International regulatory considerations pertaining to the development of stem cell-based veterinary medicinal products
| Autor: | Hee Yi, Hyun Ok Ku, Byung Suk Jeon |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
safety
Veterinary Medicine Veterinary medicine General Veterinary Legislation Veterinary Stem Cells media_common.quotation_subject Guideline United States Veterinary Policy quality Perspective veterinary medicinal products Republic of Korea Animals Quality (business) European Union Business Stem cell-based products regulatory guidelines Stem Cell Transplantation media_common |
| Zdroj: | Journal of Veterinary Science |
| ISSN: | 1976-555X 1229-845X |
| DOI: | 10.4142/jvs.2021.22.e6 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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