Blog
RSS FeedPosted by Michael Wonder on 18 Nov 2020
TGA grants third provisional determination for a COVID-19 vaccine
18 November 2020 - On 16 November 2020 the TGA granted a provisional determination to Janssen Cilag in relation to ...
Posted by Michael Wonder on 12 Nov 2020
Coronavirus: vaccine rollout for five million Aussies tipped for March
11 November 2020 - The regulator of medicines in Australia has confirmed it expects to be able to approve the ...
Posted by Michael Wonder on 11 Nov 2020
Therapeutic Goods Administration gives green light for early Pfizer vaccine
11 November 2020 - The nation’s medicines regulator has paved the way for an early release of Pfizer’s breakthrough COVID-19 ...
Posted by Michael Wonder on 06 Nov 2020
Clinical Trial Exemption (CTX) scheme renamed as Clinical Trial Approval (CTA) scheme
6 November 2020 - The TGA has changed the name of the Clinical Trial Exemption (CTX) scheme to the Clinical ...
Posted by Michael Wonder on 14 Oct 2020
TGA grants second provisional determination for a COVID-19 vaccine
14 October 2020 - The Therapeutic Goods Administration has granted a provisional determination to Pfizer Australia in relation to its ...
Posted by Michael Wonder on 12 Oct 2020
TGA grants provisional determination for COVID-19 vaccine
9 October 2020 - The Therapeutic Goods Administration has granted a provisional determination to AstraZeneca in relation to its COVID-19 ...
Posted by Michael Wonder on 09 Oct 2020
New transparency measures for prescription medicines
9 October 2020 - The Australian Government has given approval to proceed with two measures to enhance transparency for prescription ...
Posted by Michael Wonder on 03 Sep 2020
Health Department moving TGA to new $60 million Canberra Airport campus
4 September 2020 - The Health Department will leave its ageing Symonston facility in 2022 for a new $60 million purpose ...
Posted by Michael Wonder on 19 Aug 2020
Inquiry into approval processes for new drugs and novel medical technologies in Australia
19 August 2020 - Following a referral on 13 August 2020 from the Minister for Health, The Hon Greg Hunt ...
Posted by Michael Wonder on 16 Aug 2020
Submissions received: scope of regulated software based medical devices
14 August 2020 - A total of 48 submissions were received in response to the Scope of Regulated Software based products ...
Posted by Michael Wonder on 23 Jul 2020
Delays to the commencement of certain medical device regulatory changes
23 July 2020 - The Governor-General in Council has made regulations which delay the commencement of a number of medical ...
Posted by Michael Wonder on 16 Jul 2020
Actual and potential harm caused by medical software
16 July 2020 - TGA publishes a rapid literature review of safety and performance issues. ...
Posted by Michael Wonder on 02 Jul 2020
Cochlear calls for low risk health apps to be exempt from TGA register
3 July 2020 - Hearing implant giant Cochlear has called for some low risk health apps to be exempt from ...
Posted by Michael Wonder on 02 Jul 2020
Reduced annual charges for medical devices listed on the prostheses list
2 July 2020 - In response to the suspension of elective surgery due to COVID-19 and the significant impact this has ...
Posted by Michael Wonder on 23 Jun 2020
Submissions received: fees and charges proposal 2020-21
23 June 2020 - On 20 January 2020, the Therapeutic Goods Administration (TGA) released on its website a consultation paper, ...