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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...
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...
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...