Australian and New Zealand regulators join forces, paving the way for smoother medtech approval

I've been looking for an excuse to write about Australia for awhile. Last year, I was lucky enough to travel there, and while I (thankfully) never needed any medical attention, I was hoping I'd have a reason to bring the country into our medtech blog soon. Similar to Canada though, Australia tends not to make the news headlines that much everyone is so focused on the massive (and struggling) US, European, and Japanese markets or the ballooning BRIC markets that articles on our smaller countries don't often come through my newsfeed. Nonetheless, with some digging, I did find some interesting things going on in Australian medtech that I thought might be worth a post.

Primarily, the Australian and New Zealand authorities have recently begun the process to merge their regulatory systems under a new agency: the Australia New Zealand Therapeutic Products Administration (ANZTPA). So far, a number of steps have been taken in this direction. For example, in recent months, the two countries have been working together to launch new systems for adverse event reporting and early warning systems on drugs and devices. In the long term, this harmonization would ideally allow products to go through a single regulatory review before receiving approval for use in both Australia and New Zealand, a vision anticipated to be realised around 2015 or 2016.

Really, this is indicative of a larger trend we're seeing in the medtech industry regulators in Europe are attempting to harmonize their approval processes, while regulatory authorities from Australia, Brazil, Canada, and the US have also committed to better harmonize medical device review processes so that an approval in one country could be more easily leveraged to another.

Maybe a world where a given device only needs to be approved one time isn't so far off.