stang

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, and the US Food and …

computer-systems-validation

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).

Sydney GMP Training Course

TGA Launches Pilot of Medical Device Single Audit Program

The Therapeutic Goods Administration (TGA) yesterday 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, and the US Food and Drug Administration …

Medical-ampules

TGA reform of Medical Device Regulation

The TGA has released an exposure draft of a Regulation Impact Statement (RIS) on proposed changes to premarket assessment requirements for medical devices. The RIS is in response to the earlier consultation document on device reforms, released in January.

The …

Regulation of Advertising of Therapeutic Goods

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, advertisers and government.

Advertisements for therapeutic …