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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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