China clinical trial requirements for chemical drug CFDA registration ( 2016 version)

Class 1: Innovative new drugs which have never been marketed within or outside China,

5 years

Class 2: Improved new drugs which have never been marketed within or outside China

2.1- 3 years
2.2- 4 years
2.3- 4 years
2.4- 3 years

Class 3: Domestic Drugs which imitate innovative drugs that have not been marketed within China but have been marketed outside of China

0 year

Class 4: Domestic Drugs which imitate innovative drugs that have been marketed within China

0 year

Class 5-1: Imported Innovative Drugs which have been marketed outside China, apply china domestic market approval.

0 year

Class 5-2: Imported Generic Drugs which have been marketed outside China, apply china domestic market approval.