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Regulatory Focus™ > News Articles > Corrected: CFDA Issues API Export Instructions to Provinces

Corrected: CFDA Issues API Export Instructions to Provinces

Posted 15 May 2013 | By Louise Zornoza

China's Food and Drug Administration (CFDA) last week issued instructions to Chinese provinces regarding the requirements for certifying active pharmaceutical ingredient manufacturers for the right to export their products to the European Union (EU) as of 2 July 2013.

Editor's Note: A previous iteration of this article said that the ingredients in question were excipients. They are in fact APIs. We regret the error.

The announcement, made on 7 May 2013 and issued with accompanying forms, requires provincial food and drug supervision and management departments to identify officials familiar with pharmaceutical good manufacturing practice (GMP) supervision and with a basic command of English by 20 May 2013. These officials will oversee the local export certification process, CFDA said.

If a company has not already obtained a production license for bulk drugs, its facilities must undergo and pass a GMP on-site inspection as well as meet the additional certification requirements. If a site does not comply with the current GMP requirements or does not comply with the conditions for certification, local authorities must inform CFDA within 24 hours so that the information can be forwarded to the EU.

By Louise Zornoza, RegLink News

Read all Breaking News from RegLink


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Tags: Export, Excipient, EU

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