| 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 |