Australia's TGA seals regulatory MoU (memorandum of understanding) with Switzerland:
This article was originally published in Clinica
The regulation and post-market monitoring of medical devices and medicines in Australia is to be strengthened by a memorandum of understanding (MoU) with the Swiss therapeutic products regulator, Swissmedic. The MoU effectively formalises co-operative arrangements between Swissmedic and Australia's regulatory agency, the Therapeutic Goods Administration (TGA). The MoU will affect regulatory decision-making in three key areas: the global device vigilance exchange programme; Good Manufacturing Practice (GMP) inspections for medicines; and complementary medicines.
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