Registration Fees for Drugs, Medical Devices to Soar in China

Published on: 

May 29, 2015.

Reuters reports that China's drug regulator has steeply raised the fees required to register drugs

and medical devices in the world's second-biggest pharmaceutical market, as a lack of resources and expertise hinders its ability to process a rising number of applications.   A statement this week from China's Food and Drug Administrator (CFDA) stated that a registration of new locally made drug will soar to 624,000 yuan (US$100,637) compared with 35,000 yuan (US$5,700) in 2013. The cost to register a new imported drug will be about US$156,423, according to the regulator. Generic drugs will cost US$81,897 for domestic drugs to $140,247 for imported products.   Reuters reports that China is struggling with a growing backlog of drugs waiting for approval. "There were more than 18,500 drugs in line at end of 2014, up by a third from a year before, reflecting industry concern that it is getting harder to get medicines approved."