The Ministry of Food and Drug Safety (MFDS) has issued Guide-0298-02, establishing a comprehensive framework for evaluating dendritic cell therapies for cancer treatment. Developed under the Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals, the guideline details quality, nonclinical, and clinical requirements. It includes criteria for cytokine-stimulated monocyte manufacturing (CD14+, CD34), confirmatory surface antigen testing, purity and viability assessments, and potency evaluation through antigen presentation and T-cell activation. Nonclinical expectations address efficacy, biodistribution, and toxicity, while clinical evaluation focuses on safety indicators such as immunogenicity, infusion reactions, and tumor response efficacy. The guidance also emphasizes reassessment when changing therapeutic indications or administration routes, ensuring regulatory consistency, patient safety, and scientific rigor in advancing regenerative cancer therapies in South Korea.
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