Comparison of Regulations for the Development of Oncolytic Virus Therapy in the United States, the European Union, and Japan.

Oncolytic Viral Therapy (OVT) is one of the novel approaches for treating cancer and has a preferable safety profile. If a response to the therapy can been demonstrated, it can become one of the main therapies for cancer. We conducted a comprehensive comparative analysis of regulations for OVT development in the United States (US), the Europe Union (EU) and Japan to confirm a perceived lag in OVT development activities in Japan and explore its regulatory basis. Clinical development of OVT has begun all over the world. However, most of the development has been conducted outside of Japan. The lack of OVT development was not caused by scientific reasons but rather regulatory reasons. In this context, this article focuses on the regulatory dierences surrounding OVT throughout the developed world. In Japan, unlike the US, data from clinical development are required to obtain regulatory approval from Pharmaceuticals and Medical Devices Agency (PMDA); in other words, data from clinical research are not enough. However, in the US, data from either clinical development or clinical research can be utilized for new drug applications. In addition, Japan ratified the Cartagena Protocol, which demands special procedures for the use of viruses, which are key to OVT; the US need not follow these procedures as it did not ratify the Protocol. In short, in order to stimulate the development of OVT in Japan, we should harmonize our regulations on OVT with those of the US and EU.