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ARQon
Feb 62 min read
Australia: Transition from URPTG to PRAC (w.e.f. March 2025)
The Therapeutic Goods Administration (TGA) has announced significant updates to its recall process, slated for implementation in early...

ARQon
Dec 18, 20242 min read
Australia: TGA Updates Labeling Requirements and Guidelines for Injectable Medicines
The Therapeutic Goods Administration (TGA) has announced updates to the labeling requirements and guidelines for injectable electrolyte...

ARQon
Nov 26, 20242 min read
Australia: Key Deadlines for Patient-Matched Medical Devices (PMDDs)
The Therapeutics Goods Administration (TGA) has established a transition period to facilitate smooth transitions and allows continued...

ARQon
Oct 22, 20241 min read
Australia: Critical Challenge for Medical Devices Due to 3G Network Shutdown
Starting on 28 October 2024 , both Telstra and Optus will be shutting down their third-generation (3G) networks. This follows the earlier...

ARQon
Aug 21, 20241 min read
Australia: Prescription Lenses and Their Exemption from Medical Device Classification (15 June 2024)
Compliance effective on 15 June 2024 , prescription lenses for refractive correction are exempted from the requirement for inclusion in...

ARQon
Jul 17, 20243 min read
Australia: Navigating New Regulation Changes for Medical Devices
The Therapeutic Goods Administration (TGA) revised the medical device regulations and introduced the amendments on the 26th of June 2024....

ARQon
Jul 10, 20242 min read
Australia: New Vaping Legislation Effective from 1 July 2024
Australia introduces new legislation, The Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024, to regulate the...

ARQon
Jun 19, 20241 min read
Australia: TGA Adopts PIC/S Guide to GMP Version 16: Manufacturing Principles for Medicines, APIs & Sunscreens (w.e.f 3 September 2024)
On 3 June 2024, the Therapeutic Goods Administration (TGA) amended its Therapeutic Goods (Manufacturing Principles) Determination...

ARQon
May 15, 20241 min read
Australia: TGA Adopts 2021 Sunscreen Standard (w.e.f 1 July 2024)
Starting 1 July 2024, the Therapeutic Goods Administration (TGA) will adopt the 2021 Sunscreen Standard (Australian/New Zealand Standard...
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