Australia

Generics Bulletin reviews global regulatory developments across the globe.

The Australian Therapeutic Goods Administration proposed a narrower indication that Eisai rejected.

As efforts to improve diversity in clinical trials gain momentum globally, regulators in the UK, the EU, Canada, Australia and Japan were asked about their efforts to support representative enrolment. 

The Therapeutic Goods Administration is advising companies to get up to speed with its new recall procedure, which is designed to improve the timeliness of recalls, alerts and corrections, and reduce regulatory burden for sponsors.

The Therapeutic Goods Administration is advising companies to get up to speed with its new recall procedure, which is designed to improve the timeliness of recalls, alerts and corrections, and reduce regulatory burden for sponsors.

Certa and OccuRx both came out of Fibrotech and are now joining forces to advance asengeprast as a potential therapy for scleroderma and focal segmental glomerulosclerosis.

The Therapeutic Goods Administration says it wants to balance regulatory burden on sponsors with the need to improve its monitoring of medicine shortages.

The government’s decision for the Pharmaceutical Benefits Advisory Committee to hold an extra meeting in 2025 has been welcomed by Medicines Australia, which says that Australians already wait on average 466 days from the time a medicine is approved to when it is subsidized.

Australia’s industry group has updated its code of conduct with a number of new provisions, including one that clarifies its stance on members using its complaints system to disrupt another company's business.

Medicines Australia has expressed skepticism over the Pharmaceutical Benefits Advisory Committee’s claim that in March 2025 it will only be able to assess 32 submissions from companies that want to get their drugs subsidized under the Pharmaceutical Benefits Scheme.