The Ministry of Food and Drug Safety (MFDS) said on Friday that it initiated administrative penalties and recall and destruction procedures against Huons BioPharma for the unauthorized sale of its botulinum toxin (BTX) Liztox Inj. 100 units without obtaining domestic export approval.
The penalty includes the revocation of the item's license. Additionally, the investigation found that Huons sold products in Korea that fall under the category of export-only drugs. The company will also be subject to a six-month suspension of all manufacturing operations.
Domestic export approval aims to ensure the safety and effectiveness of biological products that require special attention for health and hygiene reasons, before being sold in Korea.
Accordingly, data on manufacturing and quality control must be reviewed by the MFDS, and shipment approval must also be obtained for each manufacturing unit through testing and inspection by the regulatory agency.
On the other hand, export-only drugs refer to drugs licensed on the condition that the manufacturer procedures only for export and not for sale in Korea based on the specification requested by the importer to which the product is exported.
In violation of these two counts, the MFDS issued a recall and destruction order to prevent the items from being distributed in Korea and suspended their use as a measure to protect consumers during administrative filings.
Together with the Ministry of Health and Welfare (MOHW) and the Health Insurance Review and Assessment Service (HIRA), safety bulletins were also issued to doctors, pharmacists, and other professionals requesting their cooperation in replacing the items subject to license revocation with other products.
“We will continue to take strict measures in accordance with the law against drugs whose quality, safety, and effectiveness have not been confirmed so that the public can use safe and quality drugs,” said an official from the MFDS. “We will continue to guide the industry to comply with laws and regulations to enhance public confidence in the domestic biopharmaceutical industry.”