韓國産 Stem Cell Therapy, Finally Opens Its Way to Japan!
- Biostar Stem Cell Research Institute receives manufacturing approval from Japan’s Ministry of Health and Welfare on Feb. 10th
- Exports to Japan’s medical institution starting in March
Biostar Stem Cell Research Institute, joint operated by R Bio and Nature Cell, announced that it has received approval on manufacture of processed specific cells on Feb. 10th.
Biostar Stem Cell Research Institute applied to Japan’s Ministry of Health and Welfare in August last year for a permission on overseas manufacture of processed specific cells(Catergory 2). A visit from Japan’s PMDA (Parmaceuticals and Medical Devices Agency) took place in December, and Biostar SCRI acquired approval on manufacture of processed specific cells on Feb. 10th.
Japan regulated regenerative medicines as national growth engines industry and established ‘Act on Safety of Regenerative Medicines’ so that manufacture facilities can receive approval of their processed specific cells manufacturing facilities. According to this regulation, when approved, even stem cell manufacture facilities overseas can officially provide Japan with stem cells made in their own countries.
With the manufacture approval, Biostar Stem Cell Research Institute is now able to provide hospitals in Japan with stem cell treatments made in Korea. The export to Japan’s medical institution is planned to start in March.
“I’m happy to open up a way for the stem cell treatments made with our own technology to be exported,” said Dr. Jeong-Chan Ra, the director of Biostar Stem Cell Research Institute. “We will contribute to our country from now on through the exportation of stem cell treatments,” he added.
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