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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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…
How will the new Strategic Agreements impact your business?
Medicines Australia and Generic and Biosimilars Association have secured new 5 year agreements with the Commonwealth for timely access to and reimbursement of medicines and policy settings that recognise the…
New TGA framework to redefine personalised medical devices
This post will cover the recent changes brought to regulation of personalised medical devices, under a new TGA…