The agency is looking to increase its staff in China from eight to 26, more than a year after the agency said the Chinese were taking more time than the FDA hoped to get visas approved for new inspectors.
In fact, the FDA has been trying to add new inspectors to China since 2012. An additional $10m was added to the Continuing Resolution bill in 2013 to add 16 inspectors to China. And earlier this year, the agency’s “favorable” FY 2014 budget included funding to increase inspections in China, though neither of those additions have materialized because of the failure to obtain additional visas.
Commissioner Hamburg, who is visiting China this week to attend the International Summit of Heads of Medicines Regulatory Agencies, said last Friday, “We have every reason to believe that we will be getting the visas very shortly.” And according to the New York Times, Christopher Hickey, director of the FDA’s China operation, said that it had filled the gaps by bringing in experts temporarily.
In addition to adding manufacturing facility inspections, the agency is also looking to inspect the country’s clinical trials, as well as to re-inspect sites that have previously been inspected.
The agency is currently only able to send inspectors on short-term trips to conduct inspections. One inspector even withdrew his application for a visa in April 2013 after waiting nine months for diplomatic approval.
The FDA expects to be performing more than 120 site visits in the country annually beginning in 2016.