Tags: | NMPA | Pharmaceuticals | Drug | 药监局 | 医药品 | 药品 |

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)