Chemical drug registration category reform work protocol” was released by CFDA by announcement No.51 on March 4, 2016.
The following is the new category:
Registration category | Classification description | Introduction of content |
1 | New drug- not launched at home(in China) and abroad | API and its drug product which contain new compound with exact structure/pharmacologic activity/clinical benefit. |
2 | Modified form of new drug - not launched at home and abroad | API and its drug product which contain optical isomer of known active ingredient produced by resolution or synthesis/ester of known active ingredient/salification of known active ingredient(including salt with hydrogen bond or coordination bond)/change acid radical, basic group or metal element of known salty active ingredient/non covalent bond derivant (for example complex/chelate/clathrate compound), such modification should has significant clinical advantage. |
Drug product of new dosage form(including new drug delivery system)/new formulation process/new route of administration which contain known active ingredient, such modification should has significant clinical advantage. | ||
New compound preparation(contain more than one kinds of active ingredients),and has significant clinical advantage. | ||
Drug product with new indication of known active ingredient. | ||
3 | Imitate drug of originator’s drug which is launched abroad but not launched at home(in China) | API and its drug product which has the same active ingredient, dosage form, strength, indication, route of administration and dosage/administration as the product of originator. |
4 | Imitate drug of originator’s drug which is launched at home(in China)already | API and its drug product which has the same active ingredient, dosage form, strength, indication, route of administration and dosage/administration as the product of originator. |
5 | Apply for import of drugs which is marketing abroad | Application of originator’s drug（including API and its drug product）for marketing in china. |
Application of generic drug(including API and its drug product) for marketing in China. |
