Advanced Therapy medicinal products for autologous chondrocytes and comparison of regulatory systems in target countries.
Regen Ther
; 20: 126-137, 2022 Jun.
Article
en En
| MEDLINE
| ID: mdl-35582708
AC, Autologous chondrocyte; ACB, Advisory Committee on Biologicals; ACI, Autologous chondrocyte implantation; ATMPs; ATMPs, Advanced therapy medicinal products; Advanced therapy medicinal products; Autologous chondrocytes; CAT, Committee for Advanced Therapies; CBER, Cellular, Tissue, and Gene Therapies Advisory Committee; CFR, Code of Federal Regulation; CHMP, Committee for Medicinal Products for Human Use; CPRC, Central Pharmaceutical Affairs Council; EC, European Commission; EMA, European Medicine Agency; EU, European Union; FDA, Food and Drug Administration; HCT/Ps; HCT/Ps, Human cells, tissues, and cellular and tissue-based products; ICRS, International Cartilage Regeneration & Joint Preservation Society; ISCT, International Society for Cell & Gene therapy; KOOS, Knee injury and Osteoarthritis Outcome; MF, Microfracture; MFDS, Ministry of Food and Drug Safety; MHLW, Ministry of Health, Labor, and Welfare; MOCART, Magnetic resonance Observation of Cartilage Repair Tissue; PAFSC, Pharmaceutical Affairs and Food Sanitation Council; PHS, Public Health Service; PMD, Pharmaceutical and Medical Device; PMDA, Pharmaceuticals and Medical Devices Agency; TEPs, Tissue Engineered Products; TGA, Therapeutic Goods Administration; US, United States; VAS, Visual Analogue Scale
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1
Colección:
01-internacional
Base de datos:
MEDLINE
Tipo de estudio:
Observational_studies
Idioma:
En
Revista:
Regen Ther
Año:
2022
Tipo del documento:
Article
Pais de publicación:
Países Bajos