Chinese FDA To Begin New Blood Products Policy To Prevent Spread Of HIV

Armen Hareyan's picture

China's State Food and Drug Administrationrecently announced that on Jan. 1, 2008, it will begin a new policyunder which all blood products in the country will be screened for HIVand 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'sefforts to monitor the country's blood collection centers, according toa report released earlier this month by New York-based Asia Catalyst.Blood selling practices during the 1990s in China's central Henanprovince contributed to the spread of HIV, which, according to someadvocates, affected about one million people. The situation in Henanled officials to pledge reform, and the health ministry has said thatit maintains stringent supervision of blood collection centers in thecountry. According to the ministry of health, it closed about 150illegal collection and supply agencies nationwide in 2004, the lastyear for which official figures are available. The health ministry inJuly also orderedall blood collection centers in the country to install video cameras toensure that medical staff members are following regulations. Despitethe health ministry's efforts, SFDA in June discovered fake plasmabeing 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 biologicalproducts be tested, according to Yan Jiangying, spokesperson for SFDA.Yan said that the tests also will be required for all vaccines and mostbiological products. Samples "from every batch of blood products willbe 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 protectedwith stricter supervision."

The policy also will require a90-day quarantine period for blood plasma, which is used to create someblood products, Yan said, adding that only plasma that has been testedand cleared during the quarantine period can be used to make bloodproducts. China previously has not had a blood plasma quarantinepolicy, and officials "hope this new measure can help us to root outpossible virus contained in the blood, such as HIV," Yan said. SFDAalso will continue to send inspectors to the country's 33 blood productmanufacturers and 33 vaccine manufacturers in an effort to bolster thesupervision and quality of such products (Xinhua/People's Daily, 9/12).

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