Australia

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.

The Therapeutic Goods Administration appears to share similar safety concerns regarding Leqembi as those expressed by the European Medicines Agency when it rejected the drug in July.

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Industry says it is ready to work with the government on the recommendations from a major review of Australia’s health technology assessment system that covers areas such as discount rate reductions and setting up a separate budgetary allocation to temporarily subsidize access to certain drugs.

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The Australian teletrials program has surpassed expectations at its mid-way point and is being used by drug and device sponsors looking to enhance trial participant recruitment and retention by enabling access to rural, regional and remote areas.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.