Blog
RSS FeedPosted 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Product withdrawn after overseas reports of inflammatory brain disorders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 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 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 30 Jan 2018
Transforming health care through precision medicine
31 January 2018 - Lately we've both been enjoying ITV's drama Victoria. By all accounts Queen Victoria lived well, dying ...
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 ...
Posted by Michael Wonder on 23 Jan 2018
Registration of new chemical entities in Australia (update)
23 January 2018 - The TGA's publication of registration milestone dates facilitates more meaningful international comparisons. ...
Posted by Michael Wonder on 22 Jan 2018
Registration of new chemical entities in Australia
22 January 2018 - New year leads to improved transparency on regulatory dossier timelines; submission dates yet to be disclosed. ...
Posted by Michael Wonder on 14 Jan 2018
Distributions and what to do when they are non-normal
15 January 2018 - Medical researchers often want to find out how medically relevant outcomes are related to other factors. ...
Posted by Michael Wonder on 11 Jan 2018
Black Triangle Scheme - information for sponsors
11 January 2018 - The eligibility of a product for inclusion in the scheme will be considered in the Risk Management ...
Posted by Michael Wonder on 12 Dec 2017
It’s the law, not the Code – MA’s Director of Ethics and Compliance – Deborah Monk
12 December 2017 - The Director of Ethics and Compliance at Medicines Australia Ms Deborah Monk is troubled that there ...
Posted by Michael Wonder on 08 Dec 2017
Merck receives approval (updated registration) for Mavenclad (cladribine tablets) in Australia
7 December 2017 - First treatment in relapsing-remitting multiple sclerosis to show sustained clinical efficacy for up to 4 years with ...