The electronic CTN form (eCTN)

The electronic CTN form (eCTN)

In Australia, The Therapeutic Goods Administration (TGA) is responsible for the regulation of therapeutic goods (TG) – including medicines, vaccines, medical devices, in-vitro diagnostics and biologicals. They provide oversight over manufacturing, import and export of therapeutic goods, clinical trials (CT) and regulatory approvals processes. Australia is well known for its efficient CT start up timelines; […]

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November 3rd, 2016

Therapeutic Goods Administration Releases New Online Form for Clinical Trial Notification (CTN) Scheme

The Therapeutic Goods Administration (TGA) has released a new online form for the clinical trial notification (CTN) scheme. When a clinical trial is investigating the use of a product within Australia, which is not on the Australian Register of Therapeutic Goods (ARTG), or on the ARTG yet being used outside its marketing approval conditions, these […]

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July 7th, 2015

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