ARTG

  • Cell and Gene Therapies Regulation

    Cell and Gene Therapies Regulation

    Navigating the Regulation of Cell and Gene Therapies in Australia and New Zealand Globally, cell and gene therapies are revolutionising modern medicine, offering groundbreaking treatments for life-threatening conditions including cancer, genetic disorders and rare diseases. However, despite the pace of scientific innovation, regulatory frameworks in many countries, including Australia and New Zealand, have struggled to…

  • Medical Device Registration in Australia

    Medical Device Registration in Australia

    Key considerations in navigating the regulatory process to register a medical device in Australia. Registering a medical device in Australia is a complex but crucial process that ensures the safety and performance of devices entering the healthcare market. Navigating the regulatory requirements of the Therapeutic Goods Administration (TGA) can be daunting, particularly for new manufacturers…

  • How to Register a Medicine in Australia

    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,…

  • Moderna mRNA COVID-19 Vaccine Approved

    Moderna mRNA COVID-19 Vaccine Approved

    09 August, 2021 – Moderna mRNA COVID-19 Vaccine Approved The Therapeutic Goods Administration (TGA) has provisionally approved Moderna’s mRNA vaccine for use in Australia, in record time. Australia’s fourth approved vaccine, one million doses are due to be released in the second half of September, 2021. The Spikevax (elasomeran) vaccine is provisionally approved and included…

  • Custom-made Medical Devices in Australia: Now it’s Personal(ised)

    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

  • EU MDR: Are ROW Device Sponsors Ready for the Ripple Effect?

    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