Pharma firms deal with clinical trial complexity

A draft guidance on multi-regional clinical trials would make it harder for pharmaceutical companies to get innovative drugs approved in the PRC.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

4 minute read December 05, 2014 at 06:53 AM

clpstaff and clp articles

The China Food and Drug Administration (CFDA)'s draft Guidance on Multi-Regional Clinical Trials (MRCTs) raises the requirements for MRCTs, spurring concern at foreign pharmaceutical companies over potential problems with the launch of new products as well as a lack of procedural guidance.

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