Document table

Page last updated: September 2016

Include the following document table at the beginning of each submission. The document table may act as a checklist for sponsors, and will enable the PBAC, subcommittees and evaluators to quickly identify unavailable documents.

Document table

Document requesteda

Reference to submission appendix or attachment

Regulatory

[add]

Most recent version of the (draft) product information

[add]

Therapeutic Goods Administration (TGA) clinical evaluator’s report

[add]

TGA delegate’s overview

[add]

Advisory Committee on Prescription Medicines minutes

[add]

Australian Public Assessment Report (AusPAR)

[add]

TGA risk management plan (including Australian-specific appendix)

[add]

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

[add]

  • Food and Drug Administration assessment reports

[add]

  • European Medicines Agency assessment reports

[add]

PBAC

[add]

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

[add]

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

[add]

Publications of all relevant trials

[add]

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

[add]

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

[add]

Periodic safety update report and development of the safety update report

[add]

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

[add]

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

[add]

The full economic model or cost-minimisation spreadsheet

[add]

Financial table workbook

[add]

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

[add]

Other

[add]

a Documents cannot be removed from this list. If a document is not available or not relevant, please explain why. Additional relevant documents can be included in the list.