[Asia Economy Reporter Moon Hyewon] The Ministry of Food and Drug Safety announced on the 22nd that it has suspended the sales of Medytox's botulinum toxin product 'Innotox Injection' and canceled its product approval.
This action follows the results of a prosecution investigation into allegations of document forgery related to the approval submission of Innotox Injection, which was reported as a public interest whistleblowing case to the Anti-Corruption and Civil Rights Commission.
The prosecution confirmed that Medytox forged safety test data required for drug approval and indicted the company for "obstruction of official duties by deception" under Article 137 of the Criminal Act.
The Ministry of Food and Drug Safety received notification of the criminal facts from the prosecution and verified the violations.
As a result, it was determined that the case falls under Article 76 of the Pharmaceutical Affairs Act, which pertains to "cases where a company obtains product approval or approval for changes through false or other unfair means," and initiated the product approval cancellation procedure.
The Ministry ordered a provisional suspension of manufacturing and sales to protect consumers and prevent potential harm.
Additionally, safety alerts were distributed to medical professionals, the Health Insurance Review and Assessment Service, and related organizations, requesting immediate cessation of use.
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