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On 17 January 2011, the Ministry of Health promulgated the Good Manufacturing Practice for Pharmaceutical Products (2010 version) (2010 GMP) , which raised the threshold for the first time since 1999 for drug manufacturers to qualify for Good Manufacturing Practice (GMP) certification.

As the government body charged with supervising and enforcing the standards set out in the 2010 GMP, the State Food and Drug Administration (SFDA) released the Management Measures for Good Manufacturing Practices (GMP) Certification for Pharmaceutical Products with effect from 2 August 2011 (2011 GMP Management Measures). The 2011 GMP Management Measures supersede the Management Measures for GMP Certification for Pharmaceutical Products issued on 7 September 2005 (2005 GMP Certification Measures) .

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