Australia Profile Updated with Revised Fees Document and GCP Inspection Guidance

August 23, 2022
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The Australia profile in ClinRegs has been updated with the following information:

  • Updated Therapeutic Goods Administration (TGA) document regarding fees for the evaluation of unapproved medicines and biologicals (See Regulatory Fees)
  • New guidance on the TGA’s Good Clinical Practice (GCP) inspection program for clinical trial sites (See Quality, Data & Records Management)

Sources Added During this Update:

(Guidance) Good Clinical Practice (GCP) Inspection Program (G-GCP-Inspect) (Version 1.0) (April 2022)
Therapeutic Goods Administration, Department of Health

(Webpage) International Clinical Trials Registry Platform (ICTRP) (AUS-67) (Current as of August 23, 2022)
World Health Organization

Sources Revised During this Update:

(Guidance) Fees and Charges: Summary from 1 July 2022 (G-FeesCharges) (Version 1) (June 2022)
Therapeutic Goods Administration, Department of Health

(Webpage) Clinical Trials (AUS-47) (Last Updated May 23, 2022)
Therapeutic Goods Administration, Department of Health

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