Six uncomfortable regulatory truths in a pandemic
These are truly extraordinary times. With supply chains breaking down and demand outstripping supply for critical products such as ventilators, masks and test kits, both regulators and industry are having...
Getting Shorty – Meeting your obligations for Reporting Medicines Shortages in Australia
Ensuring adequate medicine supply to satisfy market demand is a complex business. Many products can have multinational supply chains using different suppliers of raw materials and ingredients and utilise manufacturers...
TGA acceptance of international device reviews – clearing the fog
A recent discussion on the RAPS bulletin board (link here for members) revealed confusion as to what international evidence can be used to support Australian regulatory approvals for medical devices....
The door to Europe is closed – so where else should I look?
Early in 2019, the European commission was promising that by end of year MDR implementation would be well underway. There would be substantial numbers of Notified Bodies designated to perform...
The question on clients’ lips… “How long will my application take?”
Every year the TGA produce the TGA Annual Performance Statistics Report and the Half Yearly Performance Snapshot. On the 21 October 2019, The TGA released the latest annual statistics on...
TGA Publishes updated MDIR Guide
Last week, the Australian regulator, the Therapeutic Goods Administration (TGA) published an updated guidance for Australian Sponsors and Manufacturers for the reporting of adverse events in Australia (Medical device incident...
TGA Regulatory Business Plan 2019-2020
The TGA Business Plan is updated annually and is a central part of their activity planning and performance monitoring framework. Late September has seen the Australian regulator, the Therapeutic Goods...
Breast implants and anaplastic large cell lymphoma
The TGA has released the latest results from a review into breast implants and tissue expander. Following the extensive laboratory testing, evidence submitted by the sponsors and manufacturers of breast...
