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New Drug GMP to Emphasize the Human Factor

Jan. 31, 2010

The latest version of Good Manufacturing Practice (GMP) requirements for drugs will be released by the State Food and Drug Administration (SFDA) in the first quarter of 2010.
While previous GMP requirements emphasized infrastructure, the updated version is focusing on management and personnel abilities, as well as post-market surveillance of products. It is estimated that manufacturers may have to invest an average RMB 20-30 million to comply with the new GMP requirements.