 or 60 day time period. Should the sponsor not reply in this time period the evaluation will be conducted on the information available to the TGA. Responses must be provided in electronic text PDF format (not scanned). Sponsors should also submit a hard copy of their response.

8.4 Assessment of response 2nd Round Assessment will only address issues or questions raised in the consolidated set of Section 31 questions. Where answers to questions are inadequate, or raise further questions, evaluators may liaise directly with sponsors for clarification, but no additional time will be added and no additional questions will be formally sent. Instead, outstanding issues will be highlighted in the evaluation reports. These may be significant enough to warrant a recommendation of rejection or they may be minor leading to conditions of registration that must be complied with.

8.5 Opportunity to review evaluation reports Sponsors will be given a short period of up to 14 days after receipt of the final evaluation report in which to review and advise the TGA of any perceived errors of fact or major omissions. Sponsors should also use this period to amend the proposed PI based on recommendations in the evaluation reports.

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9 Expert advisory review phase ACOPM Resolution completed.

Milestone

Key Activities

Pre-ACPM Response

Delegate’s Request for ACPM Advice

ACPM Papers circulated

ACOPM meeting

ACPM Resolution prepared

M69.1 Objective The Expert Advisory Review phase is an opportunity for the delegate to seek independent advice on issues of importance concerning the submission, including proposed recommendations for approval or rejection.

Sponsor

TGA

The main advisory group for prescription medicines is the Advisory Committee on Prescription Medicines (ACPM).

Where a delegate seeks advice from a committee other than ACPM, the business rules will equally apply to that committee for this phase. Refer to the TGA website for current function, format and documentation related to each of the advisory committees.

Milestone 6. Resolutions from the ACPM meeting are sent to the sponsor.

9.2 Key dates The planning date for this phase is the ACPM meeting. Current meetings are held on the first Friday of every second month – the February sitting is the initial meeting of each year. Options for increased frequency of meetings are being explored.

The Delegate will consider any outstanding issues and may seek clarification when writing the Request for ACPM Advice letter. This is the Delegate’s letter prepared for the Advisory Committee on Prescription Medicines (ACPM) where the delegate seeks independent advice on aspects of a submission. This letter is made available to the sponsor prior to the ACPM meeting planned to discuss the submission.The delegate’s Request for ACPM Advice must be completed and sent at least one month prior to the proposed meeting, in order for ACPM members to review the submission documentation and for the sponsor to prepare and submit a Pre-ACPM Response.

Key documentation submission times are posted on the TGA website for each ACPM meeting.

The ACPM Resolution is completed within one week after the meeting.

9.3 ACPM Overview The Delegate is not obliged to refer submissions to an expert advisory committee but generally does so for major submissions.

Generally, positive recommendations for New Generic submissions or Changes to PI will not be referred for expert advisory review.

The TGA Delegate will review the evaluation reports and if required, prepare a Request for ACPM Advice. A copy of the request is sent to the sponsor.

The letter will present an overview of the submission with key findings and outstanding issues. The letter will usually weigh risks and benefits applicable to the submission and the proposed product. The balance will enable a preliminary opinion of whether the submission should be accepted or rejected. Advice will be requested on any aspect of the submission characteristics, findings or risk/benefit considerations.

The Pre-ACPM Response is the sponsor’s opportunity to provide final comment on the submission, based on the consolidated set of Section 31 questions, the final evaluation

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reports and the Delegate’s Request for ACPM Advice. Clarification of outstanding issues should clearly be addressed at this opportunity. More information on Pre-ACPM responses is available on the TGA website – www.tga.gov.au.

Where the Pre-ACPM Response is not available for dissemination to ACPM members at least two weeks prior to the agreed meeting date, it will not be tabled for consideration by ACPM, but will be considered in the decision phase by the TGA Delegate.

The ACPM resolutions will be sent to the sponsor within 1 week after the ACPM meeting. Ratified minutes of the ACPM meeting at which a resolution is made will only be available after the following ACPM meeting. ACPM does not make decisions and its recommendations do not constitute directions to the Secretary or the Secretary’s Delegate.

