By Stewart Eisenhart, Emergo Group
Medical device market regulators in Australia and New Zealand have implemented a series of projects involving adverse event notification, device recall information and quality system inspections as part of the countries’ long-term effort to establish a single regulatory agency, the Australia New Zealand Therapeutic Products Agency (ANZTPA).
First, the Australian Therapeutic Goods Administration (TGA) and New Zealand’s Medsafe have set up a Joint Adverse Event Notifications System (JAENS) to inform each other of adverse events occurring in their respective markets.
Second, the two regulators have begun an early-warning system to alert healthcare providers in both countries of safety issues involving drugs and medical devices.
Third, the TGA and Medsafe have launched a Recall Portal that provides publically available recall action data on devices and drugs in Australia and New Zealand.
Fourth, the regulators have developed a joint capability for Good Manufacturing Practice inspections in both markets. However, the TGA and Medsafe are still working on final development and implementation of a single GMP Inspection and Licensing system expected to go live once the ANZTPA is fully operational.
The next phase of the TGA and Medsafe’s harmonization effort, expected to take two and a half years, will include developing requirements for submitting manufacturers’ evidence to ANZTPA, as well as identification of Class III and Active Implantable Medical Device product overlap between the two countries.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.