MFDS cancels product approval for Huons Biopharma's 'Liztox Injection'

Violation of National Shipment Approval... 6-Month Manufacturing Suspension
Huons "Plans for Legal Actions Including Objection"

The Ministry of Food and Drug Safety (MFDS) announced on the 4th that it has canceled the product approval for Huons Biopharma's botulinum toxin (BTX) preparation 'Liztox Injection 100 Units,' which was sold domestically without obtaining national batch release approval, and has suspended all manufacturing operations for six months.

Huons Biopharma Riztox Injection 100 Units.
[Image provided by Huons Biopharma]

Earlier, on the 2nd of last month, the MFDS detected that Huons Biopharma's Liztox Injection 100 Units was sold domestically without national batch release approval, prompting administrative actions including product approval cancellation and procedures for recall and disposal.

Huons Biopharma was also ordered to suspend manufacturing operations for six months. This was due to confirmation that the product, which is designated for export only, was sold domestically without approval. According to the MFDS, biological products requiring special sanitary precautions must undergo review of manufacturing and quality control data by the MFDS and obtain batch release approval for each manufacturing unit before domestic sales.

The MFDS ordered Huons Biopharma to recall and dispose of the products in circulation to prevent the use of the canceled drug. Additionally, medical institutions and others storing the product were urged to actively cooperate with the recall.

An MFDS official stated, "We will continue to strictly enforce laws against acts threatening public health, such as illegal distribution of pharmaceuticals, and will guide and inspect the industry to ensure the supply of safe medicines."

Previously, in addition to Huons Biopharma, companies such as Medytox, Hugel, PharmaResearch, Jetema, Korea BMI, and Korea BNC also received product approval cancellations for BTX preparations from the MFDS for the same reason. These companies filed injunctions to suspend enforcement and administrative lawsuits with the administrative court. As the court accepted the injunctions, these products are currently being shipped normally.

The ongoing conflict between regulatory authorities and the industry over national batch release approval stems from differing interpretations of the export process for botulinum toxin preparations. Biopharmaceuticals distributed domestically must obtain national batch release approval from the MFDS to check for deterioration or foreign substance contamination. This approval involves review of manufacturing and quality control data and testing for each manufacturing batch. In contrast, export-only pharmaceuticals do not require national batch release approval but cannot be distributed domestically.

The companies subject to MFDS sanctions have been exporting BTX preparations through indirect export methods. First, they supply BTX preparations to domestic trading companies or wholesalers, who then export the products. During this process, BTX preparations were transferred to trading companies without national batch release approval, but the MFDS judged this as domestic sales. Since export-only pharmaceuticals were sold domestically, it was considered a violation of the Pharmaceutical Affairs Act.

On the other hand, the companies argue that indirect export through supplying intermediaries for export purposes has been a long-standing practice, and they claim the MFDS is suddenly raising issues. The industry also asserts that the MFDS has maintained the position that national batch release approval is not required for export-only pharmaceuticals.

Huons Biopharma is expected to file an injunction to suspend enforcement against the MFDS, similar to other companies that received similar sanctions. A Huons Biopharma representative stated, "We plan to actively take all necessary legal measures, including filing objections."

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