In a move likely to benefit Chinese citizens as well as foreign drug firms, the Chinese government has agreed to accept data from clinical trials conducted outside China for the approval of new drugs.
“Applicants can directly apply for drug listing registration after the completion of the international multicenter drug clinical trials,” the China Food & Drug Administration (CFDA) disclosed in a statement.
Until now, China only approved drugs that had been tested on people in China. And foreign firms could start testing in China only after they had demonstrated the safety of their drug with tests conducted overseas.
This meant that Chinese people gained access to innovative new drugs years after they had been approved overseas—if ever. In the past, many major drug companies did not bother to launch their drugs in China because of the cost and delay involved. By the time foreign-developed drugs gained approval, competing versions were often already available from Chinese firms.
CFDA has been reforming its drug registration process for several years. The agency earlier hired more reviewers to reduce its drug approval backlog. It also warned companies registering drugs in China to withdraw their applications—or face administrative sanctions—if they had doubts about the authenticity of their clinical trial data. The warning helped to reduce the number of applications that the agency had to review.
IMS Health, a market research firm, expects that China will account for 11% of global pharmaceutical spending by 2020. The country is already the world’s second-largest drug market after the U.S.