Tuesday, 17 December 2013

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).

  • 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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