Amendment of the 'Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products' welcomed by the industry

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On the first day of this month, the Ministry of Food and Drug Safety and the biotech industry welcomed the acceptance of the bill adding 'Regenerative Medical Institutions' as human cell management by the National Assembly, amending the 'Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products'. 

Human Cell Management businesses are operators who collect, import, inspect, process, and supply human cells, which have been mostly in-house product manufacturers or the blood banks. Now that this amendment has been approved, advanced regenerative medical institutions equipped with facilities, equipment, and personnel similar to the standards for human cell management, shall also be recognized as subjects for permits for the management of human cells. This means that advanced regenerative medical institutions can supply raw materials by performing minimal procedures such as simple isolation, washing, freezing, and thawing of cells obtained from patients.

It draws more interest that the patients who have not participated in clinical trials are research subjects, are now able to receive cell therapy according to criteria set by law. Previously, regenerative medicine in South Korea could only be used for research purposes in the field of rare or incurable diseases or conditions lacking other treatments.

Due to the passage of the bill, it is reported from the Ministry of Food and Drug Safety that they expect expanded opportunities for patient treatment using advanced bio-pharmaceuticals such as gene therapy. Korean biotech companies developing cell therapy products including NKMAX, CHA Biotech, and GI Cell welcomed the passage of the amendment to the law by the National Assembly.

It is anticipated through the enactment, that cell and gene therapy will also be accessible to more patients with early-stage diseases, and will boost the development of advanced regenerative medical technologies in South Korea.


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