| Classification |
Clinical trial in China |
Application process |
Monitoring period |
|
Class 1: Innovative new drugs which have never been marketed within or outside China, |
Phase I, II and III Clinical trial |
New drug
process |
5 years |
Class 2: Improved new drugs which have never been marketed within or outside China |
Phase I, II and III Clinical trial |
New drug
process |
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 |
Pharmacokinetics (PK) and Phase III Clinical trial |
Domestic Generic
drug
process |
0 year |
Class 4: Domestic Drugs which imitate innovative drugs that have been marketed within China |
Bioequivalence (BE) study |
Domestic Generic
drug
process |
0 year |
Class 5-1: Imported Innovative Drugs which have been marketed outside China, apply china domestic market approval. |
Pharmacokinetics (PK) and Phase III Clinical trial |
Imported innovative drug
process |
0 year |
|
Class 5-2: Imported Generic Drugs which have been marketed outside China, apply china domestic market approval. |
Bioequivalence (BE) study |
Imported generic drug
process |
0 year |
