Journal of Veterinary Science

The Korean Society of Veterinary Science (대한수의학회)
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International regulatory considerations pertaining to the development of stem cell-based veterinary medicinal products

  • Jeon, Byung-Suk (Toxicological Evaluation Laboratory, Animal and Plant Quarantine Agency) ;
  • Yi, Hee (Toxicological Evaluation Laboratory, Animal and Plant Quarantine Agency) ;
  • Ku, Hyun-Ok (Toxicological Evaluation Laboratory, Animal and Plant Quarantine Agency)
  • Received : 2020.05.04
  • Accepted : 2020.10.12
  • Published : 2021.01.31
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Abstract

Stem cell-based products (SCPs) are an emerging field of veterinary medicine that focuses on the regeneration, repair, or replacement of damaged tissues or organs. However, there are some issues in applying the traditional regulatory guideline for the approval of SCPs as veterinary medicinal products. This article describes the positions of Korea, US, and EU regarding SCPs, and compares the regulatory guidelines of each country for their safety evaluation. Although there are some differences in the regulatory guidelines, similar considerations in identifying the quality of SCPs and their safety has adopted. Overall, these guidelines need to be harmonized among countries.

Keywords

Acknowledgement

This project was supported by research funds from Animal and Plant Quarantine Agency, Republic of Korea.

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