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…
Hot Topics
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’…
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…