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:
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