Regulation of Generic Drugs in Japan: the Current Situation and Future Prospects
Journal Title: The AAPS Journal - Year 2015, Vol 17, Issue 5
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.
Authors and Affiliations
Ryosuke Kuribayashi, Maki Matsuhama, Kenichi Mikami
Keywords
Related Articles
- EP ID EP681012
- DOI 10.1208/s12248-015-9777-x
- Views 59
- Downloads 0
Reliability and Extension of Quantitative Prediction of CYP3A4-Mediated Drug Interactions Based on Clinical Data
The online version of this article (doi:10.1208/s12248-014-9663-y) contains supplementary material, which is available to authorized users.
Morphology and buoyancy of oil-entrapped calcium pectinate gel beads
A new emulsion-gelation method to prepare oil-entrapped calcium pectinate gel (CaPG) beads capable of floating in the gastric condition was designed and tested. The gel beads containing edible oil were prepared by either...
AIDS Treatment with Novel Anti-HIV Compounds Improved by Nanotechnology
The first International Symposium of Nanomedicine on AIDS “AIDS Treatment with Novel Anti-HIV compounds Improved by Nanotechnology” was held November 19–20, 2009 in Beijing, China. This symposium...
Drug Delivery Approaches in Addressing Clinical Pharmacology-Related Issues: Opportunities and Challenges
Various drug delivery approaches can be used to maximize therapeutic efficacy and minimize side effects, by impacting absorption, distribution, metabolism, and elimination (ADME) of a drug compound. For those drugs with...
A Neutralizing Antibody Assay Based on a Reporter of Antibody-Dependent Cell-Mediated Cytotoxicity
Benralizumab is a humanized anti-IL5 receptor α (IL5Rα) monoclonal antibody (mAb) with enhanced (afucosylation) antibody-dependent cell-mediated cytotoxicity (ADCC) function. An ADCC reporter cell-based n...