By now, we should all be very familiar with the new Form for providing Product Information (PI) for Australia. Each time you make a change to a PI, be it safety-related or otherwise, you’re required to provide the updated PI to TGA in the new format. The looming deadline for marketed product PIs to be

We may have a global market but do we really consider options outside of USA and EU when developing our Therapeutic Product Commercialization strategy? The USA, EU/UK are large markets with clear regulatory requirements, so they are often first targets for therapeutic product commercialization, either for medicines or medical devices.  A New Perspective But what

Since 2015, Medsafe NZ, the New Zealand Medicines and Medical Devices Safety Authority, has been working on a new therapeutic products regulatory regime to replace and modernise the regulatory arrangements for medicines, and provide regulation of all therapeutic products. Whilst we are still waiting for the progression of the Therapeutic Products Bill through parliament, the