Blog
RSS FeedPosted by Michael Wonder on 17 Oct 2022
Calls for TGA to withdraw Covid drug approval
17 October 2022 - The medicines regulator is facing calls to withdraw its provisional approval for the antiviral drug molnupiravir ...
Posted by Michael Wonder on 08 Sep 2022
COVID-19 vaccine safety report (8 August 2022)
8 September 2022 - To 4 September 2022, the TGA has received 699 reports which have been assessed as likely to ...
Posted by Michael Wonder on 05 Sep 2022
International work-sharing - first medicines approved by all five Access Consortium regulators
2 September 2022 - The TGA has approved two new medicines as part of the Access New Active-Substance Work-Sharing Initiative. ...
Posted by Michael Wonder on 30 Aug 2022
TGA launches new look website
30 August 2022 - The new look website has gone live this evening. ...
Posted by Michael Wonder on 24 Aug 2022
Prescription medicines: applications under evaluation
24 August 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...
Posted by Michael Wonder on 18 Jul 2022
Aussies could get omicron targeted jab earlier than most
18 July 2022 - Australia could become one of the first countries in the world to administer an omicron-specific vaccine, ...
Posted by Michael Wonder on 04 Jul 2022
Report on 'Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives' - TGA response
4 July 2022 - n November 2021 the TGA commissioned MTP Connect to conduct a stakeholder review of the regulatory ...
Posted by Michael Wonder on 28 Jun 2022
Fees and charges: summary from 1 July 2022
27 June 2022 - The TGA has updated its summary of fees and charges effective 1 July 2022. ...
Posted by Michael Wonder on 26 May 2022
Prescription medicines: applications under evaluation (May 2022)
26 May 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...
Posted by Michael Wonder on 16 May 2022
Pfizer settles two lawsuits, starts another over etanercept biosimilar in Australia
17 May 2022 - After agreeing to settle with Amgen over its oncology biosimilars, Pfizer issued a new patent lawsuit ...
Posted by Michael Wonder on 13 May 2022
TGA removes age limit for BBIBP-CorV (Sinopharm) COVID-19 vaccine recognition for international travel to Australia
13 May 2022 - The TGA has determined that the BBIBP-CorV (Sinopharm) COVID-19 vaccine will be 'recognised' for all ages for ...
Posted by Michael Wonder on 19 Apr 2022
iHealthScreen announces TGA approval for iPredict automated AI system for early diagnosis of diabetic retinopathy, age-related macular degeneration and glaucoma suspect
19 April 2022 - iHealthScreen is the first company in the USA to receive a CE certification, Australian Health approval, and ...
Posted by Michael Wonder on 30 Mar 2022
Drug trials a ‘ticking time bomb’: ex-TGA agent
28 March 2022 - A former TGA official who led the regulator’s inspections program has warned that a lack of ...
Posted by Michael Wonder on 28 Mar 2022
2022 seasonal influenza vaccines
25 March 2022 - The Australian Influenza Vaccine Committee has reviewed data related to epidemiology, antigenic and genetic characteristics of recent ...
Posted by Michael Wonder on 06 Mar 2022
Australian COVID nasal spray not on shop shelves amid TGA dispute
4 March 2022 - Melbourne start-up Starpharma is at loggerheads with the medicines regulator over the approvals process for its ...