Journal of Veterinary Science

  • 제22권1호
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  • Pages.6.1-6.6
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  • 2021
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  • 1229-845X(pISSN)
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  • 1976-555X(eISSN)
대한수의학회 (The Korean Society of Veterinary Science)
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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)
  • 투고 : 2020.05.04
  • 심사 : 2020.10.12
  • 발행 : 2021.01.31
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초록

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.

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과제정보

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

참고문헌

  1. Ding S, Schultz PG. A role for chemistry in stem cell biology. Nat Biotechnol. 2004;22(7):833-840. https://doi.org/10.1038/nbt987
  2. Xing F, Li L, Zhou C, Long C, Wu L, Lei H, et al. Regulation and directing stem cell fate by tissue engineering functional microenvironments: scaffold physical and chemical cues. Stem Cells Int. 2019;2019:2180925.
  3. Petricciani J, Hayakawa T, Stacey G, Trouvin JH, scientific considerations for the regulatory evaluation of cell therapy products. Biologicals. 2017;50:20-26. https://doi.org/10.1016/j.biologicals.2017.08.011
  4. Ku HO, Yi H, Park YI, Jeon BS, Kang HG, Kim YS, et al. Guideline on safety evaluation of cell-based medicinal products for animal use. J Vet Sci. 2019;20(2):e14. https://doi.org/10.4142/jvs.2019.20.e14
  5. Food and Drug Administration. Cell-Based Products for Animal Use. Report N˚: FDA-2014-D-0634, June, 2015 [Internet]. Silver Spring: The Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM); https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-218-cell-based-products-animal-use. Updated 2018. Accessed 2020 Apr 20.
  6. European Medicines Agency. Questions and Answers on Allogeneic stem cell-based products for veterinary use: specific questions on sterility-Revision 1. Report N˚: EMA/CVMP/ADVENT/751229/2016-Rev.1, June 20, 2019 [Internet]. Amsterdam: European Medicines Agency's (EMA) Committee for Medicinal Products for Veterinary Use (CVMP); https://www.ema.europa.eu/en/documents/scientific-guideline/questions-answers-allogeneic-stem-cell-based-products-veterinary-use-specific-questions-sterility_en.pdf. Updated 2019. Accessed 2020 Apr 20.
  7. Vestergaard HT, D'Apote L, Schneider CK, Herberts C. The evolution of nonclinical regulatory science: advanced therapy medicinal products as a paradigm. Mol Ther. 2013;21(9):1644-1648. https://doi.org/10.1038/mt.2013.175