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CFDA notice on new chemical drug classification standard on registration price

The notification for reform of chemical drug classification has reclassified the chemical drug, Afterward, CFDA publishes the new classification of registration standard of chemical drug. The main aspects are:


1. The registration price for chemical drug category 1 and 2 follows the new drug registration price. The registration price for chemical drug category 3 and 4 follows generic drug registration price. Domestic and overboard drug followed the two standards respectively.


2. The registration price for chemical drug category 5 follows the imported drug requires or does not requires clinical trials.


For more detailed information, please refer to Chinese version website of CFDA: http://www.sda.gov.cn/WS01/CL0087/164024.html


SOURCE:CFDA

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