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China’s Pharmaceutical Regulatory System and Collaboration with the U.S. FDA

October 4, 2010

Since 2007, the United States Food and Drug Administration (FDA) has been working more closely with China’s primary medical regulatory authority, the State Food and Drug Administration (SFDA) to increase regulatory control of imported and exported medical goods. Regulatory harmonization deals such as the “Agreement on the Safety of Drugs and Medical Devices” in 2007 have resulted in this increased collaboration between the U.S. and China. In 2008, The U.S. FDA created its own branch agencies in China, to more closely monitor the country’s medical activities. Since then, the U.S. FDA has carried out over 30 inspections of medical facilities in China.

For international companies exporting medical products to China, familiarity with the SFDA’s role and function is a must. However, the SFDA operates differently from organizations that oversee food and drug regulations in the United States and Western Europe.

One key difference is the level at which drug regulatory compliance inspections are carried out. In both China and the United States, there is decentralization of authority within the SFDA and FDA, respectively. The U.S. FDA may have regulatory officials from a local office visit a drug manufacturing facility, but the results of that inspection would be reviewed by the agency’s central authority. In contrast, China’s system allots significantly more autonomy to the provincial SFDAs. China’s provincial SFDAs can operate relatively independently of the national SFDA when it comes to inspections. In other words, if a drug distribution company were to undergo an inspection by a provincial SFDA, then oftentimes that same provincial SFDA would also be the one to review and issue results of the inspection.

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