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China Tightens Controls Over Blood-based Medicines

China's drug watchdog has tightened controls on blood-based medicines by ordering that, from June 1, every batch of human immunoglobulin must be checked and approved before entering the market.


The regulation will be extended to all blood-based drugs from Jan. 1, 2008, according to the State Food and Drug Administration (SFDA).


Supervisors will carry out spot checks on the premises of the blood drug producers.


They will be trained for the mission by local drug watchdogs.


More than 80 supervisors from the SFDA had been sent to 33 blood-based drug producers and 31 vaccine producers in 24 provinces, autonomous regions and municipalities by the end of March.


Earlier this year, Guangdong Bioyee Pharmaceutical Co. Ltd, a human immunoglobulin producer, was convicted of violating production rules and had its manufacturing certificate revoked.


The company's blood-based drug was sold in 12 regions including Beijing, Shanghai, Fujian and Shandong. At least 90,000 doses of the drug have been recalled, according to the SFDA.


(Xinhua News Agency May 19, 2007)

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