Australia Offers Wave of Potential for Pharma, Medical Device Manufacturers

Gathering momentum and power like a monster wave, Australia's life sciences sector is increasingly becoming a beacon for pharmaceutical and medical device manufacturers seeking regulatory approval for their products.

In recent years, Australia’s regulatory agency, the Therapeutic Goods Administration (TGA), has made strides to become more accessible and user-friendly to pharmaceutical and medtech companies around the globe to make Australia a tempting market destination for their products. At the same time, Australian innovators are putting the world’s largest island nation on the map with ground-breaking research, technologies and products that are making the world take notice.

For instance, the TGA has made available a plan diagram and transition plan tables to manufacturers to help them ease into an updated version of the Pharmaceutical Inspection Co-operation Scheme’s (PIC/S) Good Manufacturing Guide to GMP PE009-13. The guide is intended to promote internationally harmonised manufacturing standards that allow pharmaceutical and biologics companies to operate more smoothly in various markets.

Another trend is that more and more medical device manufacturers are finding that they don’t need CE mark (which signifies European regulatory approval of a product) credentials to access Australia’s growing market potential due to Europe’s evolving Medical Device Regulations (MDR). Instead, they’re going directly to the TGA for their conformity assessment. In turn, the TGA has made a concerted effort to refine internal processes and systems, which have shortened the amount of time it takes manufacturers to navigate the many facets of the medical device registration process.

Check out some of the other compelling news items coming out of Australia for pharmaceutical and medtech companies in recent months:

• In May, Australia’s federal government announced that a major new taskforce will focus on the country’s response to the blood-borne virus HTLV-1. The virus is found in Aboriginal communities at 1,000 times the rate of anywhere else in the world.
• Researchers with the Garvan Institute of Medical Research in Australia have identified a new four-stranded ‘tangled knot’ structure inside living cells chronicled in the journal Nature Chemistry. The discovery may someday yield new clues about chromosomes in DNA that are important to the aging process.
• In May, the TGA delayed implementation of regulatory changes proposed for the additive manufacturing or 3-D printing of medical devices because of commentary from industry stakeholders.
• An insightful Q&A with industry expert Dr. Katharine Giles, a Brandon Capital Investment manager, about the country’s biotech boom and what manufacturers and industry insiders can expect to see over the next 12 months.
• In March, the TGA released a new clinical trial handbook offering manufacturers guidance on the legislative, regulatory and good clinical practice (GCP) requirements for conducting clinical trials in Australia.