Update on ANZTPA
Medical Device Regulatory Harmonization in Australia and New Zealand
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).
![](https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhXihlGyi9_PP-LZI1T1NM7dQIQfhyVJI-BkCgPoLY2kEoLfY3NqwRrk0QoCAFyk-Q8A5rUfoNfj2Oe8PrNa5DXily1wH-zsHrD6Z7RnN6q5S1kyPvWshk3b8yt72CGFRVTzfPjPFkhMno/s320/aust.jpg)
- 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.
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