Tags: | NMPA | Pharmaceuticals | Drug | 药监局 | 医药品 | 药品 |
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
Class 5-1: Imported Innovative Drugs which have been marketed outside China, apply china domestic market approval.
Class 5-2: Imported Generic Drugs which have been marketed outside China, apply china domestic market approval.