ACPM recommendations are published in the Commonwealth of Australia Gazette and are listed on the TGA website. As permitted under Section 61(4) of the Act, the ACPM minutes are also provided to a number of other regulatory agencies overseas.

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10 Decision phase 10.1 Objective The TGA Delegate will decide whether the submission is to be approved or rejected. Where any outstanding issues may affect the decision, the Delegate may liaise directly with the sponsor during this phase before finalising their decision.

Initial Decision made.

Milestone

Key Activities

Delegate’s review and decision

M7

Sponsor The sponsor will be notified of the decision within 28 days (in accordance with the Act). The decision is known as the Initial Decision and will end the legislated period for evaluation.

TGA

Milestone 7. An Initial Decision has been made for approval or rejection of the submission for a new registration or for a variation to registration.

10.2 Key dates The decision phase should be completed without delay after any preceding phase, but should be completed within the month of the associated ACPM meeting or within a month after completion of the Evaluation Reports.

10.3 Review and decision 10.3.1 Review

The Delegate will review all documentation associated with the submission and will make an assessment of the risks and benefits. As part of the review, there may be a number of outstanding issues. These may relate to suggestions for revision of the Product Information (PI), Consumer Medicine Information (CMI) or Risk Management Plan (RMP), or may be for general registration details. The Delegate may negotiate these issues with the sponsor prior to making a decision.

10.3.2 Decision for approval

Where the Delegate is satisfied that benefits sufficiently outweigh risks, the Initial Decision will be for approval of a new registration, or approval to vary a registration. There may be conditions of registration associated with the approval, covering any outstanding issues from the evaluation. These may include the conduct of post-market activities by the sponsor or revision of existing documentation.

The Delegate may informally notify the sponsor immediately after the decision. The Delegate must notify the sponsor in writing of their decision within 28 days of making the decision.

10.3.3 Decision for rejection

If a Delegate proposes to reject a submission, the reasons for the decision must be included in the formal Letter of Decision to the sponsor, which is completed as part of post-decision activities. In addition to the reasons for the decision, the letter will set out the appeal rights. A formal statement of reasons may be requested from a Delegate. In cases where an ACPM recommendation to reject a submission is unexpected, for example, contrary to the Delegate’s pre-ACPM intentions, the Delegate will usually contact the sponsor to discuss the proposed actions.

A sponsor may appeal the decision of a Delegate.

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11 Post-decision phase Milestone

11.1 Objective Final payment received. M8 Documents published.

The post-decision phase will finalise administrative issues for the submission, leading to the publishing of documentation and a new or varied entry made to the ARTG.

Product registered.

Key Activities Sponsor

TGA This phase also involves activities associated with an Appeal, which may directly affect a submission’s Initial Decision.

Sponsor Appeal

AusPAR C-I-C redaction

AusPAR prepared

Documents published on website

Final Administration Milestone 8. Any outstanding evaluation payments are finalised (if applicable), relevant documents are published on the TGA website and a new or varied entry is made to the ARTG.

11.2 Key dates When a decision is made, the post-decision phase should be completed no later than the end of the following month.

This date may be affected when an appeal is lodged, in which case Milestone 8 will be delayed until all appeal activities are complete.

AusPAR prepared 11.3 Final administration All applicable documentation associated with the submission will be placed on file and all prescription medicine information systems will be updated with new or revised data. This will include future notification to the sponsor for specific conditions of registration, including for example periodic safety update reports (PSURs).

M8

Correspondence, including the formal Letter of Decision to the sponsor, will be produced and sent.

11.4 Publishing documentation Medicines information about the product and the decision process will be made available to the public via the TGA website. This information will be published as:

Australian Public Assessment Report (AusPAR)

Product Information (PI)

Consumer Medicines Information (CMI)

An AusPAR provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application. Once the AusPAR is drafted in the post-decision phase it is sent to the sponsor for review prior to it being published. Details of the contents, rules and activities associated with an AusPAR are provided in a separate guidance document, accessible on the TGA website, found at http://www.tga.gov.au/pmeds/auspar-guidance.pdf.

