Follow along as we discuss the latest changes across the pharmaceutical, biotechnology, medical technology and life science sectors.

  • 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,…

  • Enter the Dragon: Navigating Hong Kong’s Medicines Regulatory System in 2024

    Enter the Dragon: Navigating Hong Kong’s Medicines Regulatory System in 2024

    The Year of the Dragon stands as a fitting emblem for Hong Kong’s medicines regulatory system, symbolising strength, resilience, and vigilant oversight

Stay up to date with the latest news and industry developments in Australia/New Zealand and beyond.

Breaking news and updates about the regulation of therapeutic goods in Australia.

  • MEDSAFE NZ Moves Ahead in 2020

    MEDSAFE NZ Moves Ahead in 2020

    Since 2015, Medsafe NZ, the New Zealand Medicines and Medical Devices Safety Authority, has been working on a new therapeutic products regulatory regime to replace and modernise the regulatory arrangements for medicines, and provide regulation of all therapeutic products. Whilst we are still waiting for the progression of the Therapeutic Products Bill through parliament, the

  • Consumer Insecurity / Vanity Targeted by TGA – Massive Fines

    Consumer Insecurity / Vanity Targeted by TGA – Massive Fines

    The appearance of misleading terms and claims on websites and social media has attracted the attention of the TGA. The Therapeutic Goods Administration in Australia (TGA) has advised that fines were imposed via the Federal Court for misleading advertising by Peptide Clinics Australia (Peptide Clinics Pty Ltd), to the tune of $10 million (for breaches…

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