US to bolster inspections of China drug production facilities amid safety concerns
Increased export volume spurs enhanced US Food and Drug Administration safety inspections of pharmaceutical production plants in China
The US Food and Drug Administration is increasing its oversight of Chinese manufacturers of pharmaceutical ingredients to improve the safety of the US drug supply chain, the director of the agency’s China office, Christopher Hickey, said on Thursday.
Hickey was one of several witnesses who testified before a hearing of the US-China Economic and Security Review Commission, which monitors and investigates the national security implications of bilateral trade and economic relations between the two countries.
Armed with new legal authority and additional funding, the FDA has begun adding staff and inspectors in China, but the process is not without challenges, Hickey said.
In 2012 the agency began to notice delays in the issuance of Chinese visas, forcing the agency to fly investigators to the country for brief and expensive visits. That situation began easing after US Vice-President Joe Biden visited Beijing in December.
“As the number of medical products coming from China has increased, so have the challenges.”
“We faced delays for many months but I think when the senior levels of the Chinese government were engaged we saw some movement on the issue,” Hickey said.
About 80 per cent of the active ingredients and bulk chemicals used to make pharmaceutical drugs sold in the United States come from overseas. Of those, nearly half are made in China and India.
