This content is current only at the time of printing. This document was printed on 12 September 2020. A current copy is located at http://www.xlg888.com/node/18821
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Getting the most out of pre-application assistance
The more specific the information you provide, the more tailored the advice the APVMA can give you.
Submit information which supports your application
For tier one assistance:
1. General guidance on the types of regulatory assessments likely to be needed for a particular application as it relates to the item, module levels, timeframes and fees for an assessment
Outline what item, modules, timeframes and/or fees you propose as appropriate for your application.
It is useful to provide the rationale which supports your proposed determinations and to reference the APVMA guidance material you used.
2. Advice on the relevance of the efficacy criteria to a proposed product/permit
Outline and describe how you consider the proposal satisfies the efficacy relevance criteria or in which area you are seeking assistance in determining relevance.
3.?Technical clarification of guidance documents on our website
Specify which guidance materials you are seeking to clarify and where possible provide links to our guidance material and quote specific sections from those documents.
For tier two assistance:
1. Types of supporting information and data that may be appropriate in a particular application
Describe the types of supporting information you propose to submit with the application and reference the APVMA guidance you used.
2.?Assistance in determining the types of trials that may be undertaken, including specific guidelines that could be considered in generating data
Detail the types of trials and/or studies you are considering conducting and submitting which may encompass numbers of trials, locations, industry standard products for bioequivalence purposes, and reporting details. Where relevant reference the APVMA guidelines and identify areas for clarification.
3. Assistance determining whether overseas data and/or assessment reports can be considered relevant or suitable
Detail the international information you proposed to submit to support your application. Where relevant advise if this information will be supplemented with bridging studies from Australian trials or if it will be stand-alone (ie no local studies).
Describe why you propose international data and/or studies should be considered relevant and outline in detail the number, content and scope of those studies both overseas and/or local.
Where overseas assessments have been completed please outline from the countries where these assessments have been conducted and whether reports from other regulators will be provided. Where relevant please refer to the APVMA guidelines and how the data/studies proposed to be submitted addresses those guidelines.
4. Advice on a scientific matter or specific aspect of the conduct and design of a study or trial
Detail the scientific matter or aspect of the conduct and design of a study or trial. Where relevant please reference the APVMA guidelines you used and quote the relevant parts.
5. Assistance on how to develop an agreed project plan for a timeshift application (including global joint review applications)
Outline/describe the proposed timeshift application by detailing which components of the application will be submitted upfront and which components will be submitted at a later date. Please include expected submission dates for all components.
For tier three assistance:
1. Appraisal of a trial protocol before commencement of studies
Include a full copy of the proposed trial and/or study protocol for appraisal. Where proposed studies are to be conducted to APVMA guidelines, please quote the guidelines being used.
If you are seeking assistance on particular areas of the study design please highlight these in your application.
2.?Assistance with a proposed new methodology or variations to an existing guideline in generating data to support an application
Detail what new methodologies or variations to existing guidelines you are proposing.
Where relevant quote the APVMA guidelines and highlight areas where you are seeking to deviate from these guidelines.
Include an explanation of why the deviations can be considered relevant, and where new methodologies are proposed, include a rationale as to why or how those methodologies can generate data appropriate for regulatory risk assessment.
3. Finalisation of a project plan for a Global Joint Review
Provide the draft project plan seeking agreement with your application.