Thursday, August 22, 2013

Visa Delays Complicating FDA Inspections

US efforts to increase the monitoring of Chinese drug production are being held back by China's refusal to grant visas in any kind of timely fashion.  Since receiving an extra $10m in funding, the FDA has been able to send more inspectors to China, or they would be able to if any diplomatic visas had been granted.  One inspector reportedly withdrew his application after waiting an epic 9 months for his visa.

The FDA wants to add another 10 members of staff to it's China operation, but the reluctance to issue visas by the Chinese embassy has limited visits by FDA staff to short term trips.
“Unlike the inspectors who come for short-term trips from the US, they’re able to develop in-depth knowledge of the Chinese system, which not only benefits American consumers and patients, but also Chinese regulators, who benefit from the training and capacity building that FDA’s in-country staff do,” the FDA spokesman writes us.

“And they’re able to participate in our ongoing efforts to better understand the Chinese regulatory system, so that we can better protect American consumers, and promote public health. We believe that timely issuance of visas for FDA staff will be beneficial to both the US and China, and that it’s in China’s best interest to issue these visas, and move on to our next stage of collaboration"

The FDA is keen to ramp up it's monitoring after the tainted heparin scandal in the country that was linked to 81 deaths in the States.
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