Life Sciences partner Katherine Wang (Shanghai) was quoted in a July 28 PharmAsia News and The Pink Sheet article on the release of the China Food and Drug Administration’s (CFDA) new draft Drug Registration Regulation (DRR) in the world’s second largest pharmaceutical market.
Ms. Wang explains that the DRR omission of review time limits could provide the CFDA with flexibility to focus on new drug reviews. The omission of a framework for multi-regional clinical trials (MRCTs) indicates that the CFDA sees only one regulatory pathway for drug product approval in China. While companies can still conduct MRCTs including China sites, they will have to seek normal local approval, which could make the start of a global parallel study harder to predict.
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