Related Experiment Video
Updated: Apr 13, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
Regulation of Generic Drugs in Japan: the Current Situation and Future Prospects
Ryosuke Kuribayashi1, Maki Matsuhama, Kenichi Mikami
1Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan, kuribayashi-ryosuke@pmda.go.jp.
Abstract:
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.
More Related Videos
08:46Regioselective O-Glycosylation of Nucleosides via the Temporary 2',3'-Diol Protection by a Boronic Ester for the Synthesis of Disaccharide Nucleosides
Published on: July 26, 2018
08:31Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
Published on: December 1, 2020
Related Concept Videos
Drug Regulation
Drug Control Governance: Regulatory Bodies and Their Impact
Drug Nomenclature
Drug Classes and Categories
FDA Approved Drugs: Changes to Approved Drugs
Dosage Regimen: Individualization