China's State Council Issues Drug Approval Decrees

By 2018, the CFDA must establish a definite limit to drug approval timelines, decreed China's State Council. Within that limit, a drug must be either approved or rejected. The ruling was one of several broad reform initiatives for drug and medical device approval procedures, released by the State Council earlier this week. The major emphasis is on safety and efficacy, especially for the generic products that constitute the majority of the country's drug supply. Now, it's up to the CFDA to establish specific policies that achieve the goals.

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