Korea Food & Drug Administration's Alternative Animal Testing Method Using Human Skin Models Recognized as International Standard

The Ministry of Food and Drug Safety announced on the 3rd that its self-developed animal alternative test method, the "Medical Device Skin Irritation Test Method Using a Human Skin Model," has been approved as an international standard test method by the International Organization for Standardization (ISO).

According to the Ministry, at the ISO/TC194 technical committee meeting held in the United States from the 23rd to the 27th of last month, the verification results of the test method were reviewed, and ISO unanimously approved the test method as an international standard test method in the field of irritation testing.

The test method approved as an ISO international standard this time is designed to evaluate the biological safety of medical devices and is a type of animal alternative test method. It uses a domestically developed "human skin model," which is biochemically and morphologically similar to human skin, to assess whether substances derived from medical devices cause skin irritation.

This test method's scientific validity was demonstrated through verification led by the Korea Center for the Validation of Alternative Methods (KoCVAM) at three domestic non-clinical testing institutions.

With the approval of the test method using the domestically developed and manufactured human skin model as an ISO international standard test method, the Ministry of Food and Drug Safety expects that the industry, including non-clinical testing institutions, will be able to reduce time and costs when conducting skin irritation tests for medical devices.

The Ministry plans to continue making every effort to develop internationally recognized animal alternative test methods by utilizing the Korea Center for the Validation of Alternative Methods (KoCVAM).

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