Product Information (PI) document(s) approved by the TGA must be lodged by the sponsor with the TGA within 2 weeks of the date of registration of the product/s. The related Consumer Medicine Information (CMI) document(s) must be lodged with the TGA:

for new product/s - prior to supply of the product/s;

for variations to existing products - within 2 weeks of the date of approval of the variation.

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11.5 ARTG registration A new or varied entry on the ARTG will be completed, as long as the decision is to register the product and applicable submissions have provided a patent certificate or notice (under 26B(1) of the Act).

The TGA will check that the provisional ARTG Record provided by the sponsor at submission matches the approved product details.

The sponsor should notify the TGA of the actual date of commencement of marketing. The provisional ARTG record will have already been checked during the quality evaluation process and will become the ARTG Record of Registration.

The Post-Decision Phase timeframe cannot be met unless the 26B Certificate required in relation to patents is provided by the sponsor.

11.6 Appeal provisions The Act provides a comprehensive system for review of administrative decisions.

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12 Administration 12.1 Milestone dates Milestone Dates for submissions are targets to be achieved by the TGA and sponsors. These are set at the first phase of a submission’s regulatory process. Any changes to a milestone date must therefore be reviewed and discussed between both parties.

Only certain designated senior TGA Officers will be able to authorise extensions to Milestone Dates.

Changes may be proposed and discussed at periodical TGA planning meetings or at out-of-session meetings. Agreed changes will be entered into the TGA management system by close of business on the day after the decision has been made.

12.2 Withdrawal of submissions A sponsor may withdraw a submission at any time following lodgement up until the Delegate’s decision on the submission is made.

The sponsor should inform the TGA in writing that they want to withdraw the submission. The TGA may publish advice that the submission has been withdrawn as per the publishing details provided in the TGA Australian Public Assessment Report (AusPAR) for Prescription Medicines document published on the TGA website at http://www.tga.gov.au/pmeds/pmbpi-transparency.htm.

Where a submission is withdrawn due to safety concerns the sponsor may be asked to provide any adverse safety data in its possession to the TGA.

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13 Review Throughout the transition phase, the TGA will work to continually improve the clarity of requirements as defined in the guidance documents and to adjust business rules, as required. Adjustments will be consulted with industry and communicated directly within the sponsor networks.

The TGA will establish a review framework, in consultation with industry. Throughout the transition period the TGA will capture performance information across each of the milestone dates and exception reporting from the perspective of both the TGA and sponsor activities. Key areas of interest include additional or supplementary data, the adequacy of information in the pre-submission phase to support effective resource planning and feasibility of consolidated list of questions.

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Appendix 1 - Prescription Medicines – Summary of revised processes and guidance

Transitional arrangements from 1 November 2010 Category Description of category

Processes Guidance documents

Category 3 Requests for variations under s.9D(3) of the Act to which Regulation 16F applies

OR

Applications for new Register entries made under s.23 of the Act to which Regulation 16G applies.

Processes for preparing and lodging submission remain unchanged.

For Category 3 submissions lodged on or after 1 November 2010, refer to the revised CTD Module 11 - as at September 2010 document.

Once released, the updated version of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) will contain further information relating to Category 3 submissions.

Category 2 Applications for new Register entries made under s.23 of the Act to which Regulation 16C(4) applies

OR

Requests for variations under s.9D(3) of the Act to which Regulation 16D(4) applies

All Category 2 submissions lodged with the TGA from 1 November 2010 will be processed through the streamlined submission process (i.e. a Pre-submission Planning Form (PPF) is required to be lodged with the TGA between 6 to 2 ½ months before the submission).

For Category 2 submissions lodged from 1 November 2010, refer to the revised CTD Module 11 - as at September 2010 document.

Once released, the updated version of the ARGPM will contain further information relating to Category 2 submissions, including details of the impact of the streamlined submission process. In the interim, further details about the streamlined submission processes can be found in the TGA’s Consultation Paper on the Requirements for the Prescription Medicine Streamlined Submission Process, available on the TGA website.

