Reinforced Approval System for Natural Medicines

Abstract

The pharmaceutical approval system in Japan is basically designed to deal with chemically synthesized drugs. Since natural medicines such as Kampo medicines are multi-component complexes with diversity, it is not easy to develop new natural medicines under a unified pharmaceutical approval system that does not distinguish between chemical drugs and natural medicines. In this review, I will discuss the approval standards for the OTC natural medicines and the application guidelines for approval of the prescription natural medicines, which were established to overcome this hurdle in the pharmaceutical approval system.