Document table

Regulatory

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Most recent version of the (draft) product information

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Therapeutic Goods Administration (TGA) clinical evaluator’s report

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TGA delegate’s overview

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Advisory Committee on Prescription Medicines minutes

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Australian Public Assessment Report (AusPAR)

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TGA risk management plan (including Australian-specific appendix)

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If the medicine is NOT TGA registered (see Subsection 1.3):

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• Food and Drug Administration assessment reports

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• European Medicines Agency assessment reports

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PBAC

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Full clinical study report(s) (CSR) of key evidence, including appendixes

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Trial protocol(s) and amendments (if not included in CSR)

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Publications of all relevant trials

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Statistical appendix for analyses used in the submission, including any relevant code for statistical software used in the submission

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Search strategy and literature yield from key bibliographic databases (eg an Endnote library), including reasons for exclusion of studies that meet the criteria in Subsection 2.2

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Periodic safety update report and development of the safety update report

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If an economic model is presented, provide the search strategy and literature yield related to the model structure or variables (eg an Endnote library), including a list of the sources used in the model

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Full reports of patient or clinician surveys that are used to inform the submission

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The full economic model or cost-minimisation spreadsheet

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Financial table workbook

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References (that are additional to the trial publications supplied above)

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Other

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