CFDA inspection of foreign drug manufacturing enterprises: 2014 update

18 May 2014

Since 2011, the China Food and Drug Administration (the "CFDA", formerly known as the SFDA) has conducted inspections of foreign drug manufacturing sites producing drugs for import into China.

The CFDA announced its plan to conduct inspections of 25 foreign manufacturing sites including those of AstraZeneca, Roche Pharma, 3M Drug Delivery, Dr Reddy's, Abbott Biologicals and Samyang Corporation in 2014.

In December 2013, the CFDA suspended the import of Pfizer's Diflucan following inspection of Pfizer's production facility in Amboise, France. The CFDA cited as the reason for the suspension Pfizer's failure to provide in time a "supplementary application" required under the Chinese regulation and stated that the suspension would remain in effect until this was rectified. In the same month, the CFDA banned the importation of an antibiotic injection produced by Daewoong Pharmaceutical due to the company's refusal to allow on-site inspection.

The CFDA overseas inspections have been carried out even though the Foreign Drug Manufacturing Enterprises Inspection Administrative Measures (the "Measures") have yet to be formally implemented. The Measures, first published in August 2012 set out, amongst other things, the inspection procedure, the review of drug registration submission materials and on-site materials.

The inspection of overseas drug manufacturer sites by regulators is not new. The US Food and Drug Administration (FDA) have been conducting inspections in China for many years and there is a team of FDA inspectors based in China overseeing Chinese manufacturers of drug products destined for the US market.

The recent CFDA announcement of these inspections demonstrates China's commitment to ensuring imported drugs comply with China's Good Manufacturing Practices ("GMP") standards.  The CFDA has made clear that "any violation of Chinese regulations found during CFDA's onsite inspection will lead to severe measures including public warning, import suspension and sales suspension in China". It is clears that overseas drug manufacturers will see an increase in inspection requests by the CFDA in years to come and this is likely to be well before the Measures are implemented.


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Caroline Wong

China and Hong Kong

Call me on: +852 2248 6000