As China Moves Faster on Clinical Trials, Can Australia Keep Pace?

27 June 2025

As China Moves Faster on Clinical Trials, Can Australia Keep Pace?

China is once again shifting gears in biotech. Under a new draft policy, the country’s drug regulator is proposing to halve its clinical trial review period for novel medicines—from 60 to just 30 working days. If adopted, it would bring China in line with the FDA in the US and further cement its position as a global hub for drug development.

For global pharma, the implications are hard to ignore. Faster review means faster access to human data. And in a sector where speed to proof-of-concept can define commercial viability, this matters. Already, Chinese biopharmas are attracting unprecedented licensing interest from global players—31% of in-licensed molecules by large pharma in 2024 came from China. That’s up from just 3% in 2015. With shorter trial timelines, the feedback loop from bench to bedside—and to boardroom—is tighter than ever.

So where does this leave Australia?

The question is particularly relevant in light of the New Frontier Inquiry and the recent HTA Review, both of which underscore a common challenge: Australia’s current regulatory and reimbursement pathways aren’t designed for speed. While our clinical trial ecosystem is highly regarded, delays in access, lengthy HTA assessments, and outdated cost-effectiveness models remain pain points for life sciences companies—especially those working on advanced and emerging therapies.

The New Frontier Inquiry highlighted these gaps explicitly. It called for fit-for-purpose pathways to ensure Australians can access innovative medicines without undue delay. The HTA Review aimed to operationalise that vision—proposing changes such as adjusting value frameworks, incorporating broader measures of benefit, and reducing decision timelines. But implementation remains slow, and for companies navigating both regulatory approval and reimbursement hurdles, the frustration persists.

China’s acceleration isn’t just about national pride—it’s strategic. By giving local biotechs a head start in early trials, it positions them as attractive partners for multinational drug makers. And by embedding speed into the system, it ensures promising compounds reach the global stage faster.

Australia has much to offer—world-class researchers, strong clinical governance, and deep relationships between academia and industry. But if timelines continue to stretch and pathways remain rigid, we risk becoming less competitive in a market that’s moving quickly.

Speed, of course, shouldn’t come at the cost of rigour. But it’s increasingly clear that if we want to be part of the global conversation on innovation, we need to speak the same regulatory language. The opportunity is there: through HTA reform, smarter trial incentives, and streamlined approval mechanisms, Australia can still position itself as a partner of choice for cutting-edge biopharma. But the clock, as ever, is ticking.