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CFDA Proposes New Rules To Guarantee Drug Quality and Speed Up Approvals

publication date: Aug 5, 2015
The China Food and Drug Administration has proposed new drug approval rules that address its two major policy initiatives: safer, more effective drugs and quicker approvals for innovative drugs aimed at unmet needs. Among other requirements, the new rules will require generic drugmakers to prove efficacy equivalence, and several of the provisions are aimed at reducing the number of generic drug applications, according to a Sidley Austin review of the proposed changes. More details....

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