Hanyang Med Rev.  2012 Aug;32(3):163-169. 10.7599/hmr.2012.32.3.163.

Developmental Strategy for Stem Cell Therapy Products in Regulatory Considerations

  • 1Bioengineering Institute, Corestem Inc., Seoul, Korea. kskim@corestem.com


Expectation that stem cell therapy products will prove better and more effective in treating a variety of medical conditions continues to drive expanding research efforts. Stem cell therapy products consist of, or are derived from, populations of stem cell progenitors. They are complex and dynamic biological therapies which are highly regulated for safety and efficacy as biological products. The Korea Food Drug Administration (KFDA) is the legal authority responsible to regulate stem cell therapy products as stipulated by the Pharmaceutical Affairs Act. In this article, the regulatory review process used by the KFDA to assess the safety and effectiveness of novel stem-cell therapy products is described. The agency regularly updates and re-evaluates recommendations applicable to production and testing of stem cell therapy products based on the accumulation of scientific and clinical experiences.


Stem Cells; Biological Agents; Informed Consent By Minors; Safety; Treatment Outcome

MeSH Terms

Biological Agents
Biological Therapy
Informed Consent By Minors
Stem Cells
Treatment Outcome
Biological Agents
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