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Cellular Therapy

Manufacturing process of R-SUDs (1) Receipt of recyclable components from medical institutions [1] Recyclable components must be those currently used in Japan. (Section 4-1 (1) of the Remanufacturing Standards) [2] Recyclable components must meet the following conditions. Appropriate selection shall be conducted at medical institutions to ensure that used SUDs not meeting these conditions are not included in recyclable components. (Section 4-1 (2) (3) (4) (6) of the Reprocessing Standards) a Because it is difficult to neutralize or remove prions, components to be recycled must be ones that have not come in contact with the brain, spinal cord, dura mater, cerebral ganglion, spinal ganglion, retina or optic nerve. b. Components to be recycled must not have been previously implanted in a human body. c Components to be recycled must have not been previously used to treat or examine patients presenting with any Class I Infectious Disease, Class II Infectious Disease, Class III Infectious Disease, Class IV Infectious Disease, novel influenza infection, Designated Infectious Disease, or Novel Infectious Disease as specified in Article 6 of the “Act on the Prevention of Infectious Diseases and Medical Care for Patients with Infectious Diseases” (Act No. 114 of 1998), or those specified in Article 8, Paragraphs 1 through 3 of the aforementioned law. d Recyclable components must be ones that have been separately stored to avoid damage, deterioration, or contamination with microbial pathogen and other pathogenic agents that cannot be inactivated or removed in the manufacturing process. [3] MAHs of R-SUDs must specify procedures for receiving used SUDs from medical institutions to ensure that the above conditions are appropriately observed. The concerned procedures shall specify shape of transportation containers, frequency of receipt of recyclable components from medical institutions, and agreement with medical institutions in terms of responsibilities related to their receipt. The relevant procedures must each be reviewed individually and specifically during the review process and then specified in the approval certificate (Section 4-1 (5) of the Reprocessing Standards).