China’s Food and Drug Administration (CFDA) set a goal to push drugs to clinics faster. How will they accomplish this goal? Recent policy proposals suggest CFDA are looking at the US Food and Drug Administration (FDA) for answers. Imitation is the greatest form of flattery, right?
The new CFDA policy proposals are twofold. First, they suggest loosening restrictions on trial sites. By backing away from the current certification system, which requires any facility trying to conduct new clinical trials to go through a “laborious certification process,”1 CFDA should be able to foster new trial sites. Second, the agency is proposing a “no response means approval mechanism akin to the U.S. FDA’s trial approach [which would] cut the waiting time for researchers starting new studies.”1
CFDA’s proposed changes (Chinese) posted last week are very similar to the U.S. FDA’s Investigative New Drug (IND) process. The agencies current rules require a drug company to wait for CFDA’s official approval before proceeding with a clinical trial. Under the proposed rule, the agency would be allowed only 60 working days to reject or question an application before the application would automatically be considered a go. The 60-day deadline would still exceed U.S. FDA’s 30-day response window, but greatly reduce the 195-day average that CFDA currently maintains.1
It remains to be seen whether CFDA is capable of such a significant reduction of approval time. Still, reducing the red tape around trial sites and speeding up IND evaluations could do wonders for innovation within China’s life science sector. Demand for trial sites has “been scarce for years…the number of clinical trial sites has been a bottleneck in China for both innovative and generic drugs.”1 These policy proposals coupled with CFDA’s plans to admit foreign clinical trial data to support registration of biopharmaceuticals and medical devices could quickly transform the life science landscape in China.
Pearl IRB will continue to monitor the rules impacting clinical trials and human subject research abroad and domestically. If you need strategic study design support or have are seeking approval for your next study, contact our experts at Pearl IRB.