Kim Gang-rip: "Cancellation of Botox Product Approvals Including Hugel Was a Necessary Measure"

[Asia Economy Reporter Lee Chun-hee] Kim Kang-lip, Commissioner of the Ministry of Food and Drug Safety (MFDS), emphasized the legitimacy of the regulatory actions taken against domestic botulinum toxin manufacturers for violating national batch release approval requirements, calling them "appropriate and necessary measures."

At a press briefing held on the 17th at the MFDS office in Osong, Chungbuk, Commissioner Kim explained that the initiation of product license cancellation procedures against Hugel and PharmaResearch Bio for selling botulinum toxin products without national batch release approval was "an appropriate and necessary measure" and "an action in accordance with current laws and regulations."

Earlier, on the 10th, the MFDS announced that the Central Investigation Unit for Violations had uncovered that Hugel and PharmaResearch Bio sold six botulinum toxin products domestically without obtaining national batch release approval. Consequently, administrative actions including product license cancellations and recall and disposal procedures were initiated. Notably, in the case of PharmaResearch, it was revealed that export-only pharmaceuticals were sold domestically without approval for domestic sales, and a six-month suspension of all manufacturing operations is expected.

Currently, for biological products requiring special attention in terms of health and hygiene, safety and efficacy must be ensured through the MFDS Commissioner's review of manufacturing and quality control data and testing before domestic sales, with batch release approval required for each manufacturing unit. Additionally, export-only pharmaceuticals, which are approved under conditions that prohibit domestic sales and require manufacturers to produce according to importers' specifications solely for export, are banned from domestic sales.

However, Hugel immediately strongly opposed this. They argued that the products in question are "export-only products" that are shipped overseas directly through domestic trading companies and thus are not subject to national batch release approval. Hugel filed an administrative lawsuit to cancel the product license revocation and requested a suspension of enforcement. Hugel claims that the MFDS suddenly challenged distribution practices that had not been problematic until now.

Commissioner Kim responded, "Although multiple companies claim that their actions were based on established practices and unaware of the reality, if necessary, the court will make a judgment on this matter," reiterating that the measures taken are "understood as actions in accordance with current laws and regulations."