Understanding TGA GMP Clearance
Understanding TGA Good Manufacturing Practice (GMP) requirements for Australian Regulatory Submissions Good Manufacturing Practice (GMP) is vital in ensuring the quality, safety, and efficacy of the therapeutic goods for human use (including sunscreens). In Australia, the Therapeutic Goods Administration (TGA) oversees the implementation and enforcement of GMP standards to uphold the integrity of the pharmaceutical…
Choosing the Right Regulatory Affairs Consultant
Whether you are part of an established team, a start-up, an SME, or a founder, navigating the stringent requirements of the Medical Technology, Biotechnology, and Pharmaceutical (MTP) sectors can be complex and challenging. This is where partnering with the right Regulatory Affairs Consultant becomes invaluable. Understanding the Role of a Regulatory Affairs Consultant A regulatory…
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
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
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
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
Blog Posts
Follow along as we discuss the latest changes across the pharmaceutical, biotechnology, medical technology and life science sectors.