Regulatory Requirement and Registration Process of Generic Drugs in Japan

Generic product is established by Pharmaceuticals and Medical Devices Agency to be approved for marketing in Japan respectively. Japan market is important to pharmaceutical industry. Japan is under one of the Regulated markets and owning the world's second largest pharmaceutical market. Generic drugs are replaceable with original proprietary drugs, as they have the same active pharmaceutical ingredients, strength, quality, effects, dosage forms, indications, directions and dosage. The cost of generic product is lower than innovator product, because the developmental cost is low. The expansion of medical expenses is an important issue in many countries, including Japan, Europe and the USA and promotion of generic drugs has been demanded to solve this issue in Japan. An overview of checklist for requirements and registration process of generic product in Japan is provided.