Regenerative Medicinal Products Act｜第 4 條｜Food and Drug Administration｜Act｜In Force
衛生福利部｜v1.0
Effective Date: 2026-01-01｜Last Amended: 2024-06-19
Regenerative medicinal products are divided into the following categories: 1. Gene therapy medicinal products: medicinal products that insert or administer recombined genes to humans to treat, prevent, or diagnose disease. 2. Cell therapy medicinal products: medicinal products that contain processed/manipulated cells or their derivatives to treat, prevent, or diagnose disease. 3. Tissue-engineered medicinal products: medicinal products that contain engineered/altered tissues or cells to repair, regenerate, or replace human tissues/organs. 4. Combinational medicinal products: medicinal products that contain one or more medical devices as an integral part of medicinal products mentioned in the preceding three subparagraphs.