Australia Updates
Australia Profile Updated with Revised TGA Contact Information
Jan 12, 2024 - The Australia profile in ClinRegs has been updated to include a revised general enquiries email for the Therapeutic Goods Administration (TGA). (See Regulatory Authority)Sources Added During this Update: (Webpage) Get in Touch with Us (AUS-11) (Current as of January 12, 2024)Therapeutic ...
Australia Profile Updated with Revised TGA Fee Schedule
Jul 11, 2023 - The Australia profile in ClinRegs has been updated to include the Therapeutic Goods Administration (TGA)'s revised fee schedule, which took effect on July 1, 2023 (See Regulatory Fees).
Sources Revised During this Update:
(Legislation) Therapeutic Goods Regulations 1990 (Statutory Rules ...
Australia Profile Updated
Feb 10, 2023 - The Australia profile in ClinRegs has been reviewed and updated with the following information:
Data protection requirements related to the collection and handling of personal information, including health information, under the Privacy Act 1988 and the Australian Privacy Principles (See ...
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 ...
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