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Regulatory Focus™ > News Articles > China Implements Revised Good Quality Control Standards for Drugs

China Implements Revised Good Quality Control Standards for Drugs

Posted 01 July 2013 | By Ansis Helmanis

The China Food and Drug Administration (CFDA) has announced that as of 1 July 2013, new start-up pharmaceutical companies must comply with the requirements of the revised Drug Quality Control Standards for obtaining a qualifying Drug License certificate and Drug Good Manufacturing Practice (GMP) certificate.

The requirements will also apply to warehouses and pharmaceutical enterprises that apply for certification of new, renovated or expanded business premises.

Companies that cannot complete the transition to the revised standards by 31 December 2013 can apply for an extension until 30 June 2014 or later.  The 1 July deadline also applies to wholesale businesses dealing with vaccines, narcotic and psychotropic substances, anabolic agents and peptide hormones as to acceptable storage and distribution requirements.  If a company does not meet the revised requirements by 31 December 2015, it may no longer continue to engage in drug business activities.

CFDA Announcement

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Tags: GMP

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