Australian Prescription Medicine Pathways – Project Orbis

Project Orbis is an initiative of the US FDA Oncology Centre of Excellence (OCE). The intent of Project Orbis is to provide a framework for concurrent submission and review of...
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TGA Advertisement Framework Revisions Hard at Work During Pandemic Times

Marking the second year after the issuance of the revised TGA Advertising framework, the TGA has evidenced a strong hard-line position on enforcements against the illegal import, supply, and advertising...

What you need to know about disinfectants in Australia

In May 2020, we looked at hand sanitisers and TGA’s exemption on certain formations in response to the COVID-19 emergency. As we are seeing an increasing number of corporations receiving...
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That’s ODD: can your medicine benefit from incentives for treating rare disorders?

The time, resources, and costs of developing and marketing medicines are extensive – putting treatments for rare disorders at a distinct disadvantage since the potential return on investment is limited...
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TGA published review of safety and performance issues in Medical Device software

Software as a Medical Device (SaMD) In recent years software usage has become ubiquitous and software resources, particularly mobile apps accessible through smartphones, have increased in complexity and usage. The...
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FAQs Regarding the Australian R&D Tax Incentive and Regulatory Services

The Australian R&D Tax Incentive and Regulatory Services As we navigate through the global pandemic of COVID-19, Australian R&D Tax Incentives continue to be of significant relevance for companies exploring...
Changes ahead

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...
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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...
Medicine packaging

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...


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