Proposed delayed commencement of certain Medical Device Regulatory Changes
During recent months, the world has been focusing on their emergency response to the Covid-19 pandemic, while Manufacturers were still expected to implement transitional arrangements to the new Medical Device...
Software as a Medical Device – Upcoming Changes to the Australian Regulations
With advancements in software and medical device technology extending beyond the current scope of the Therapeutic Goods Regulations, new legislation is due to take effect in August 2020. Since the...
Keeping it Clean: Regulation of Hand Sanitisers as Cosmetics or Therapeutic Goods
The COVID-19 pandemic has seen a marked increase in the production of hand sanitisers. Depending on the composition, intended use and any claims made in relation to their use, hand...
Upcoming TGA Deadlines for Medicine Labelling and Product Information Reform
2020 was flagged to be a big year for TGA Sponsors of Medicines with two long-standing milestones on the horizon. Whilst there is no doubt this won’t be a year...
TGA continues to lead the way in Prescription Medicine Transparency
Several years ago, the Australian Therapeutic Goods Administration (TGA) embarked on a journey to increase the transparency of the Australian prescription medicine evaluation process as part of the Business Process...
Look out…the new CMI templates are finally here
TGA’s updated CMI templates and guidance is finally live on their website! No new or additional content is required in the new templates. The intent was to revise the format...
TGA expedites COVID-19 approvals, while keeping up business as usual for other devices
The TGA continues to provide timely responses and support for new applications and emergency use applications. Our firm continues to be in active communication with the agency, which at the...
Expedite! Emergency device regulatory approvals in a pandemic
These are difficult times – and we need fast, really fast, regulatory reviews. So how does this work – how have regulators adapted to the COVID-19 pandemic? What new and...
Six uncomfortable regulatory truths in a pandemic
These are truly extraordinary times. With supply chains breaking down and demand outstripping supply for critical products such as ventilators, masks and test kits, both regulators and industry are having...
Getting Shorty – Meeting your obligations for Reporting Medicines Shortages in Australia
Ensuring adequate medicine supply to satisfy market demand is a complex business. Many products can have multinational supply chains using different suppliers of raw materials and ingredients and utilise manufacturers...