You have survived the TGA inspection and are now waiting for the arrival of the dreaded Post Inspection Letter (PIL). Post inspection Letter Following a GMP inspection, the TGA will issue a manufacturer with a PIL. The PIL records any deficiencies identified during the inspection and categorises them as Critical, Major or Other. The deficiencies…
Keeping an eye on medical devices isn’t just a regulatory checkbox—it’s a commitment to patient safety and trust in Australia’s healthcare system. This discussion takes you through the critical aspects of medical device vigilance, shedding light on the essential regulations and offering practical tips for manufacturers, sponsors and healthcare providers. The Pulse of Vigilance: Why…
TGA Updates: New Pathways, Rule Changes, and Updated Application Requirements The Therapeutic Goods Administration (TGA) has implemented several changes that will take effect on 1 July 2024. Read on to determine whether any of these TGA updates could impact your products. Additional Pathway for Medical Devices that are Programmed or can be Programmed/Software as a…
Public health concerns regarding vaping products Every year, more than 8 million people die from smoking-related illnesses, including 1.3 million non-smokers exposed to second-hand smoke. (Source: WHO 2023.) With the evolution of vaping products, including pharmaceutical nicotine vapes, cannabis vapes, and non-therapeutic vapes, people are curious to know if nicotine addictions and smoking-related health harms…
The ethos that high-risk activities should elicit the most significant mitigation effort, and low-risk, lower effort has been a mainstay of the global regulatory approach to risk management of therapeutic products for many years. In 2006, ICH Q9 Quality Risk Management was published and included the statement: The level of effort, formality and documentation of…
In an era where health and well-being are paramount, the pharmaceutical industry plays a pivotal role in ensuring the safety of consumers. However, the reality is that pharmaceutical TGA recalls can and do occur, posing challenges to sponsors. In this Blog, we shed light on how PharmOut can provide support and expertise preventing these critical…
It might seem that changes to pharmaceutical regulations move at a glacial speed but, be assured, that they do move and they are happening. Back in August 2020 (you remember that year – you made a LOT of sourdough), Australia’s Therapeutic Goods Administration (the TGA) announced a consultation regarding amendments to the Poisons Standard. Amongst…
What is the current number of medicinal cannabis prescriptions in Australia so far? In just a few years, the number of medicinal cannabis prescriptions through the Special Access Scheme B (SAS-B) has grown substantially. It still represents a small percentage of the overall Australian population who state they rely on cannabis for medicinal purposes. Only…
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