A human skin-based model to test skin irritation by medical devices developed by the National Institute of Food and Drug Safety Evaluation under the Ministry of Food and Drug Safety on May 14 was designated a global standard of the International Organization for Standardization. (Yonhap News)

By Lee Dasom

The National Institute of Food and Drug Safety Evaluation, an affiliate of the Ministry of Food and Drug Safety, on May 22 said an alternative method of animal testing that the institute developed was made a global standard on May 14 by the International Organization for Standardization (ISO).

This is the country's first method of its kind to gain ISO designation.

Developed since 2019 by the Korean Center for the Validation of Alternative Methods under the institute, the method gauges skin irritation by medical devices using a domestically developed model using human skin.

The 3-D model is made of human epidermal tissue skin keratinocytes that were developed to be biochemically and morphologically similar to human skin.

The ministry said, "The testing method's designation as an ISO global standard is expected to help stimulate the domestic biohealth sector, as well as save time and money when industry players like nonclinical testing institutes study skin irritation by medical devices."

"We will keep working with the Organisation for Economic Co-operation and Development and ISO to globally coordinate homegrown alternative methods of animal testing, boost regulatory consistency and actively support the invigoration of such methods."

dlektha0319@korea.kr