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Significant TGA Fee Increases for Medical Devices in FY24

The Therapeutic Goods Administration (TGA) have released its consultation paper on the proposed fees & charges model for the 2023-24 Financial…

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Events & Webinars,

Commercial Eyes focuses on Rare Disease Day 2023

On Rare Disease Day 2023, the Commercial Eyes team stands with the rare disease community and recognise their strength and resilience. We encourage all stakeholders to work together to support…

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Events & Webinars,

2023 Kosi Challenge with Rare Cancers Australia

Commercial Eyes to join Rare Cancers Australia in our first Kosi Challenge. The work we do every day with clients and stakeholders confirms how devastating cancer is to the Australian community….

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Pricing & policy decisions: Do you have an external or company only view?

The effectiveness of one intervention compared to another, also known as the treatment effect, is frequently a key consideration when assessing the cost-effectiveness of alternative therapeutic interventions for economic…

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A high-quality Medical Information service is an investment in patients and the healthcare system, not a commodity.

Despite being readily accessible to patients and health care professionals, Medical Information remains an underutilised resource….

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Facing Challenges in Medical Information

We really do pride ourselves on efficiency and quality. We aim to respond and provide quality information in a timely manner, as we understand the urgency of these enquiries and…

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Extended hours for Medical Information Service

The need for Medical Information services outside the standard 9am to 5pm AEST business day has become increasingly important and is required by sponsors nationally and globally. With having extended…

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Navigating Significant Safety Issues

In recent years public expectations for rapid identification and the prompt management of emerging safety issues has grown exponentially, with drug safety coming to the forefront of many consumers’…

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Using Overseas Approvals for Medical Devices to Enter the Australian Market

In May 2017, the TGA issued a public consultation to seek feedback on the proposed use of marketing approval by comparable overseas regulators for devices manufactured overseas, to support inclusion…

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Navigating challenges throughout the lifecycle maintenance process can be complex.

A regulatory agency expectation for the sponsor following the registration of a therapeutic good in Australia or New Zealand is keeping the licence up to date. This is undertaken through…

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Easing the GMP Clearance burden

Prior to submitting a new medicine for registration or listing, TGA require the sponsor to have already submitted GMP Clearance applications for overseas sites involved in the manufacture of the…

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