Marie Thibault

Last week, the China Food and Drug Administration (CFDA) announced a major step up in registration fees for drugs and devices. According to a CFDA press release, the fee for a domestic drug application is now 624,000 yuan (~$100,000), an almost 20-fold increase from the previous fee of 35,000 yuan. Reuters reported that the Chinese fees will differ depending on whether the product is a drug or device, generic, dometic, or imported. 

Though this may seem like a sharp increase, the regulator pointed out that the new fee is still significantly lower than many other countries. According to CFDA, Australia's drug approval fee is still about 50% higher at $158,000, and China's new fee is just a fraction of that in Canada ($283,000) and Japan ($298,000), and just 5% of the nearly $2 million fee in the United States. Prior to the increase, China's fees were extremely low because of "social wages, inflation and other reasons," according to a rough translation of the announcement.

The fee increase will go toward the review and approval of devices and drugs, which the release noted "takes a lot of manpower, material resources." The regulator's review backlog has been increasing. The number of drug applications waiting for review increased by 30% in a year to 18,597 at the end of 2014, according to the regulator's 2014 Annual Drug Evaluation Report. 

CFDA isn't the only regulator that has been struggling with workload. FDA's Jeffrey Shuren, director of CDRH, has admitted that though the agency has reduced device approval times over the last few years, CDRH has dealt with high turnover as talented employees leave for industry, which often offers a lighter workload and better pay.

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie. 

[Image courtesy of KEATTIKORN/FREEDIGITALPHOTOS.NET]