Developmental Strategy for Stem Cell Therapy Products in Regulatory Considerations

In Young Chang; Kyung Suk Kim

doi:10.7599/hmr.2012.32.3.163

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Chang and Kim: Developmental Strategy for Stem Cell Therapy Products in Regulatory Considerations

Review Article

Hanyang Medical Reviews

Hanyang Medical Reviews 2012; 32(3): 163-169.

Published online: 24 August 2012

DOI: https://doi.org/10.7599/hmr.2012.32.3.163

Developmental Strategy for Stem Cell Therapy Products in Regulatory Considerations

In Young Chang, Kyung Suk Kim

Bioengineering Institute, Corestem Inc., Seoul, Korea.

Corresponding author (kskim@corestem.com)

Received 28 June 2012 Accepted 20 July 2012

Abstract

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.

Keywords: Stem Cells, Biological Agents, Informed Consent By Minors, Safety, Treatment Outcome

Appendices

Appendix 1

Documents for Investigational New Drug (IND) Submission

Appendix 2

Critical Issues to Establish QC Item of Stem Cell Therapy Products

Appendix 3

Criteria and Issues of Quality Contol (QC) Test for Cell Therapy Products

Appendix 4

Summary of GMP Guideline for Cell Therapy Products

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