Government regulations on cellular therapy and proposed approach related with these products by KFDA.
Advances in biomedical technology has enabled the research and use of novel therapies in cellular transplantation. A number of trials using chondrocyte and autologous skin products are underway and will soon become commercially available for clinical utilization. However, the Korea Food and Drug Administration currently lack systematic regulations for efficacy and safety evaluation of the emerging therapies. Specifically, dose related studies are uncontrolled and availability of clinical research centers is inadequate. Thus, patients are receiving therapy without guidelines for indication, dose, and adequate safety profiles. We propose criteria for cases in which these therapies can be used and advocate IRB determined quality assurance for future research.
Yoo
Moo Young
MY
Division of Biologics Pharmaceutical Safety Bureau, Korea Food and Drug Administration, Seoul, Korea. yoomy7020@kfda.go.kr
D035843:Biomedical Research / Q000592:standards; D017690:Cell Transplantation / Q000331:legislation & jurisprudence*; D017408:Guidelines as Topic; D006801:Humans; D007723:Korea; D011786:Quality Control