Regulation of Generic Drugs in Japan: the Current Situation and Future Prospects.

Generic drugs are interchangeable with original proprietary drugs, as they have the same active pharmaceutical ingredients, dosage forms, strength, quality, indications, effects, directions, and dosage. The cost of generic drugs is lower than original drugs, because the developmental cost is lower. The expansion of medical expenses is an important issue in many countries, including Japan, the USA, and Europe, and promotion of generic drugs has been demanded to solve this issue in Japan. Generic drug approval review in Japan is conducted by the Pharmaceuticals and Medical Devices Agency (PMDA), which reviews the equivalence of the original drugs from the viewpoint of quality, efficacy, and safety, based on documentation submitted by the generic drug applicants. However, the details of the generic drug review in Japan have not been reported. In this report, we introduce the application types, the number of applications and approvals, and the review timeline of generic drugs in Japan. In addition, we discuss recent consultations and future prospects.