The Ministry of Food and Drug Safety said it imposed an administrative warning on SCM Lifescience for failing to meet the deadline of reporting adverse reactions during a clinical trial.
According to the ministry’s integrated pharmaceutical information system, the company received the warning as the first reprimand on Wednesday for the “delayed reporting of serious and unexpected adverse drug reactions.”
The ministry’s administrative punishment was based on the Pharmaceutical Affairs Act’s Article 76, Paragraph 1 and 3, and Article 95 of the rules on pharmaceutical products' safety.
Under the government’s regulation on clinical trial management, an institution conducting a study must report any adverse event to the regulator’s Clinical Trial Review Committee within 15 days after discovering such an event during a clinical trial.
Under the rule, a clinical trial conductor failing to comply with the safety rules during a drug test could face a warning for the first violation, suspension of business for 15 days for the second violation, suspension of business for one month for the third, and suspension of business for three months for the fourth.
The ministry did not disclose details of the administrative punishment on SCM Lifescience.
“This is a classified issue. The reprimand resulted from the delayed reporting, not from the drug’s safety issue. If we disclose the product's name, it could mislead the public as if the drug had any safety problem,” a ministry official said.
However, some observers said the regulator should disclose the medicine's name because the punishment was involving “serious and unexpected adverse drug reactions.”
According to Korea Good Clinical Practice, “unexpected adverse drug reaction” refers to a difference in the pattern of adverse drug reactions or the degree of harm in light of the drug's available information in clinical investigators’ data or attached documents.
“Serious adverse event/adverse drug reaction” refers to death or life-threatening situation, a need for hospitalization or extension of hospitalization, permanent or serious disability or function deterioration, a malformation or abnormality in the fetus, or other medically important events such as drug dependence/abuse or a blood disease.
An official at SCM Lifescience refused to comment on the administrative punishment.
<© Korea Biomedical Review, All rights reserved.>