China institutes first-ever drug recall policy

BEIJING, China China began on Wednesday a nationwide recall system that makes companies responsible for recalling harmful drugs, according to published reports. The move came a day after U.S. and Chinese officials signed an agreement on the safety of medicine and medical devices.

Under the new law, companies must establish systems to recall harmful drugs within a set time period and alert the government of any noticeable negative reactions to the drugs among patients.

The new recall rule puts the responsibility on companies to have such systems in place. Each drug will be recalled within different timeframes, ranging from 24 hours for the most serious drugs to 72 hours for those deemed less life-threatening.

They are also encouraged to carry out voluntary recalls and may escape legal punishment if they do. Drug distributors and medical institutes must also notify authorities of any safety risk to a particular drug.

Unlike the United States’ policy of voluntary drug recalls by companies, the Chinese government can also order a compulsory recall of bad drugs. A fine of three times the total value of the recalled drugs will also be levied on any company that did not voluntarily recall a bad drug.

“We hope that government and companies can cooperate to enhance and perfect the establishment of the system and not just rely on the government’s information. The companies should make efforts to monitor drug reactions,” State Food and Drug Administration deputy director Yan Jiangying said.

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