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 …
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).
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 …
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 …
I am often asked by new Australian-based manufacturers seeking a TGA manufacturing license and implementing a Quality Management System (QMS) what the difference is between a Site Master File (SMF) and a Quality Manual. The confusion is understandable given …
The TGA has released its long-awaited response to the consultation on proposals for reform of pre-market assessment requirements for medical devices. The initial proposals were released for consultation in late 2010.
A number of reforms were initially proposed; the reclassification …
In June 2011, the Australian and New Zealand Governments announced their agreement to proceed with a joint scheme for regulation of therapeutic products (that is, medicines, medical devices, biological and others) to be administered by the Australia New Zealand …
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 …
Regulators from several APEC countries met in Taiwan in early November for the second workshop on Good Review Practices. This was an advanced workshop, following on from the initial meeting held in Taipei in October 2011. The workshop was …
