'Human Tissue Banks' Licensed by Fraud or Misrepresentation Can Be Immediately Expelled

MFDS Announces Amendment to 'Regulations on Human Tissue Safety'

[Asia Economy Reporter Jo In-kyung] The Ministry of Food and Drug Safety announced on the 12th that it has revised, promulgated, and will immediately enforce the partial amendment of the "Regulations on Human Tissue Safety," which includes provisions to immediately expel human tissue banks that obtained approval through false or fraudulent methods.

Human tissue refers to body parts that are not organs, such as bones, cartilage, fascia, skin, amniotic membrane, ligaments, tendons, heart valves, blood vessels, nerves, and pericardium, which can be harvested for medical treatment purposes and transplanted. A tissue bank is an institution that manages human tissues with facilities, equipment, personnel, and quality control systems, and is authorized by the Ministry of Food and Drug Safety.

According to the amendment, if a tissue bank is found to have obtained business licenses, renewal licenses, change licenses, or import/change approvals for human tissues through false or fraudulent methods, its license can be immediately revoked.

Additionally, if a tissue bank repeats the same violation within one year, enhanced penalties will be applied according to the number of repetitions. It is clearly stipulated that for the same violations that occurred before the penalty was imposed, the timing of occurrence will be used as the basis for calculating the degree of enhanced penalties.

An official from the Ministry of Food and Drug Safety stated, "We will continue to prioritize public health and safety by thoroughly managing human tissue safety and operate the system rationally based on regulatory science."

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