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China to Begin Compulsory Blood Products Tests

China will begin compulsory testing on every batch of blood products from January 1, 2008, as one of its latest moves to tighten supervision of blood and biological products, according to the State Food and Drug Administration (SFDA).

"Every batch of blood products must pass the compulsory test before being put on the market or being imported," said SFDA spokeswoman Yan Jiangying Tuesday.

The blood samples will tested by the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP) in Beijing.

"In the future, samples from every batch of blood products will be sent to the NICPBP before sale or import," Yan said, noting "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."

China has strengthened supervision of pharmaceutical and biological products this year. In July, the SFDA revoked the production license of Guangdong Baiyi Pharmaceutical Company after it made a blood product from an infected donor. The antibodies of some patients injected with the blood tested positive for hepatitis C.

In the past, only part of blood and biological products are required to take the compulsory test, according to Yan.

Since the end of 2002, China has adopted state compulsory test for every batch of human albumin; Since January, 2006, China has applied the compulsory test for all vaccine products used for disease prevention; Since June, 2007, China has required all human immunoglobulin to take the compulsory test.

Yan said from next year, the compulsory test will be expanded to all blood products, all vaccine used for disease prevention and most biological products.

Besides the test, another important measure taken by the Chinese government is to set quarantine period for blood plasma used as the materials for blood products next year.

"All the blood plasma used to make blood product must pass test 90 days after blood plasma is collected," Yan Jiangying, spokeswoman of the State Food and Drug Administration.

"From July 1, 2008, only the blood plasma, tested qualified after the 90 days' quarantine period, can be made into blood product," Yan stressed.

"There was no such quarantine period in China and we hope this new measure can help us to root out possible virus contained in the blood such as HIV," she said.

In addition, SFDA will continue to send inspectors to China's 33 blood products manufacturers and 33 vaccine manufacturers to strengthen supervision of the quality of blood and biological products.

Since March 31, SFDA has begun to send inspectors to the 66 manufacturers to strengthen supervision of blood and biological products.

(Xinhua News Agency September 13, 2007)

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