Host: The Japanese Society of Toxicology
Basic requirements of nonclinical safety evaluation for in vivo gene therapy products are shown in “Ensuring the Quality and Safety of Gene Therapy Products” (PSEHB/MDED Notification No.0709-2). It may, however, not always be appropriate to apply this guideline in a uniform way because types, characteristics, and clinical applications of gene therapy products are diverse, and rapid strides are being made in the scientific advancement and accumulation of experience in this area. Therefore, nonclinical safety evaluations of individual products should be done flexibly on a case-by-case basis.
