The US FDA told us that China has “taken longer than FDA had hoped” in approving the visas of new FDA inspectors that would more than double the agency's presence in China.
The delay comes as the US Food and Drug Administration (FDA), which currently has a team of eight inspectors in China, asked the Chinese government in late 2012 about possibly adding 20 more employees on the ground there.
“Working with the US Department of State, FDA has engaged China’s Ministry of Foreign Affairs regarding the details of these efforts,” FDA spokesman Stephen King told In-Pharmatechnologist.com. “The Chinese Ministry of Foreign Affairs has undertaken an extensive, government-wide process to review FDA's plans.”
But King said the agency remains optimistic that China will allow the new inspectors. “We trust that our two governments will soon be able to come to final agreement on this issue,” King said.
The call for more inspectors was also included in the continuing resolution, which included an increase of $10m to expand the US agency’s capacities in China. But those plans had included calls for 16 more inspectors in China and three US-based China analysts.
The FDA also has plans to increase resources to inspect clinical trial sites, conduct follow-up inspections and engage with Chinese regulatory authorities more frequently.
“We continue to emphasize the importance of posting more FDA staff to China,” King added.
According to Pharmalot , which first reported these latest FDA frustrations, the agency so far has only been able to send inspectors who are permitted to make short-term trips to conduct inspections. One FDA staffer apparently even withdrew his application for a visa last April after waiting nine months for diplomatic approval to work in China.
Similarly, India is also having issues placing inspectors in China to investigate plants, according to the Wall Street Journal’s Live Mint.
The Indian drug industry obtains about 90% of its raw materials from China, but has yet to open an inspection operation there.
Indian drug industry reportedly imported about $4.6bn worth of APIs from China in 2012, up from $2.9bn in 2011.