How to Register a Medicine in Australia
Six ways to register a medicine in Australia: Understanding the complexities of medicine registration. In the dynamic landscape of pharmaceuticals, securing registration for a new medicine requires a nuanced understanding of regulatory procedures and individual client needs. The process involves meticulous planning and strategic vision to ensure successful registration. However, beyond the intricacies of registration,…
Navigating the Hong Kong Medicines Regulatory System
The Year of the Dragon stands as a fitting emblem for Hong Kong’s medicines regulatory system, symbolising strength, resilience, and vigilant oversight
Custom-made Medical Devices in Australia: Now it’s Personal(ised)
Recent changes in TGA Medical Device Regulations In December 2020, TGA released a new Personalised Medical Device Guideline along with a suite of new names and definitions that have shaken up the niche and specialised Custom-made Medical Devices sector. The new guidance reflects amendments to the Therapeutic Goods (Medical Devices) Regulations 2002, meaning that compliance
Is Artificial Intelligence Becoming Too Smart for Regulators?
Is Artificial Intelligence Becoming Too Smart for Regulators? AI is Everywhere and it isn’t that New! The term ‘artificial intelligence’ (AI) was first coined in the 1950s. Since then, this disruptive idea has come a long way from concept to reality. From enhancing photos for your social media page to detecting diseases from medical images
EU MDR: Are ROW Device Sponsors Ready for the Ripple Effect?
The long-awaited transition to the EU Medical Devices Regulation (MDR) is looming. The regulatory realm of medical devices is in a state of flux and poised on the brink of the most significant change to the landscape in decades. Despite the postponement of the EU Medical Devices Regulation’s implementation to May 2021 appearing to offer
Australian Government Cash Splash on High Tech Recovery
Australian science and technology sectors are talking about a ‘research revival’ as the Federal Government splashes the cash in the 2020 Budget. 2020 Budget Cash Splash Thanks to COVID-19, early October saw the first Australian federal budget delivered in a recession in 30 years. The Treasurer said personal income tax cuts, infrastructure spending, and business
The Pointy End of the TGA (PI) Reformatting Transition Period
By now, we should all be very familiar with the new Form for providing Product Information (PI) for Australia. Each time you make a change to a PI, be it safety-related or otherwise, you’re required to provide the updated PI to TGA in the new format. The looming deadline for marketed product PIs to be
Australian Employment Regulations
Today, we are pleased to introduce one of our affiliates and guest blogger, Anna Pannuzzo from WorkPlacePLUS. In this post, Anna discusses some key workplace health, safety and other legal aspects of setting up or maintaining a sales office in Australia. Expanding your business can be an exciting time, but setting up abroad comes with…
Advertising Therapeutic Goods in Australia
If you’re advertising therapeutic goods in Australia in 2019, there’s new legislation that is critical to your successful campaign/s. We’ve been keeping up to date over the break to ensure we’re ready to assist our clients with all of their commercialization needs around the globe.
Disclaimer:
The information provided is intended for general informational purposes only and does not constitute legal, professional, or any other type of advice. While every effort has been made to ensure the accuracy and reliability of the information, the authors make no representations or warranties, express or implied, regarding the completeness, suitability, or applicability of the content to specific products or situations.