Registration Fees for Drugs, Medical Devices to Soar in China

May 29, 2015

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."  

http://www.reuters.com/article/2015/05/28/china-pharmaceuticals-idUSL3N0YJ1C020150528