China adverse drug event reports rise 5.3% in 2015 in healthy signal


China FDA released its annual adverse drug event monitoring review that showed a 5.3% increase in cases reported in 2015 in what the regulator hailed as a healthy signal of growing public awareness.

The regulator said that in 2015, 1.398 million adverse drug reaction/event case reports were filed to the national adverse drug reaction monitoring network with 393,000 cases being new and serious, accounting for 28.2% of the total.

"New and serious adverse drug reaction/event reporting ratio continues to increase, (and the) the overall display of adverse drug reaction reporting quality and availability continued to improve," the China FDA report said.


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A breakdown of any related illness figures was not immediately available, but a Chinese-language version of the report did detail therapeutic areas and note areas of concern.

The breadth of national reach for reports was said to hit 96.6% at the county level with 1,044 cases reported per million people on average and medical institutions as the main source of data, according to the report.

The report follows the May release of the China FDA tally of adverse event reporting for medical devices that found more than 320,000 incidents were noted in 2015 with 80% from users of medical equipment.

A separate report linked 184 deaths to incidents involving devices.

- here's the Chinese-language release from China FDA
- here's the English-language release from China FDA
- for the full report (Chinese language)

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China FDA logs more than 320,000 device adverse medical reports in 2015

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