Category 1 applications solely for Additional Trade Names (ATN)

Applications for new Register entries made under s.23 of the Act where the sponsor seeks only to register an ATN for an existing registration.

Processes for preparing and lodging submission remain unchanged.

For submissions lodged from 1 November 2010, refer to the revised CTD Module 11 - as at September 2010 document.

Once released, the updated version of ARGPM will contain further information relating to ATN submissions.

Category 1 (other than submissions solely for Additional Trade Names)

All other submissions that are either:

applications for new Register entries made under s.23 of the Act to which Regulation 16C

All Category 1 submissions, with the exception of ATN applications, lodged with the TGA from 1 November 2010 will be processed


Once released, the updated version of the ARGPM will contain further information

1 The November 2008 version of CTD Module 1 requirements will remain available on the TGA website until the updated Australian Regulatory Guidelines for Prescription Medicines is released. This is due to some overlaps of information between the documents.

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http://www.tga.gov.au/pmeds/consult/cons-pmssp.pdf


Transitional arrangements from 1 November 2010 Category Description of category

Processes Guidance documents

applies

OR

requests for variations under s9D(3) of the Act to which Regulation 16D applies.

through the streamlined submission process (i.e. a Pre-submission Planning Form (PPF) is required to be lodged with the TGA between 6 to 2 ½ months before the submission).

relating to Category 1 submissions. In the interim, further details about the streamlined submission processes can be found in the TGA’s Consultation Paper on the Requirements for the Prescription Medicine Streamlined Submission Process.

Notifications Notifications (“requests”) lodged under one of the following:

s.9D(1) of the Act i.e. requests for corrections to ARTG entries

s.9D(2) of the Act i.e. “Safety Related” Notifications

s.9D(3) of the Act for “Self Assessable” Notifications as described in Part B of Appendix 12 and Appendix 13 of the ARGPM

s.9D(3) of the Act for “Minor Editorial Changes” as described in the ARGPM.

Processes for preparing and lodging remains unchanged.


Once released, the updated version of the ARGPM will contain further information relating to notifications.

Non-assessable changes

Non-assessable changes as described in Part A of Appendix 12 of the ARGPM.

Unchanged. Once released, the updated version of the ARGPM will be the applicable guidance document for such changes. In the interim, the current version of the ARGPM should be used.

Section 14 Exemption

Request for exemption from compliance with standards under s.14 of the Act.

Processes for preparing and lodging remains unchanged.

For requests lodged from 1 November 2010, refer to the revised CTD Module 11 - as at September 2010 document.

Once released, the updated version of the ARGPM will contain further information relating to Section 14 Exemptions.

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Appendix 2 - Streamlined Submission Process Regulatory Phases

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Appendix 3 - Streamlined Submission Process Planning Timelines

Sponsor activities

consolidated set of s.31 questions

1st round assessments

pre-submission review

TGA activities

Pre-submission Planning Form lodged before 1st of month

Submission lodged before 15th of month

validation of submission

2nd round assessments

delegate overview

evaluation report

reviews

response to questions

committee papers

circulated

Pre-committee response

advisory committee meeting

delegate decision

New or revising ARTG created; Website updated

AusPAR C-I-C content review

Milestones

2nd Round Assessment

Submission 1st Round Assessment

Expert Advisory Review

Decision Post-decision

M1 Re

M3 M6 M7 M8 gulatory Phases and Milestones

32 1 4

M4

5 6 7

-3 -2 -1 2 30 1 104 5 6 7 8 9 11

calendar months

M2

Pre-submission

M5

M1

M2

M3

M4

M5

M6

M7

M8

Planning Letter sent; evaluators identified

Notice of Acceptance sent

Assessment done; or consolidated set of s.31 questions sent

Sponsor response to questions received

Evaluation reports sent to sponsor

Expert advisory committee resolution complete

Initial Decision made

Documents published; ARTG entry complete; outstanding payments received (if applicable) Hist

oric

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ocum

ent