The registration classification of chemical drugs is divided into the following five categories:

1. Innovative drugs that are not marketed both domestically and abroad

These drugs (API and its preparation) contain new compounds with clear structures and pharmacological effects and they have clinical value.

2. Modified new drugs that are not marketed both domestically and abroad

2.1 The drugs (API and its preparation) obtained by split or synthetic methods, etc. and contains optical isomer with known active ingredients, or forming aster from known active ingredients, or forming salt from known active ingredients (including salt contain hydrogen bond or coordination bond). Or change the acid radical, base or metallie element of known active ingredients, or forming other non-covalent of derivatives (such as complexes, chelates, or inclusion complexes) and has significant clinical value.

2.2 These drugs (API and its preparation) contain new dosage forms with known active ingredients (including new administration system). New formulation process, new route of administration and the preparation has significant clinical value.

2.3 The new compound preparation contains known active ingredients and has significant clinical value.

2.4 The preparation contains new indications with known active ingredients.

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

This kind of drugs (API and its preparation) are supposed to have same active ingredient, dosage form, strength, indications, dosage and route of administration with original drugs.

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

This kind of drugs (API and its preparation) are supposed to have same active ingredient, dosage form, strength, indications, dosage and route of administration with original drugs.

5. The drugs that have been marketed abroad are applied to be marketed domestically

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

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