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Regulatory Focus™ > News Articles > China Clarifies GMP Compliance Deadline for Vaccines, Injectables

China Clarifies GMP Compliance Deadline for Vaccines, Injectables

Posted 03 January 2014 | By Louise Zornoza

According to a bulletin issued by the China Food and Drug Administration (CFDA) on 31 December 2013, manufacturers of blood products, vaccines and injectable drugs that have not obtained certification of compliance with the revised (2010) good manufacturing practices (GMP) may not market those products as of 1 January 1 2014. 

Companies with facilities that have passed GMP inspection prior to January 1, 2014, may continue to manufacture products, but those products may not be marketed until after the actual certificate of GMP compliance has been issued.  All other manufacturers must first apply for and obtain GMP certification before engaging in the production of these products.

CFDA Bulletin

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Tags: Vaccine, GMP

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