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…
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…
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…
Navigating the Complexities of Medicine Registration
For a sponsor considering entering the prescription medicine space, it is important to evaluate all the regulatory pathways possible….
Medicine repurposing – Why start from scratch?
As more products are being registered on the Australian Register of Therapeutic Goods (ARTG) for therapeutic claims beyond their original purpose, there is an increasing potential for medicine…
PBAC Pre-Submission Meetings – What to expect and are they of value?
Stage 1 PBS Process Improvements commenced 1 July 2019 and included the introduction of changes to pre-submission meetings to provide additional guidance and support for complex submissions….
The importance of treatment effects in economic evaluation
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…
Reflections on ISPOR Europe 2024: Implications for Australia from our Head of Access, Research and Intelligence, Jo Atkins
The ISPOR Europe 2024 conference, held last week in Barcelona, focused on the theme “Generating Evidence Toward Health and Well-Being.” The conference offered a thought-provoking exploration of how health economics…
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Commercial Eyes receives marketing award for product launch campaign
Congratulations to Associate Director, Dianne Gill and our Medical Communications & Patient Engagement team for receiving a Diamond Award from Consumer Healthcare Products…
International Women’s Day: Celebrating Women at Commercial Eyes
From the beginning, the company has been a workplace that has embraced and rewarded women for the great work that they…
Medical Devices: Reclassification framework of certain devices
The TGA has commenced the implementation of revised medical device…
Commercial Eyes Proudly Celebrates 20th Birthday!
From humble beginnings and with big aspirations, on this day 20 years ago Commercial Eyes was founded and over the last two decades has grown to be the foremost therapeutics…