Blog
RSS FeedPosted 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 28 Mar 2018
Mylan and Biocon receive approvals from the European Commission and TGA Australia for Semglee, biosimilar insulin glargine
27 March 2018 - Mylan and Biocon today announced that their co-developed biosimilar insulin glargine Semglee has received marketing authorisation ...
Posted by Michael Wonder on 27 Mar 2018
2018 seasonal influenza vaccines
27 March 2018 - This year, four quadrivalent and two trivalent influenza vaccines will be available. ...
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 15 Mar 2018
Product withdrawn after overseas reports of inflammatory brain disorders
15 March 2018 - Consumers and health professionals are advised that Biogen Australia, in consultation with the TGA, will withdraw ...
Posted by Michael Wonder on 09 Mar 2018
Better support for patients with low survival cancers and diseases
9 March 2018 - The Australian Government is calling for applications from the country’s best and brightest researchers to help find ...
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 21 Feb 2018
Mandatory requirements for an effective application
21 February 2018 - Applicable for applications lodged from 9 February 2018. ...
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 07 Feb 2018
Priority review pathway - first registration decision
6 February 2018 - Alectinib hydrochloride (Alecensa) is the first medicine to be registered on the Australian Register of Therapeutic ...
Posted by Michael Wonder on 06 Feb 2018
AusBiotech says plan to disadvantage life sciences innovation
6 February 2018 - Response to Innovation and Science Australia 2030 plan. ...
Posted by Michael Wonder on 05 Feb 2018
Cancer research funding has an inherent bias that often excludes rare cancers, expert says
3 February 2018 - The biggest investor in cancer research in Australia needs to address an "inherent bias" in how ...
Posted by Michael Wonder on 05 Feb 2018
Standard deviation and standard error: interpretation, usage and reporting
5 February 2018 - Standard deviations and standard errors are reported routinely in statistical analyses, but the distinction between them is ...
Posted by Michael Wonder on 01 Feb 2018
TGA approves first Humira biosimilar
1 February 2018 - Hadlima was registered by the TGA on 24 January 2018. ...
Posted by Michael Wonder on 31 Jan 2018
Industry needs clarity to invest in Australia
31 January 2018 - Medicines Australia welcomes the release of the 2030 plan by Innovation and Science Australia but seeks ...