[KSCI] Korea Science Citation Index Service

http://dx.doi.org/10.4142/jvs.2021.22.e6

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)

Publication Information

Journal of Veterinary Science / v.22, no.1, 2021 , pp. 6.1-6.6 More about this Journal

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

Stem cell-based products; veterinary medicinal products; regulatory guidelines; quality; safety;

Citations & Related Records

Reference

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