Programs such as the “Expanded Access Program” and the “compassionate use” system, have been established in the United States and Europe on ethical grounds to provide unapproved drugs for the treatment of fatal diseases with no alternative therapeutic agents. From the perspective of ensuring quality, efficacy and safety, drugs used in clinical practice are, in principle, those that have obtained marketing approval on the basis of the “The Act on Securing the Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical devices” (Act No. 145 of 1960; hereinafter, the “PMD Act”)