Pharmaceutical Companies of 'Botulinum Toxin Products' Oppose MFDS Sanctions... Why?

Zetema·Hanguk BNC "Unfair"

[Asia Economy Reporter Byun Seon-jin] The Ministry of Food and Drug Safety (MFDS) has detected three companies that sold botulinum toxin products domestically without obtaining national batch release approval and has initiated administrative disciplinary procedures. Among these companies, two have filed objections, claiming the actions are unfair.

MFDS: "Three Bio Companies Sold Products Domestically Illegally and Improperly Without National Batch Release Approval"

The MFDS announced on the 1st that it has started the process of canceling product licenses and recalling and disposing of three products?Jetema's 'Jetema Derma Toxin Injection', Korea BMI's 'HiTox Injection', and Korea BNC's 'Bionox Injection'?for not having obtained batch release approval. Botulinum toxin products are biopharmaceuticals mainly used for cosmetic procedures such as glabellar wrinkle improvement. Biological products must receive national batch release approval from the MFDS, which reviews manufacturing and quality control before domestic sales.

However, according to the MFDS, the products produced by the three pharmaceutical companies were all designated for export only but were illegally and improperly sold domestically. In response, the MFDS explained that it decided to suspend all manufacturing operations of these three companies for six months. The MFDS stated it will strictly take action against the illegal distribution of pharmaceuticals whose quality, safety, and efficacy have not been verified and will continue to guide the industry to comply with laws and regulations.

Additionally, the MFDS requested the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service to advise hospitals and clinics not to use the products in question. The MFDS also distributed safety alerts to medical professionals such as doctors and pharmacists and requested cooperation to ensure proper product recalls.

Two Companies Immediately Protest "Unfair"

However, Jetema and Korea BNC immediately protested, stating, "There was no domestic sale of the products, so there was no need to obtain national batch release approval." The two companies speculate that the reason for the administrative sanctions is that the MFDS regarded 'indirect export' as domestic sales. Indirect export mainly involves handing over goods to domestic exporters who then export them overseas, a structure that is simpler than direct export by pharmaceutical companies, which is why it is used.

Jetema stated in a position posted on its website, "We have never distributed or sold the products domestically and have secured and submitted all related documents to the MFDS, yet unfair sanctions were imposed." It added, "We will immediately file objections, request provisional suspension of the sanctions, seek suspension of execution, and initiate administrative litigation." Jetema also claimed that according to the Pharmaceutical Affairs Act, pharmaceuticals produced and exported for export purposes are not subject to the MFDS's national batch release approval, citing a Supreme Court ruling. Korea BNC also said, "Most domestic companies manufacturing and selling botulinum toxin products have long sold export-only pharmaceuticals without national batch release approval," and "we will file objections, request suspension of execution, and initiate cancellation lawsuits against this sanction."

The number of companies sanctioned by the MFDS for not obtaining national batch release approval for export-only botulinum toxin products has reached six, following Medytox (2020), Hugel, and PharmaResearch Bio (2021). Medytox, PharmaResearch Bio, and Hugel are currently involved in lawsuits contesting the cancellation of their product licenses.

This content was produced with the assistance of AI translation services.