China is expected to accelerate the time-to-market of imported drugs to meet the rising clinical demand, according to a draft exposure of decisions on adjusting registration and management of imported drugs issued by the China Food and Drug Administration last Friday. 

The new regulation, which will be open for the solicitation of public opinions through April 20, stipulates that new drugs for clinical trials, except vaccines, will be eligible for international multi-center clinical trials in China, eliminating the previous provision that they should have been registered overseas or entered the phase II or III clinical trials.

Pharmaceutical companies could file applications for the registration and marketing of these drugs in China if they pass international multi-center clinical trials.

For the import of new chemical drugs and innovative biological drugs for therapeutic use, there is no longer a provision that producers must gain marketing approval for these medicines in their own countries or regions. 

Wang Shuguang, business partner of GTJA Investment Group, said that if implemented, the regulation will accelerate the time-to-market of imported drugs in the short run and will drive the advancement of clinical drugs, pharmacy industry, and biomedical science in the long run. 

It will also improve China's new drug assessment system and help Chinese pharmaceutical companies reach international standards, Wang added.  

Email: lansuying@nbd.com.cn