MFDS Takes Strong Action to 'Revoke Approval' Against Hugel and PharmaResearch for Selling Botox Without Authorization (Comprehensive)

Cancellation Decision for Approval of 6 Botulinum Toxin Products
Hugel "Proceeding with Cancellation Lawsuit and Suspension of Execution Application"

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).

Currently, for biological products requiring special attention for health and hygiene, safety and efficacy must be ensured by reviewing manufacturing and quality control data and conducting testing and inspection by the MFDS director before domestic sales, and batch release approval must be obtained for each manufacturing batch. Additionally, export-only drugs that manufacturers are permitted to produce solely for export by submitting importers' 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.

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

Hugel strongly opposed the decision. The company claimed that the products were indirectly exported through a trading company established domestically and were not sold to that company for domestic distribution. Therefore, as export-only drugs produced for export, they should not be subject to national batch release approval.

The company emphasized that such indirect exports are recognized as a form of export under the Foreign Trade Management Regulations to encourage exports by small and medium-sized enterprises that cannot directly develop overseas clients, and that this is a common type of export. Furthermore, Hugel stated that the MFDS had previously indicated that export products do not require national batch release approval, and that they simply followed this guidance, with no reason to evade or circumvent the approval if it were required.

Hugel plans to immediately file a cancellation lawsuit (main lawsuit) against the MFDS's action and apply for a suspension of execution.

However, the MFDS maintains a firm stance. At a press conference held on the 17th of last month at the MFDS in Osong, Chungbuk, MFDS Commissioner Kim Kang-lip explained the matter, saying, "I understand this as an appropriate and necessary measure," and added, "It is an action in accordance with current laws."

Commissioner Kim further emphasized, "Although multiple companies claim that their actions were due to customary practice and a lack of understanding of reality, if necessary, the court will make a judgment on this matter," and reiterated that the measure is "understood as an action in accordance with current laws."

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