Developmental Strategy for Stem Cell Therapy Products in Regulatory Considerations / 한양의대학술지
Hanyang Medical Reviews
;
: 163-169, 2012.
Artículo
en Coreano
| WPRIM
| ID: wpr-192557
ABSTRACT
Expectation that stem cell therapy products will prove better and more effective in treating a variety of medical conditions continues to drive expanding research efforts. Stem cell therapy products consist of, or are derived from, populations of stem cell progenitors. They are complex and dynamic biological therapies which are highly regulated for safety and efficacy as biological products. The Korea Food Drug Administration (KFDA) is the legal authority responsible to regulate stem cell therapy products as stipulated by the Pharmaceutical Affairs Act. In this article, the regulatory review process used by the KFDA to assess the safety and effectiveness of novel stem-cell therapy products is described. The agency regularly updates and re-evaluates recommendations applicable to production and testing of stem cell therapy products based on the accumulation of scientific and clinical experiences.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Asunto principal:
Células Madre
/
Terapia Biológica
/
Resultado del Tratamiento
/
Consentimiento Informado de Menores
/
Corea (Geográfico)
Tipo de estudio:
Guía de Práctica Clínica
País/Región como asunto:
Asia
Idioma:
Coreano
Revista:
Hanyang Medical Reviews
Año:
2012
Tipo del documento:
Artículo
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