Hot Topics
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...
Patient programs for improved patient outcomes
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....
Making the most of complementary medicines reforms
In March this year the TGA finally started rolling out the long awaited Complementary Medicine...
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....
Transition to eCTD is gaining momentum in Australia
The TGA announced that applications considered under the priority review pathway will be required to be submitted in eCTD...
What is food for special medical purposes (FSMP)?
With a greater recognition of the importance of nutritional support in medical therapy and improved technology, the “food for special medical purposes” market is currently...
TGA Inspections are Coming – Is your Company Ready?
The TGA has recently concluded its pilot program in Pharmacovigilance inspections in...
Patient support program – the key driver of better health outcomes
Pharmaceutical companies play a key role in supporting the quality use of medicines through patient focused programs. These programs are designed to aid compliance and lifestyle choices....
Warning: This medical device literature review may contain traces of LBS
With the release of new clinical evidence guidelines for medical devices, sponsors and manufacturers will be expecting some further guidance on the structure, content and quality of their clinical evaluation...