1

Innovative drugs that are not marketed both domestically and abroad

Phase I, Il and Ill Clinical trial

New drug

5 years

2

Modified new drugs that are not marketed both domestically and abroad

Phase I, Il and Ill Clinical trial

New drug

2.1: 3 years

2.2: 4 years

2.3: 4 years

2.4: 3 years

3

The drugs that are imitated by domestic applications to original drugs that have been marteted abroad but not domestically

Pharmacokinetics (PK) and Phase Ill Clinical trial

Domestic generic drug

0 year

4

The drugs that are imitated by domestic applicants to original drugs that have been marketed domestically

Bioequivalence (BE) study

Domestic generic drug

0 year

5.1

Original drugs (including API and its preparation) that have been marketed abroad are applied to be marketed domestically

Pharmacokinetics (PK) and Phase Ill Clinical trial

Imported innovative drug

0 year

5.2

Non-original drugs (including API and its preparation) that have been marketed abroad are applied to be marketed domestically

Bioequivalence (BE) study

Imported generic drug

0 year