Blog
RSS FeedPosted by Michael Wonder on 20 Aug 2018
The regulation of medical devices is flawed and another scandal is inevitable: health advocates
21 August 2018 - More catastrophic failures of medical devices are "almost guaranteed" to happen because there's been no significant ...
Posted by Michael Wonder on 01 Aug 2018
Fast-tracking of new drugs: getting the balance right
1 August 2018 - In Australia, like the rest of the world, patients and their doctors have a growing desire ...
Posted by Michael Wonder on 30 Jul 2018
Special Access Scheme online system
30 July 2018 - On Monday 30 July 2018, an online system was introduced to enable the electronic submission of SAS ...
Posted by Michael Wonder on 13 Jul 2018
TGA calls on drug company to improve warnings over children's asthma drug after suicide
13 July 2018 - The TGA has called on manufacturers of the asthma medication Singulair to add warnings inside the ...
Posted by Michael Wonder on 05 Jul 2018
International work-sharing pilot - apalutamide (Erlyand)
5 July 2018 - Apalutamide (Erlyand) is the first medicine to be registered on the Australian Register of Therapeutic Goods ...
Posted by Michael Wonder on 28 Jun 2018
Medicines Australia welcomes shortages legislation
28 June 2018 - Medicines Australia welcomes the introduction of the Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018 ...
Posted by Michael Wonder on 27 Jun 2018
Sandoz restrained from selling MabThera biosimilar in Australia
21 June 2018 - Australia's first biosimilar interlocutory injunction. ...
Posted by Michael Wonder on 07 Jun 2018
Reform of the orphan drug program - End of transition arrangements
7 June 2018 - On 1 July 2017 amendments to the Therapeutic Goods Regulations 1990 (the Regulations) came into effect that ...
Posted by Michael Wonder on 09 May 2018
Outcomes of the consultation on the draft list of permitted indications
8 May 2018 - On 6 March 2018, the TGA implemented a list of permitted indications for medicines listed under Section ...
Posted by Michael Wonder on 17 Apr 2018
ACSS - NCE work-sharing pilot
17 April 2018 - The ACSS Consortium is a collaborative initiative of like-minded, medium-sized regulatory authorities between Australia's Therapeutic Goods Administration, ...
Posted by Michael Wonder on 03 Apr 2018
Half yearly performance snapshot: July to December 2017
3 April 2018 - The TGA has maintained a high level of activity while also progressing regulatory reforms over the reporting ...
Posted by Michael Wonder on 20 Mar 2018
Provisional approval pathway: prescription medicines
20 March 2018 - As part of the Government's response to the Review of Medicines and Medical Devices Regulation, the TGA ...
Posted by Michael Wonder on 22 Feb 2018
Biosimilar medicines regulation
22 February 2018 - This guidance assists sponsors of biosimilar medicines to complete an application to register their medicine on the ...
Posted by Michael Wonder on 13 Feb 2018
All TGA approvals for prescription medicines in 2017 met the statutory timeframe of 255 working days
9 February 2018 - A recent media report suggesting that half of TGA approvals for prescription medicines in 2017 exceeded ...
Posted by Michael Wonder on 30 Jan 2018
Prescription medicines and biologicals: TGA annual summary 2017
30 January 2018 - This is TGA's fourth annual summary report on the registration of prescription medicines, which includes new generic ...