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Ministry to request investigation into Meditoxin approval process
  • By Lee Hye-seon
  • Published 2019.07.12 16:29
  • Updated 2019.07.15 17:11
  • comments 0

The Ministry of Food and Drug Safety denied a suspicion that the ministry poorly monitored the quality control of Meditoxin, a botulinum toxin product by Medytox.

The ministry will ask an investigation agency to probe the case to resolve the suspicion that the key decision-maker in the Meditoxin approval process was either a shareholder of Medytox or a person associated with the shareholder, it said.

“We are investigating on the suspicion over Meditoxin injections. We also plan to check if the drug was manufactured under the latest safety management system,” the food and drug safety ministry said in a statement Friday.

In response to criticism that the ministry has been negligent on the inspection of the Meditoxin manufacturing site, it said, “We are regularly checking on the manufacturing site. We collected products in distribution and tested them in 2014, 2016, and 2018, and all were qualified.”

“To resolve the suspicion over a shareholder of Medytox fairly and objectively, we will request an investigation agency to look into the matter,” the ministry said.

lhs@docdocdoc.co.kr

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