Thursday, December 19, 2013

Vice president clears way for FDA to add inspectors in China Agency will get 10 new drug inspectors to oversee China's massive drug industry December 11, 2013 | By Eric Palmer Read more: Vice president clears way for FDA to add inspectors in China

t took some persuasion from the vice president of the United States, but the FDA will soon add 10 drug inspectors to its office in China to help oversee that country's vast API and drug production industry. If the FDA's experience in India is an indicator, it will mean a raft of enforcement actions in a country that is considered to have weak enforcement by its own agency.
The FDA is adding 19 people to the staff of 9 it already has there, but 9 of those are food inspectors, according to Bloomberg. The FDA opened an office there in 2008 after being hammered for lax oversight when tainted Chinese heparin led to dozens of deaths in the U.S. The FDA has been trying to boost its presence in China for more than a year, but the Chinese government blocked visas of FDA employees assigned there. U.S. Vice President Joe Biden was able to get a final commitment for the expanded FDA presence during a visit to Beijing last week.
"It's a big request for any government to allow an increase in foreign inspectors in your country," Christopher Hickey, director of the FDA's China office, told Bloomberg.


Read more: Vice president clears way for FDA to add inspectors in China - FiercePharma http://www.fiercepharma.com/story/vice-president-clears-way-fda-add-inspectors-china/2013-12-11#ixzz2nvnhgf00
Subscribe at FiercePharma

No comments: