Australia Updates
Australia Profile Updated
Apr 9, 2025 - The Australia profile in ClinRegs has been updated with the following information, which is current as of February 5, 2025:Investigational product requirements from the Therapeutic Goods Administration (TGA)’s 2024 adoption of the 2022 PIC/S guide to good manufacturing practice (See Manufacturing ...
Australia Profile Updated with Revised TGA Fee Schedule
Jul 3, 2024 - 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, 2024 (See Regulatory Fees).Sources Revised During this Update:(Guidance) Fees and Charges: Summary - From ...
Australia Profile Updated
May 2, 2024 - The Australia profile in ClinRegs has been reviewed and updated with the following information:Revised National Health and Medical Research Council (NHMRC) guidance on ethics committee requirements and research governance responsibilities of institutions (See the Ethics Committee topic, Submission ...
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) ...
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