Seeking to encourage drug companies to conduct more clinical trials of innovative medicines in China, the Chinese government has proposed new protections on pharmaceutical data.
Under the draft proposal, the China Drug Administration (CDA) would expand data exclusivity—the protection of clinical data submitted to it by one pharmaceutical developer from use by others—to a broader range of pharmaceuticals. Currently, the CDA awards data exclusivity only to drugs in development which contain innovative chemical entities. The new guidelines would extend that protection to both innovative drugs and generic drugs. The protection period would be six years for innovative and orphan drugs and twelve years for innovative therapeutic biologies. Data for pediatric drugs would also be protected for six years.
The protections would bring China’s regulations on pharmaceutical development further into line with those of the United States and other Western countries. Producing clinical test data to develop new drugs is costly, and the pharmaceutical industry argues that allowing data submitted to regulators by one company to be used by others is unfair. In practical terms though, data exclusivity deters potential competitors by preventing the use of data by others.