Chinese Food and Drug Administration Next Year To Begin New Blood Products Policy To Prevent Spread of HIV
China's State Food and Drug Administration recently announced that on Jan. 1, 2008, it will begin a new policy under which all blood products in the country will be screened for HIV and other bloodborne diseases and approved before entering the market, Xinhua/People's Daily reports (Xinhua/People's Daily, 9/12).
China's blood supply has not been monitored properly for HIV despite the Ministry of Health's efforts to monitor the country's blood collection centers, according to a report released earlier this month by New York-based Asia Catalyst. Blood selling practices during the 1990s in China's central Henan province contributed to the spread of HIV, which, according to some advocates, affected about one million people. The situation in Henan led officials to pledge reform, and the health ministry has said that it maintains stringent supervision of blood collection centers in the country. According to the ministry of health, it closed about 150 illegal collection and supply agencies nationwide in 2004, the last year for which official figures are available. The health ministry in July also ordered all blood collection centers in the country to install video cameras to ensure that medical staff members are following regulations. Despite the health ministry's efforts, SFDA in June discovered fake plasma being used in at least 18 hospitals in northeastern China (Kaiser Daily HIV/AIDS Report, 9/7).
Under the new policy, blood products will be tested by the National Institute for the Control of Pharmaceutical and Biological Products in Beijing, Xinhua/People's Daily reports. The previous policy required that only parts of blood and biological products be tested, according to Yan Jiangying, spokesperson for SFDA. Yan said that the tests also will be required for all vaccines and most biological products. Samples "from every batch of blood products will be sent to the NICPBP before sale or import," Yan said, adding that it "will take longer to approve the blood products production and sale, but it is worthwhile since people's life safety can be better protected with stricter supervision."
The policy also will require a 90-day quarantine period for blood plasma, which is used to create some blood products, Yan said, adding that only plasma that has been tested and cleared during the quarantine period can be used to make blood products. China previously has not had a blood plasma quarantine policy, and officials "hope this new measure can help us to root out possible virus contained in the blood, such as HIV," Yan said. SFDA also will continue to send inspectors to the country's 33 blood product manufacturers and 33 vaccine manufacturers in an effort to bolster the supervision and quality of such products (Xinhua/People's Daily, 9/12).