Tag: TGA
TGA updates Australian manufacturing licences with new approvals and regulatory actions
The Therapeutic Goods Administration (TGA) has released its latest list of decisions relating to Australian manufacturers licensed to produce therapeutic goods, outlining new manufacturing approvals alongside changes to existing licences as part of its ongoing regulatory oversight.
TGA seeks public feedback on new manufacturing rules for medicines, medicinal gases
Manufacturing guidance covering medicinal gases, qualification, and validation processes is being considered under two concept papers released for public consultation, according to the Therapeutic Goods Administration (TGA).Â
TGA urges manufacturers to provide feedback on updated GMP guidelines
The Therapeutic Goods Administration (TGA) is encouraging Australian manufacturers to take part in an international consultation on proposed updates to Good Manufacturing Practice (GMP) guidelines, as the standards move to reflect advances in digital technology and artificial intelligence.
TGA grants stem cell manufacturing licence to Magellan Stem Cells
Melbourne-based biotechnology company Magellan Stem Cells has secured a manufacturing licence from the Therapeutic Goods Administration (TGA), a move expected to reduce Australia’s reliance on overseas bio-tech manufacturers and bolster local research into stem cell therapies.
Cann granted GMP manufacturing licence for Mildura facility
The Therapeutic Goods Administration (TGA) has granted Cann Group Limited a GMP licence to manufacture therapeutic goods, which includes GMP testing at its Mildura facility.
Cann...
TGA approves domestic manufacture of AstraZeneca vaccine
CSL has been given the nod by the Therapeutic Goods Administration (TGA) to commence the manufacture of the AstraZeneca COVID-19 Vaccine (ChAdOx1-S) in Australia.
TGA’s...
CSIRO now set to develop new medicinal cannabis products
CSIRO will work hand-in-hand with local manufacturers to develop new medicinal cannabis therapeutics – a move that will also make room in the local...
Government should invest in Australia’s vaccine manufacturing capability – The Greens
In light of recent AstraZeneca approval for use in Australia, the political party reiterated the need to further diversify jab availability in the country.
The...
CSL makes record 45% profit leap, takes on vaccine manufacturing
As demand for vaccines ramps up, the blood products giant has taken on the enormous task of manufacturing COVID-19 jabs – and so far,...
TGA OKs Novartis CAR-T cell therapy manufacturing in Melbourne
With TGA approval in check, Melbourne will house Australia's first and only commercial manufacturing site for the promising cancer treatment.
Swiss pharmaceutical company Novartis announced...
Featured Article
Behind the Australian Made logo: Six manufacturers shaping local industry
Australian manufacturers are continuing to invest in local production, innovation and sustainability across a wide range of industries. From textiles and packaging to construction and advanced manufacturing, Australian Made licensees are developing products tailored to local conditions while supporting Australian jobs and capabilities.
