Bring On Clinical Studies: China Steps Up To Facilitate New Drug Entry
Allowing early stage Phase I studies, setting a 60-day period for IND approvals, and dropping a requirement for hospital to get certified, the China FDA proposes fundamental changes that would allow any qualified sites to file for approval to get studies rolling.
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The China FDA releases a raft of new regulatory proposals outlining fundamental changes in areas including patent linkage and data exclusivity, which look set to profoundly impact decision makers looking at bringing new drugs and devices to the world’s second-largest pharma market.
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