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)