Part 3 of 5 in our series: What Makes a Modern CRO?
Inside HiRO’s Global Growth Story
A Dozen Regulatory Environments, Not One Market
For sponsors weighing where to run a global trial, Asia isn’t a single market, it’s a dozen different regulatory environments moving at different speeds.
HiRO Founder & CEO, Karen Chu walks through how those environments are evolving, and what it takes for FDA and EMA to accept the data that comes out of them.
Will FDA and EMA Accept Data from Asia?
This is the question every sponsor eventually asks, and the honest answer is: it depends on the science, not the geography. Both agencies evaluate foreign trial data against a consistent set of questions. Are there intrinsic or extrinsic ethnic factors, biological differences, variations in medical practice, differences in standards of care, that could affect how a drug performs across populations? Is the treatment landscape in the trial setting genuinely comparable to the market where approval is being sought, particularly around whether a therapy would be used as first-, second-, or third-line treatment?
Patient diversity cuts both ways here. Just as U.S. regulators increasingly push for more diverse trial populations, they’ll scrutinize a dataset that’s heavily concentrated in one ethnic group and ask how broadly the results generalize. None of this is a binary yes/no gate, it’s a case sponsors need to actively build, with a clear scientific rationale for why the data applies to the population they’re seeking approval for.
China: Fast-Moving, But Rarely a Surprise
China’s regulatory environment continues to evolve quickly, but new rules rarely arrive without warning. Authorities typically signal direction well ahead of implementation, which gives sponsors real runway to prepare.
Decree No. 828 is the current example worth watching. It strengthens lifecycle oversight under China’s Drug Administration Law and puts more responsibility on sponsors for safety, quality, and compliance from early development all the way through commercialization. It’s a meaningful shift, especially for sponsors working in cell and gene therapy, where regulatory expectations often diverge from traditional clinical development norms.
The Rest of the Map Is Getting More Competitive
China isn’t the only market redrawing the picture:
Japan was long viewed as expensive and operationally slow but has become notably more competitive in recent years. While holding onto its reputation for high-quality execution and reliable recruitment.
South Korea continues to be a strong performer in specific therapeutic areas, gastrointestinal cancers in particular. Supported by high-volume academic centers and strong physician-led research networks.
Taiwan is working to streamline trial efficiency by aligning hospital systems and simplifying processes like site contracting.
The Philippines is emerging as an increasingly attractive location for vaccine and infectious disease studies, backed by large, treatment-naive patient populations.
Malaysia is drawing similar interest for its multi-ethnic patient diversity and streamlined ethics review timelines.
The Practical Takeaway
For sponsors, the real strategic question isn’t “should we run trials in Asia”, that ship has sailed. It’s which country fits which phase, indication, and regulatory pathway, and how to build the scientific justification that FDA and EMA will expect regardless of where the data originates. That’s a moving target, and it rewards sponsors who work with partners tracking these shifts in real time rather than relying on where a trial “used to” make sense.
