Australia’s Transition for Permitted Indications for Listed Medicines Ends 5 March 2021

On 6 March 2018, the TGA implemented a list of permitted indications for medicines listed under section 26A of the …

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Australia TGA Designs a New Regulatory Framework for Personalized Medical Devices (Including 3D-Printed Devices)

Under the current medical devices, regulatory framework custom-made medical devices are exempt from the requirement to be included in the …

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Australia TGA’s Staged Transition to eCTD-only for Prescription Medicines from 1 November 2020

This transition will see Australia adopt best practice standards that are currently applied across the world. Providing benefits for both …

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Australia TGA to Allow Registration of Over-The-Counter Low Dose Cannabidiol

Australia Therapeutic Goods Administration (TGA) announced on 15 December 2020 a final decision to down-schedule certain low dose cannabidiol (CBD) preparations from …

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Australia TGA Issued a New Version of Priority Applicant Guidelines for Medical Devices (including IVDs)

TGA has issued a new version of priority applicant guidelines for medical devices (including IVDs) The purpose of these guidelines …

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Australia has Declared that Certain Sports Supplements are Therapeutic Goods

The TGA, has made a legislative instrument. The Therapeutic Goods (Declared Goods) Amendment (Sports Supplements) Order 2020 (“the Amendment Order”) …

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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 …

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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 …

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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 …

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