[Asia Economy Reporter Byeon Seon-jin] The Ministry of Food and Drug Safety announced on the 1st that it has identified three companies that sold botulinum toxin products domestically without obtaining national batch release approval.
The companies and products caught for not obtaining batch release approval are Jetema's 'Jetema Derma Toxin Injection', Korea BMI's 'HiTox Injection', and Korea BNC's 'Bionox Injection'. All of these are export-only pharmaceuticals but were sold domestically.
Botulinum toxin products are biopharmaceuticals mainly used for cosmetic procedures such as glabellar wrinkle improvement. Biological products must obtain national batch release approval from the Ministry of Food and Drug Safety, which reviews manufacturing and quality control before domestic sales.
The Ministry explained that it will proceed with administrative actions such as cancellation of product licenses for the relevant items, as well as recall and disposal procedures. Additionally, the three companies have been ordered to suspend manufacturing operations for six months.
The Ministry of Health and Welfare and the Health Insurance Review and Assessment Service have been requested to inform hospitals and clinics not to use the relevant products. The Ministry also distributed safety alerts to medical professionals such as doctors and pharmacists and requested cooperation to ensure proper product recalls.
The Ministry stated that it will strictly take action against illegal distribution of pharmaceuticals whose quality, safety, and efficacy have not been confirmed, and will continuously guide the industry to comply with laws and regulations.
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