Are you ready for the mandatory transition to eCTD for prescription medicines?
A staged implementation has been proposed for prescription medicines to reflect the current industry uptake of the eCTD format. The transition begins with new chemical entity, new biological entity, biosimilar…
Making the most of complementary medicines reforms
In March this year the TGA finally started rolling out the long awaited Complementary Medicine…
The long road to PBS listing for Orkambi
With its recent stint on Sunrise, Orkambi is a high-profile example of what can occur when both the PBAC and the sponsor are unable to reach agreement on the value of a…
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…
Ready? Get Set…Go! Planning the most appropriate strategy for your product to enter the Australian market
The key to a successful plan is finding the right resources to help us make informed decisions that suit our…