MFDS Takes Strong Action to Revoke Product Approval of Hugel and PharmaResearch for Selling Botox Without Authorization

Decision to Cancel Approval for Six Botulinum Toxin Products

Food and Drug Safety Ministry CI (Photo by Food and Drug Safety Ministry)

[Asia Economy Reporter Lee Chun-hee] The Ministry of Food and Drug Safety (MFDS) has decided to revoke the approval of six botulinum toxin products from Hugel and Pharmaresearch Bio.

The MFDS announced on the 2nd that it will cancel the product approvals for six botulinum toxin products sold domestically by the two companies without obtaining national batch release approval, effective on the 13th. In particular, Pharmaresearch is expected to face a six-month suspension of all manufacturing operations after it was revealed that the company sold export-only drugs domestically without approval for domestic sales.

Earlier, on the 10th of last month, the MFDS stated that the Central Investigation Unit for Violations had detected that the two companies sold botulinum toxin products domestically without national batch release approval, and had initiated administrative actions including product approval cancellations and recall and disposal procedures for the relevant products.

The products subject to approval cancellation are ▲Botulax Injection, Botulax Injection 50 units, Botulax Injection 150 units, Botulax Injection 200 units (Hugel), and ▲Lientox Injection 100 units, Lientox Injection 200 units (Pharmaresearch).

Hugel's botulinum preparation 'Botulex Injection' (Photo by Hugel)

Currently, for biological products requiring special attention for health and hygiene, safety and efficacy must be ensured by obtaining batch release approval for each manufacturing unit after the MFDS director reviews manufacturing and quality control data and conducts testing before domestic sales. Additionally, export-only drugs, which are approved under conditions that the manufacturer produces them solely for export without domestic sales based on the importer's specifications, are prohibited from being sold domestically.

The MFDS has ordered both companies to recall and dispose of the distributed drugs to prevent their use.

However, Hugel is strongly opposing these measures. The company claims that the products are 'export-only products' that are exported overseas immediately through domestic trading companies and are therefore not subject to national batch release approval. Hugel has filed an administrative lawsuit to cancel the product approval cancellation and requested a suspension of execution. Hugel argues that the MFDS suddenly raised issues with distribution practices that had not been problematic until now.

Nevertheless, the MFDS maintains a firm stance. On the 17th of last month, Kim Gang-rip, head of the MFDS, explained at a press briefing held at the MFDS in Osong, Chungbuk, that the measures are "appropriate and necessary" and "in accordance with current laws and regulations."

Kim further emphasized, "Although multiple companies claim that their actions were based on customary practices and a lack of understanding of the reality, if necessary, the court will make a judgment on this matter," reiterating that the measures are "understood as actions in accordance with current laws and regulations."