New drug therapies to treat serious and life-threatening diseases would be reviewed more quickly under draft regulations under consideration by China’s Center for Drug Evaluation (CDE). The proposed guidelines would allow for priority review and conditional approval of pharmaceuticals deemed to have significant clinical advantages over current treatments, as well as drug therapies for diseases for which no current therapies exist.
Also eligible would be drugs found by government agencies to be in clinically short supply. Under the new guidelines, drugs submitted for approval would be reviewed within 60 days. The guidelines establish procedures mandated by the Drug Administration Law passed by China’s National People’s Congress in August.