Australia Updates
Australia Profile Updated with Revised Fees Document
Oct 7, 2022 - The Australia profile in ClinRegs has been updated to include a revised version of the Therapeutic Goods Administration’s fees guidelines effective October 1, 2022. No revisions were made to the requirements described in the guidelines.
Sources Revised During this Update:
(Guidance) ...
Australia Profile Updated with Revised Fees Document and GCP Inspection Guidance
Aug 23, 2022 - 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 ...
Australia Profile Updated with Governance Framework Implementation Details
Mar 10, 2022 - The Australia profile in ClinRegs has been updated to include more specific timeline information on the implementation of the National Clinical Trials Governance Framework. (See Submission Content and Timeline of Review)
Sources Revised During this Update:
(Webpage) Australian Commission ...
Australia Profile Updated in ClinRegs
Dec 17, 2021 - The Australia profile in ClinRegs has been reviewed and updated to ensure all information and sources are up-to-date and accurate. While there were no substantial edits to the summary text, some sources were added to the profile to provide supplementary information.
Sources Added During ...
Australia Profile Updated in ClinRegs
Jul 7, 2021 - The Australia profile in ClinRegs has been updated to include the latest clinical trials fees information, effective July 1, 2021 through June 30, 2022. (See Regulatory Fees) ...
Australia Profile Updated in ClinRegs
Jun 24, 2021 - The Australia profile in ClinRegs has been updated to include the following guidelines:
National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia (See Regulatory Authority, Clinical Trial Lifecycle, Sponsorship, Informed Consent, and Investigational ...
Australia: CTX Scheme Renamed CTA Scheme
Nov 11, 2020 - On November 6, 2020, Australia's Therapeutic Goods Administration (TGA) announced that it has changed the name of the Clinical Trial Exemption (CTX) scheme to the Clinical Trial Approval (CTA) scheme.
The name change from CTX to CTA does not involve any process changes, and all ...
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