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…
Medicine labels: TGO 91 and TGO 92. What’s the impact?
The creation of separate orders for prescription and non-prescription medicines was implemented to reflect how the products are used and ensure adequate information is available for the safe use of…
Are you eCTD ready?
While the eCTD format is not currently mandatory in Australia, it is only a matter of time before the TGA joins other global regulators in mandating…
Stressed? Well your products should be!
Stress-testing is an important validation consideration and should be conducted very early in the development or implementation of new test methods rather than leaving it until regulatory authorities raise questions…
Keys to off-label communications
The TGA and the Medicines Australia Code of Conduct are very clear on the appropriateness and dissemination of off-label information to…