Blog
RSS FeedPosted by Michael Wonder on 06 Sep 2022
NASWSI and Project Orbis - are they essentially the same?
7 September 2022 - We compare and contrast the two initiatives to bring new medicines to the market faster. ...
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 14 Dec 2021
Access Consortium statement on COVID-19 medicines
14 December 2021 - Vaccines have played a critical role in fighting the COVID-19 pandemic. However, medicines can still play ...
Posted by Michael Wonder on 13 Dec 2021
ACCC helps to protect Australians against medicine shortages caused by COVID-19
10 December 2021 - Medicine shortages from the COVID-19 pandemic will continue to be actively managed by Medicines Australia and ...
Posted by Michael Wonder on 30 Sep 2021
Medicines industry continues to protect Australians from medicine shortages
30 September 2021 - ACCC extends approval for ongoing collaboration ...
Posted by Michael Wonder on 14 Sep 2021
Access Consortium: alignment with ICMRA consensus on immunobridging for authorising new COVID-19 vaccines
14 September 2021 - Placebo controlled disease outcome trial data are the gold standard for authorising vaccines. However, for COVID-19 ...
Posted by Michael Wonder on 09 Aug 2021
COVID-19 vaccine: international collaboration
6 August 2021 - The Therapeutic Goods Administration has strong working relationships with a wide range of international agencies and ...
Posted by Michael Wonder on 26 Jul 2021
TGA international engagement strategy 2021-2025
26 July 2021 - The TGA's International Engagement Strategy 2021-2025 describes how working with our international regulatory counterparts will benefit Australians ...
Posted by Michael Wonder on 22 Jun 2021
Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium
22 June 2021 - The TGA is a member of the Access consortium along with Health Canada, Health Sciences Authority of ...
Posted by Michael Wonder on 05 Mar 2021
TGA adopts Access Consortium guidance for fast-tracking authorisations of modified COVID-19 vaccines for variant
5 March 2021 - TGA has adopted guidance developed by the Access Consortium - a coalition of regulatory authorities from ...
Posted by Michael Wonder on 08 Feb 2021
TGA one of only five non-European regulators invited to participate on European committees on COVID-19 vaccines and therapeutics
8 February 2021 - Australia, through the TGA, is one of only five non-European Union regulators formally invited to participate ...
Posted by Michael Wonder on 04 Dec 2020
Access Consortium statement on COVID-19 vaccines evidence
4 December 2020 - The medicine regulators from Australia, Canada, Singapore, Switzerland and the United Kingdom (Access Consortium) have discussed the ...
Posted by Michael Wonder on 07 Jun 2020
The University of Queensland, CEPI and CSL partner to advance development and manufacture of COVID-19 vaccine candidate
5 June 2020 - A vaccine is anticipated to be available in 2021 if clinical trials are successful. ...
Posted by Michael Wonder on 05 May 2020
COVID-19: Australia’s pledge to $12 billion virus fight, WHO issues vaccine warning
5 May 2020 - Scott Morrison has promised more than $352 million as part of a global coronavirus vaccine fundraiser, but ...
Posted by Michael Wonder on 05 May 2020
Australia, Canada, Singapore, Switzerland Consortium regulators pledge support to tackle COVID-19
5 May 2020 - The Australia, Canada, Singapore, Switzerland Consortium (ACSS) regulatory authorities have pledged their collective support in countering ...