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China’s New Drug GMP: Higher Standard, New Compliance Philosophy

The Food and Drug Law Institute
November/December 2011

China’s major new drug Good Manufacturing Practices regulations (GMP 2010) took effect on March 1, 2011. Multinational companies can no longer rely solely upon compliance with U.S. or EU GMP regulations, and will need to review current procedures in China.

This article has been reprinted with the permission of FDLI.