Australia TGA changes ARTG Inclusion Process for Non-Measuring, Non-Sterile Class I Medical Devices
From 1 October 2020, the process by which the TGA includes Class I non-measuring, non-sterile medical devices in the Australian …
Australia TGA Launched New Early Scientific Advice Service
The Therapeutic Goods Administration (TGA) has launched a new initiative – the Early Scientific Advice service – that enables applicants …
UK MHRA to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium
The Medicines and Healthcare products Regulatory Agency (MHRA) is the latest regulator to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium. To accommodate …
Australia Publishes Guidance for Creating Summary Page for Consumer Medicine Information (CMI)
The guidance published by the Therapeutic Goods Administration (TGA) on August 2020, gives direction about setting up the summary page …
Australia Accepts Recommendations from Review of the Reforms to the Therapeutic Goods Advertising Framework
In 2018, the Hon Greg Hunt MP, Minister for Health, committed to a review of the impact of the new …
Australia TGA Updates the Guidelines for Applications for New Substances in Listed Medicines
TGA has issued an updated version 2.0 Australian regulatory guidelines for Applications for New Substances in Listed Medicines in August …
Australia TGA to Review Listed Medicines with Traditional Indications in Second Half of 2020
The Therapeutics Goods Administration (TGA) of Australia on 02 July 2020 has a guidance document announcing a compliance review of …
Australia TGA Issues a Notice on Transition to New GMP Requirements for Medicinal Products
Therapeutic Goods Administration(TGA) of Australia will adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal …
TGA Publishes Specification on Release of Information on Clinical Trials of Therapeutic Goods
On June 2020, The Therapeutic Good Administration (TGA ) of Australia has released The Therapeutic Goods (Clinical Trial Inspections) Specification …
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