July 8, 2025

Figure 1: 60% of globally approved new drugs cannot be used in Japan.
(Reference: Daisk Tanaka、Regulatory updates in Japan, 12th Joint Conference of Taiwan and Japan on Medical Products Regulation, 7 October 2024)

Figure 2: Technology-enabled Model-informed Drug Development Ecosystem
(Reference: Rajesh Krishna, The Utility of Model-Informed Drug Development for Rare Diseases, May 20, 2022 Blog, Certara | Model-Informed Drug Development for Rare Diseases)
Learn more about MIDD and regulatory services for Pediatrics and Rare Diseases for PMDA submissions
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References
厚生労働省Press Release 令和6年度厚生労働科学特別研究事業「ドラッグ・ロスの実態調査と解決手段の構築」研究班の整理結果に関する公表、2025/3/31.
医薬品医療機器総合機構(PMDA)理事長 藤原康弘、ドラッグ・ロスに対するPMDAの取り組み、第35回抗悪性腫瘍薬開発フォーラム, 2024/02/17
Rajesh Krishna, The Utility of Model-Informed Drug Development for Rare Diseases, May 20, 2022 Blog, Certara | Model-Informed Drug Development for Rare Diseases
Certara. 4 Ways That Mechanistic Modeling Accelerates Bispecific (and Multispecific) Antibody Drug Development. Blog, Sep 12, 2024.
Certara. Quantitative Systems Pharmacology (QSP) Modeling for Immunotherapy-induced Cytokine Release Syndrome. Blog August 20, 2024 .
Fediuk et al. End‑to‑end application of model‑informed drug development for ertugliflozin… CPT: Pharmacometrics & Systems Pharmacology, 2021.
Hasegawa M, Kijima S. MIDD in Japan- Implementations, challenges and opportunities. Adv Drug Deliv Rev. 2025 May;220:115553. doi: 10.1016/j.addr.2025.115553. Epub 2025 Feb 28. PMID: 40024482.

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