China speeds foreign drug approvals

Abstract

“Dying to Survive,” a low-budget movie popular in China this summer, depicts a peddler of aphrodisiacs who tries to smuggle cancer drugs from India that were too expensive at home. The film’s success highlighted public discontent with drug access in China. Now the Chinese government is taking one step to address the discontent: It has launched a program to speed the review and approval of dozens of drugs sold abroad but not yet approved in China. Foreign companies that had long complained about the arduous path to product launch in China, the world’s second-largest drug market, are seeing the results. On Aug. 20, Roche saluted China’s expedited approval of Alecensa (alectinib), a treatment for certain types of lung cancer. Sandra Horning, Roche’s chief medical officer, commented that the approval “represents a significant regulatory shift, with the approval received under unprecedented timelines.” The drug was first approved in Europe just eight