Lower Proportion of Spontaneous Adverse Event Reports for Generic Drugs by Comparison With Original Branded Drugs at the Postmarket Stage in Japan

Author:

Takami Akina12,Hirata Kaori3,Ishiguro Chieko3,Hanaoka Hideki24,Uyama Yoshiaki235

Affiliation:

1. Office of New Drug IPharmaceuticals and Medical Devices Agency Tokyo Japan

2. Department of Regulatory Science of MedicineGraduate School of MedicineChiba University Chiba Japan

3. Office of Medical Informatics and EpidemiologyPharmaceuticals and Medical Devices Agency Tokyo Japan

4. Division of Clinical Research CenterChiba University Hospital Chiba Japan

5. Graduate School of MedicineNagoya University Nagoya Japan

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference29 articles.

1. Ministry of Health Labour and Welfare.Medical care cost of fiscal year 2016 (in Japanese). . Accessed October 26 2018.

2. Major Trends in the U.S. Health Economy since 1950

3. Ministry of Health Labour and Welfare.Roadmap to further promotion of generic drug utilization (in Japanese). (2013). Accessed October 26 2018.

4. Ministry of Health Labour and Welfare.Japanese market share of generic drugs (in Japanese). . Accessed October 26 2018.

5. Post-market drug safety evidence sources: an analysis of FDA drug safety communications

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