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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