Pharma firms deal with clinical trial complexity

December 05, 2014 | BY

clpstaff &clp articles

A draft guidance on multi-regional clinical trials would make it harder for pharmaceutical companies to get innovative drugs approved in the PRC. If implemented, the new rules could lead to confusion and delays

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The China Food and Drug Administration (CFDA)'s draftGuidance on Multi-Regional Clinical Trials (MRCTs) raises the requirements for MRCTs, spurring concern at foreign pharmaceutical companies over potential problems with the