Reducing the backlog of drug registration radically is good for some enterprises
2015-08-28
At night of July 31st, 2015, CFDA released an “Announcement about soliciting opinions on policies of reducing the backlog of drug application registration” (No.140, 2015) (hereinafter referred to as “Soliciting opinions”
After CFDA released an “Announcement about self-checking drug clinical trial data” on July, 22nd, they take a second movement on revolution of drug registration. According to “Soliciting opinions”, on the one hand CFDA will actively support R & D and application of innovative drug, children’s drug, clinical urgent need and shorted drug, and rob imitation drugs, on the other hand they will no longer tolerate on drugs with problems of safety, effectiveness, and quality.
It will not work to change preparation or acid root.
The drug with clinical value or urgent needed is in priority.
Fight for resource with high quality will be more violent.