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

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
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