Hand sanitiser – What do you need to know to supply in Australia?
The COVID-19 pandemic has seen the TGA rapidly changing the regulatory landscape for in-demand products that can help reduce the spread of the virus. Given all the changes taking place,…
Brexit – What’s the impact on medicines and medical devices supplied in Australia?
A transition period is now in effect until the end of 2020 with the possibility for extension. Its status quo for Australia during the transition period, with the current regulations for…
In the digital age of present, patients have never been better equipped with the devices and technologies to take control of their own healthcare needs and outcomes….
Life Saving Drugs Program: new lease on life, or on life support?
The Life Saving Drugs Program currently provides subsidised access to patients with rare and life-threatening conditions to essential and very expensive medicines….
What is Happening with the Provisional Approval Pathway?
When the independent review of medicines and medical devices regulation was announced the pharmaceutical sector immediately saw the opportunity for an expediated approval pathway for certain prescription…
New ‘SmPC’ Format for the Australian Product Information
The TGA have published a new form for providing the product information (PI) which means more work for regulatory teams but an enhancement of the quality use of medicines for Australian patients….