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…
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…
TGO 91 and TGO 92 – are your labels ready?
Sponsors should check that their medicine labels comply with the relevant…
Does social prescribing impact broader health outcomes?
Whilst the term may be relatively new to mainstream practice in Australia, the idea is…
Coronavirus (COVID-19): Information on medicines and medical devices supply in Australia
Access the latest information about the special regulatory requirements for the supply of medicines and devices (including exemptions) in Australia during the…
Improved Consumer Medicine Information template
The TGA have now released implementation dates for the updated Consumer Medicine Information (CMI)…