China to strengthen regulations for excipient manufacturers

05/5/2013 | In-PharmaTechnologist.com

The China Food and Drug Administration has established new licensing requirements for the manufacture of high-risk excipients based on toxicity and dosage. The new rules are part of a broader effort to establish a drug master file system similar to the U.S. FDA's. The capacity of China's FDA to register and inspect pharmaceutical and excipient manufacturers is limited and would benefit from third-party audits and stronger self-policing, according to Meredith Ge, former chairwoman of the International Pharmaceutical Excipients Council, who spoke at IPEC-Americas' Excipient Fest in Baltimore.

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