China releases Draft “urgently needed” drugs list (2nd batch)for Fast Track, Accelerated Approval, Priority Review
On March 28th, China Center for Drug Evaluation (CDE) released an “urgently needed” new drugs list for fast track, accelerated approval, priority review which contains a list of 30 overseas country approved new drugs. This list mainly refers to new drugs for the treatment of rare diseases and for the prevention and treatment of diseases that seriously endanger life or seriously affect quality of life, which have been existingly approved by US FDA, the European…