FDA to Open Inspection Offices in China
Significance: Southern Medicine Economic Research Institute (SMERI) has recently predicted that the Chinese pharmaceutical industry's output will reach over $146 billion in 2009 with the export growth rate likely to reach 25%. The U.S. will remain the top destination of the Chinese manufacturers. However, a series of recent food and drug scandals in China has cast doubt on both Chinese manufacturers' reputations and the FDA's inspection standards. The plan to open new offices will help the FDA to tighten its safety and quality control and to apply its standard of quality to the early stages of production. For the manufacturers, it will reduce the time they need to export to the U.S. market. However, the FDA still needs congress approval to use inspectors outside the organization. This will also pose a new challenge as to how to make sure the outsourcing inspectors strictly abide by FDA inspection standards.
From the October 27, 2008, Prepared Foods e-Flash