The Ministry of Food and Drug Safety said Friday that it has amended the regulations on dealing with institutes that deliberately deceive or omit clinical trials records.
The amendment aims to improve the sub-regulations of the revised Pharmaceutical Affairs Law in June and to ensure the reliability of clinical trial subjects' safety and its results. It includes a new administrative disposition standard for institutes that falsify clinical trial records, and clarifying the rule for reporting changes in clinical trial plans.
Under the new regulation, clinical trial institutes that make false clinical records will be subject to administrative penalties based on the number and frequency of violations.
Also, agencies that falsify reports intentionally or out of gross negligence will have their license revoked. In other, less grave cases, the suspension will be one month for one violation, three months for two violations, six months for three violations, and designation cancellation for four violations.
Other changes include the removal of an unclear clause on "clinical trial changes mandated by the minister of food and drug safety," which will enhance the predictability of clinical trial participants and shortening the period for non-clinical testing organizations that are trying to change the test field or items from 90 days to 60 days.
“We will establish a thorough manufacturing and distribution management system to supply and distribute excellent pharmaceuticals with proved safety to the public,” a ministry official said. “The agency will also make efforts to build a consumer-oriented legal system environment.”
The ministry has posted the new regulations on its website.
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