Journal List > J Vet Sci > v.20(2) > 1148331

TOOLS
Ku, Yi, Park, Jeon, Kang, Kim, and Park: Guideline on safety evaluation of cell-based medicinal products for animal use
Guideline

J Vet Sci 2019;20(2):e14.

Published online: 4 March 2019

DOI: https://doi.org/10.4142/jvs.2019.20.e14

Guideline on safety evaluation of cell-based medicinal products for animal use

Hyun-Ok Ku*, Hee Yi, Young-Il Park, Byung-suk Jeon, Hwan-Goo Kang, Yong-Sang Kim, Bong-Kyun Park

Veterinary Drugs & Biologics Division, Animal and Plant Quarantine Agency, Gimcheon 39660, Korea

*Corresponding author: Hyun-Ok Ku Veterinary Drugs & Biologics Division, Animal and Plant Quarantine Agency, 177 Hyeokshin 8-ro, Gimcheon 39660, Korea. E-mail: kuho@korea.kr

Received 6 November 2018       Revised 24 February 2019       Accepted 24 February 2019

Copyright © 2019 The Korean Society of Veterinary Science

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

With the increased use of cell therapy in the veterinary sector, there is a growing demand for the development of cell-based medicinal products and the determination of their safety. Currently, the Korean Animal and Plant Quarantine Agency has established a guideline for evaluating the safety of cell-based medicinal products for animal use. The guideline includes items related to definition, classification, management, manufacturing procedure and quality control (standard and test method), stability testing, toxicity testing, pharmacological testing, and performance of clinical trials. In addition, testing protocols related to safety assessment of animal cell-based products such as chromosome karyotyping, tumorigenicity testing, confirmatory testing of biodistribution and kinetics, and target animal safety testing are described in detail. Moreover, because cell-based medicinal products are novel therapies, deviations from traditional designs may be justified in order to obtain relevant safety information on the treatment. Additionally, this guideline can be amended on the basis of new scientific findings.

Keywords: Cell-based medicinal product, cell therapy, safety evaluation, animal use

References

1. Animal and Plant Quarantine Agency. APQA Notice No. 2018-5: Regulations on Safety and Efficacy Evaluation for Veterinary Medicinal Products [Internet]. Animal and Plant Quarantine Agency;2018. [updated 2018 February 22; cited 2019 March 15]. Available from:. http://www.qia.go.kr/bbs/lawAnn/viewLawWebAction.do?id=152876&type=0.
2. Food and Drug Administration. Guidance for Industry No. 218: Cell-Based Products for Animal Use [Internet]. Center for Veterinary Medicine;2015. [updated 2015 June; cited 2019 March 15]. Available from:. https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM405679.pdf.
3. The Japanese Society for Animal Vaccine and Biomedical Research. 2014 Project Report for Development of Safety Testing of Regenerative Medicinal products for Animal Use: Draft Guideline on the Ensurement of Quality and Safety for Regenerative Medicinal Products (Allogeneic-derived) for Animal Use [Internet]. The Japanese Society for Animal Vaccine and Biomedical Research;2015. [updated 2015 March; cited 2019 March 15]. Available from:. http://www.jsavbr.jp/data/1432867667.pdf.
4. Animal and Plant Quarantine Agency. APQA Notice No. 2016-22: Guideline on Toxicity Testing for Veterinary Medicinal Products [Internet]. Animal and Plant Quarantine Agency;2016. [updated 2016 March 9; cited 2019 March 15]. Available from:. http://www.law.go.kr/LSW/admRulLsInfoP.do?admRulSeq=2100000042143.
5. Ministry of Food and Drug Safety. MFDS Guideline No. B1-2014-3-020. Guideline in Quality, Non-clinical and Clinical Assessment of Stem Cell Therapy Product [Internet]. Ministry of Food and Drug Safety;2014. [updated 2014 December; cited 2019 March 15]. Available from:. http%3A%2F%2Fwww.nifds.go.kr%2Fbrd%2Fm_158%2Fdown.do%3Fbrd_id%3D235%26seq%3D11723%26data_tp%3DA%26file_seq%3D1&usg=AOvVaw0L2fDSu9vg2J6ZnoOtfByd.
6. Animal and Plant Quarantine Agency. APQA Notice No. 2015-29: Guideline on Clinical Trial Management of Veterinary Medicinal Products [Internet]. Animal and Plant Quarantine Agency;2015. [updated 2015 October 20; cited 2019 March 15]. Available from:. https://www.qia.go.kr/guide/sitemap/bbs/lawAnn/viewLawWebAction.do?id=132510&type=0.
7. European Medicines Agency. EMA/CVMP/ADVENT/193811/2016: Stem Cell-Based Products for Veterinary Use: Specific Questions on Target Animal Safety to Be Addressed by ADVENT [Internet]. Committee for Medicinal Products for Veterinary Use;2016. [updated 2016 July 14; cited 2019 March 15]. Available from:. https://www.ema.europa.eu/en/stem-cell-based-products-veterinary-use-specific-questions-sterility-be-addressed-ad-hoc-expert.
8. The Veterinary International Cooperation on Harmonization. VICH GL43: Target Animal Safety for Veterinary Pharmaceutical Products [Internet]. The Veterinary International Cooperation on Harmonization Steering Committee;2008. [updated 2008 July; cited 2019 March 15]. Available from:. https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm052464.pdf.
TOOLS
Similar articles