Abstract
Regarding viral vector products as gene therapy products, several points to consider were summarized from the perspectives of quality, non-clinical efficacy, non-clinical safety, non-clinical biodistribution, clinical evaluation, and Cartagena Act compliance. In addition, the timing and reliability of the nonclinical studies and the consistency of the quality of the test article used were summarized as points to be noted in the evaluation. When developing viral vector products, it is necessary to consider quality, non-clinical, and clinical evaluation methods depending on the product and disease characteristics. Utilizing PMDA consultation services is encouraged in order to develop products efficiently.
