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China Chemical Drug Registration classification regulations

The chemical drugs export to china, divided into six categories, different types of drugs have different CFDA registration procedures, time, cost, application documents requirements.

1   Drugs that are not marketed in Country of origin and China;
(1)    drug substance and its preparation by synthesis or semi-synthesis method;
(2)    new effective monomer and its preparation extracted from natural material or by fermentation;
(3)    optical isomers in known drugs and their preparations produced by resolution or synthesis method;
(4)    fewer-component drugs prepared from marketed multi-component drugs;
(5)    new compound preparation;
(6)    unapproved new indication in home and abroad increased for marketed preparation

2   Administration route changed and un-marketed preparations in Country of origin and China;

3   Drugs that have been marketed in Country of origin but not in china
(1)    preparation and its drug substance marketed abroad, and/or change the formulation of the preparation without changing administration route
(2)    compound preparation marketed abroad, and/or change the formulation of the preparation without changing administration route
(3)    administration route change for preparations marketed abroad
(4)    increasing new indication approved abroad for preparations marketed in home

4   Drug substance and its preparation that change acid radical and base (or metals) of the marketed salts drugs without changing its pharmacological effect

5   Drug Preparations that change the formulation of marketed drugs without changing administration route

6   API or Drug preparation with known china national standards (generic)
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