Regarding the Implementation of Xenotransplantation under the Act on the Safety of Regenerative Medicine, etc.
Regarding the "Evaluation Items for Quality and Safety" described in the notification – 8th Expert Committee on the Revision of the Gene Therapy Clinical Research Guidelines
Technical Guidance on Quality, Nonclinical, and Clinical Studies for Regenerative Medical Products (Human Cell-Based Products)
Mycoplasma Test Methods (Unofficial English Translation)
1223 VALIDATION OF ALTERNATIVE MICROBIOLOGICAL METHODS
1180 HUMAN PLASMA
1050.1 DESIGN, EVALUATION, AND CHARACTERIZATION OF VIRAL CLEARANCE PROCEDURES
1047 GENE THERAPY PRODUCTS
1046 CELL-BASED ADVANCED THERAPIES AND TISSUE-BASED PRODUCTS
1044 CRYOPRESERVATION OF CELLS
1024 BOVINE SERUM
FETAL BOVINE SERUM—QUALITY ATTRIBUTES AND FUNCTIONALITY TESTS
1229.17 MYCOPLASMA STERILIZATION
63 MYCOPLASMA TESTS
WATER FOR PHARMACEUTICAL PURPOSES
1237 VIROLOGY TEST METHODS
1239 VACCINES FOR HUMAN USE—VIRAL VACCINES
VACCINES FOR HUMAN USE—GENERAL CONSIDERATIONS——USP
PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS