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 …

read more...

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 …

read more...

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 …

read more...

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  …

read more...

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 …

read more...

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 …

read more...

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 …

read more...

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 …

read more...

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 …

read more...

More News