Shanghai Food and Drug Administration Issues Regulation for Domestic Processing and Manufacturing of Foreign Pharmaceutical Companies


McDermott Will & Emery has a strategic alliance with MWE China Law Offices, a separate law firm based in Shanghai. This China Law Alert was authored by MWE China Law Offices lawyers Henry (Litong) Chen and Michael Xu.

Following the State Food and Drug Administration (FDA)’s notice,“Enhancing Regulations for Domestic Processing and Manufacturing for Foreign Pharmaceutical Companies” (translation available upon request), the Shanghai FDA enacted its own regulations for Shanghai contract manufacturers of foreign pharmaceutical companies to ensure pharmaceuticals that are contract manufactured in China meet the drug standards of the United States.This is a cross-border regulatory cooperation between Chinese and American governmental authorities. Concerned U.S. companies are encouraged to read through and leverage the regulations that would be beneficial to them.

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