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Organoid Treatment Guidelines
First Established Globally by MFDS

Photo: 메디컬투데이

In short

The Ministry of Food and Drug Safety (MFDS) has created the world's first evaluation guidelines for organoid cell therapies.

A domestic company, Organoid Science, solely conducted the foundational research for these guidelines.

The guidelines were explained at an educational session held on the 6th in Gangnam-gu, Seoul.

Key facts

WhenThe guidelines were established and published on October 29th, and an implementation workshop was held on the 6th.
WhoOrganoid Science independently carried out commissioned research for the MFDS.
WhatQuality and non-clinical evaluation guidelines for organoid-based cell therapies were created.
HowEvaluation considerations were provided, including 3D structure, cellular composition, in-vivo distribution, and tumorigenicity.

What it means for me

There will be no direct change to daily life, but this news could influence the speed of domestic biopharmaceutical new drug development.