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China to Enhance Adverse Drug Reaction Monitoring
China plans to enhance the surveillance of adverse drug reactions (ADR) by improving the monitoring system nationwide and urging pharmaceutical enterprises, drug stores and hospitals to report ADR cases.
A government regulation asking for strict procedures for ADR monitoring has been in effect since late last year. "Further implementation of the order and education for the general public are needed at present," said Wang Xiaoling, a staff member at the National Center for ADR Monitoring.
Although the national center opened in 1989, only 12 of the total 31 Chinese provinces have established branch centers so far, Wang said, adding that the other provinces will have to set up centers eventually.
Pharmaceutical enterprises, Chinese agents of foreign medicines, drug retailers, hospitals and other medical institutions are responsible for collecting and reporting ADR cases, according to the order.
Drug consumers can also report ADR cases to local monitoring centers and drug administrations. Wang Xiaoling noted that the reports from consumers would be an important source of ADR discovery, as more and more over-the-counter drugs are available in the country.
For any new medicine with a marketing period of not longer than five years, any ADR cases, whether alleged or confirmed, will have to be reported. Reporting of severe, rare or new ADR cases of old drugs is also mandatory.
The State Drug Administration will publish the report on ADR monitoring randomly to keep the public on the alert, Wang said.
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