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Entries by Shelley Tang
TGA medical devices

The Medical Device Single Audit Program

In October 2013, the Therapeutic Goods Administration (TGA) announced the launch of the Medical Device Single Audit Program (MDSAP) pilot from January 2014, together with Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, …

TGA signs agreement for eCTD submissions

The TGA has announced that it has signed an agreement to use the docuBridge® software solution to receive, review and process electronic applications for the entry of prescription medicines and other therapeutic products on to the Australian Register of Therapeutic Goods (ARTG).

Regulation of Advertising of Therapeutic Goods

The advertising of therapeutic goods to consumers and health professionals is administered via a co-regulatory system which is representative of all key stakeholder groups, namely consumers, health professionals, the regulated industry sectors, the media, …