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China ADR Reporting System Improved

China received 165,028 reports of adverse drug reactions (ADR) and events in the first half of 2008, an increase of about 45 percent over the same period a year ago, the country's drug watchdog said on Tuesday.

Among them, 11,179 cases, or 13.5 percent, were reported for the first time or involving severe adverse reactions, Yan Jiangying, State Food and Drug Administration (SFDA) spokeswoman, told a press conference.

In total, 5,835 cases of adverse drug reactions involving medical apparatus were also reported through June, more than eight times as many as that of the same period last year, Yan said.

ADR is an unwanted or negative consequences sometimes associated with the use of medications.

"But the increase is not due to having more ADR events happening this year, but a result of an improvement in China's ADR reporting system," Yan said.

"Nowadays, Chinese people have clearer awareness of ADR and its possible negative consequences. China's ADR events reporting system has been largely improved in many aspects, with a better monitoring network and forewarning system."

Through 2007, a national center for ADR monitoring and 34 provincial-level centers for ADR monitoring have been established on the Chinese mainland.

Yan added the figure for ADR cases in the latter half of the year may surpass that of the first half, citing that 547,000 ADR cases were reported for all of last year with only around 110,000 in the first half of 2007.

In China, the ADR reporting system was set up in 2001 to warn pharmaceutical factories, medical institutions and the society in a timely manner.

Most ADR cases were reported to the SFDA and the National Center for ADR Monitoring through hospitals, but Yan said authorities were also encouraging drug firms to participate in improving drug safety.

(Xinhua News Agency July 9, 2008)


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