Blog
RSS FeedPosted by Michael Wonder on 03 Dec 2018
Zambon announces approval and ARTG listing of safinamide in Australia for treatment of patients with Parkinson’s disease
30 November 2018 - Further regulatory submissions on-going with authorities worldwide. ...
Posted by Michael Wonder on 03 Nov 2018
It feels dodgy': parents bypass TGA to buy sleep drug from overseas
4 November 2018 - Consumers are circumventing Australian regulations to buy cheap melatonin from overseas where it can be obtained ...
Posted by Michael Wonder on 02 Nov 2018
Comparable overseas reports pathway - first registration decision
2 November 2018 - Cabozantinib (Cabometyx) is the first medicine to be registered on the Australian Register of Therapeutic Goods ...
Posted by Michael Wonder on 01 Nov 2018
Update on the Australia-Canada Mutual Recognition Agreement
1 November 2018 - Common Statement regarding inclusion of Active Pharmaceutical Ingredient in Australia-Canada Mutual Recognition Agreement (as of November 1, ...
Posted by Michael Wonder on 12 Oct 2018
TGA fees and charges: summary from 1 July 2018
12 October 2018 - The TGA is required to recover its costs for all activities that fall within the scope of ...
Posted by Michael Wonder on 09 Oct 2018
WA family forced to pay $40k a year for son's medicinal cannabis
9 October 2018 - When Perth mother Lisa Johnson gave the first drops of cannabis oil to her severely disabled ...
Posted by Michael Wonder on 09 Oct 2018
TGA business plan 2018-19
9 October 2018 - The business plan sets out our product regulation, regulatory reform, international engagement and regulatory compliance agenda for ...
Posted by Michael Wonder on 09 Oct 2018
Medicine shortages in Australia – what are we doing about them?
2 October 2018 - The first objective of the Australian National Medicines Policy is to provide ‘timely access to the ...
Posted by Michael Wonder on 27 Sep 2018
TGA annual performance statistics report: July 2017 to June 2018
27 September 2018 - The statistics contained within this report cover the period 1 July 2017 to 30 June 2018, ...
Posted by Michael Wonder on 26 Sep 2018
The health industry as an economic priority for Victoria, joint statement
26 September 2018 - Victoria has world-leading competitive advantages in the health industry, which encompasses health and medical research, biotechnology, ...
Posted by Michael Wonder on 24 Sep 2018
Thousands affected by prescription medicine shortages
23 September 2018 - The TGA expects to notch 2018 up as one of the worst years on record for ...
Posted by Michael Wonder on 24 Sep 2018
Sun Pharma announces Australian TGA approval of Ilumya (tildrakizumab) for treatment of moderate-to-severe plaque psoriasis
21 September 2018 - Sun Pharma today announced that it has received the Australian TGA approval for its speciality product, Ilumya ...
Posted by Michael Wonder on 21 Sep 2018
New indication for Opdivo (nivolumab) after TGA approval for hepatocellular carcinoma
21 September 2018 - Opdivo now approved in Australia for eleven indications across seven cancer areas in under three years. ...
Posted by Michael Wonder on 18 Sep 2018
Australia unveils strategy for engaging with foreign regulators
17 September 2018 - Australia’s TGA revealed a three-part plan on Monday to operationalise its strategy on engaging international regulators ...
Posted by Michael Wonder on 18 Sep 2018
TGA international engagement strategy: operations plan 2018-19
17 September 2018 - To support Australian regulatory decisions the TGA considers international reports and evaluations, monitor early warnings and ...