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China Proposes Fast-Track Approvals for Innovative Drugs

publication date: Jan 18, 2013
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China’s SFDA is considering far-reaching changes to its drug approval process. The proposals would replace the present system, which considers requests on a first-come, first-serve basis, with a system that prioritizes need. Innovative drug candidates, especially those that address unmet diseases, would be processed under new fast-track procedures. On the other hand, requests for approval of generic drugs that have multiple suppliers would be discouraged. In other words, the SFDA would respond much like the market itself, rather than treating each drugmaker request as equally important. More details....

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