Australia

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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.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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.

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.

Generics Bulletin reviews the latest regulatory events across the world.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 30 documents have been posted on the tracker since its last update.

Warning letters to SuXiang Medical Instrument in China and Yahon Enterprise in Vietnam among recent warnings FDAS sent to OTC drug and supplement manufacturers, including a Florida firm, White Label Leaf, warned about selling gummies containing delta-8 THC, and other OTC skin care product firms.

The TGA says that introducing shorter full-scope inspections will allow it to reduce the backlog while maintaining regulatory oversight and reducing business disruption caused by delays to re-inspections.

Medical device regulatory reliance and recognition of third-party regulators’ approvals have been making news in the UK, but in certain other markets the practice is well established. International regulatory experts explained their experiences at the MedTech Forum 2024.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

The off-label “cosmetic” use of GLP-1 receptor agonists such as Ozempic and Wegovy is contributing to global shortages of these drugs, prompting the European Medicines Agency to ask member states and manufacturers to “control and optimize” their use.

The FDA commissioner said that supply chains will remain interconnected no matter how much nationalism dominates the political landscape, meaning international cooperation will still be necessary.

A targeted review of the rules on labeling for injectable medicines is being carried out in advance of a wider updating of labeling requirements that took effect in 2020.

Australia-based Nexsen BioTech is developing StrepSure, a rapid lateral flow test for detecting Group B Streptococcus (GBS) infection in pregnant women. Designed to provide results within 15 minutes, with the potential to save "millions of babies’ lives,” StrepSure will be assessed in a 5,000-patient clinical trial targeted for summer 2025, which will support Australia and US submissions for market authorization. Thomas Hanly, Nexsen managing director, discusses. 

“Clear Eyes is a perfect example where we're dual-sourced and two facilities don't usually go down at the same time. This was just a quite an anomaly,” says CFO Christine Sacco, noting PCH works with more than 100 contract manufacturers.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.