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CFDA Promises to Ease Rules for Approving Novel Foreign Drugs

publication date: Aug 18, 2015

The CFDA promised to ease the regulations governing simultaneous China-global clinical trials of novel drugs and allow more data from global trials in its consideration of innovative products. In addition, the CFDA pledged to wipe out its backlog of more than 20,000 drug approval requests by the end of 2016, according to a Bloomberg article. Foreign drugmakers can ask the agency to speed up the China review process if the drug addresses unmet needs. However, the price for the drug cannot exceed the price charged in the drug's home market or in countries similar to China. More details....

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