The Ministry of Food and Drug Safety (MFDS) said on July 12 that it plans to ask an investigative agency to investigate allegations that shareholders were the main determinants in the Medytox’s recent clinical passage of Meditoxin.
"We plan to request an investigation for fairness and objectivity since the suspicion regarding Medytox's shareholders is beyond the boundaries of the Pharmaceutical Affairs Act," an MFDS official said.
A media outlet reported on July 11 that a professor surnamed Kim, the head of a clinical research institute at a university hospital, conducted the "Meditoxin" clinic two times in 2003 and 2005, in which Kim's wife was a shareholder of Medytox.
According to the report, Kim's wife previously bought 2,000 shares worth 5,000 won per share, but the shares increased to 40,000 shares in five years after free capital increase and face division. The report also said that Gil, president of the toxicology research institute, a clinical trial and evaluation agency, and Yang, former head of the MFDS, held shares of Medytox under borrowed names.
In addition, the MFDS plans to check whether the drug was manufactured under the latest safety management system for alleged problems with the quality of "Meditoxin."
Earlier, the MFDS began a pharmacological inspection in May and is currently investigating the Medytox's Ochang 1 plant that has been suspected of failing to properly carry out the sterilization work for more than a decade.
If violations of the Pharmaceutical Affairs Act are found during the investigation, administrative measures could be imposed.
