Chinese drugmakers with big ambitions struggle to recruit staff for global expansion
XLV•Regulators want more diverse trial data
Chinese drugmakers are expanding overseas as regulators seek clinical data from more diverse patient populations.
Former U.S. FDA drug evaluation chief Richard Pazdur said multi-regional trials allow regulators to compare results across countries, helping determine whether differences in efficacy or safety reflect data quality, ethnic differences in patients or variations in medical practice.
"I think if, when there are studies exclusively done in China, then some people may wonder about how applicable those results are," he told Reuters.
Japan's Pharmaceuticals and Medical Devices Agency told Reuters that most new drugs approved in Japan require clinical data from Japanese patients rather than relying solely on studies conducted in Chinese populations.
A recruiter said the talent shortage can force Chinese drugmakers to rely on overseas partners when conducting international clinical trials, though it was more likely to slow execution than derail expansion plans altogether.




