The China paradox: as its CRO base grows, recent deaths show urgent need for GMP controls

China continues to become a more important force in the global market, especially in the contract research area, as PME News reported recently in an article written by Bioplan Associates' Guangzhou-based project director Yibing Zhou.  China is building up a regulatory framework, "on the fly" as it develops this contract research capability. However, there's a great deal of spadework that needs to be done first, to ensure the safety of the nation's own pharmaceutical supply, as well as its contract manufacturing base. This week brought news from China, and the deaths of nine people who received injections of a drug made with the toxic chemical diglycol, rather than propylene glycol. Apparently quality officials at the drug manufacturing facility in Northeast Heilongjiang Province did not realize that they'd been sold the wrong material. This is certainly not the first such incident in China, where drug counterfeiting has become a cottage industry.  But could it be China's equivalent to the "sulfonamide tragedy" in the U.S., that led to the establishment of stricter U.S. laws and a more powerful FDA? In the wake of this tragedy, the Chinese government has launched an investigation of the nation's drug manufacturing facilities. -AMS