Expediting Drug Development in Japan: A <scp>PMDA</scp> Perspective
Review time for a new drug in Japan has shortened dramatically since the establishment of the Pharmaceuticals and Medical Devices Agency (PMDA). Nonetheless, Japan faces a new challenge so-called "Drug Loss", which means that new drugs approved overseas have not yet been developed in Japan or that development is delayed. In this manuscript, we describe how PMDA facilitates Japan's drug development to continuously provide innovative drugs to patients.
Authors
- Yasuhiro Araki (ORCID: https://orcid.org/0009-0003-1326-1605)
- Takashi Yasukawa (ORCID: https://orcid.org/0000-0002-1616-067X)
- Yoshiaki Uyama (ORCID: https://orcid.org/0000-0002-0430-9887)
- Yukio Takahashi (ORCID: https://orcid.org/0000-0001-8506-4289)
- Yasuhiro Fujiwara (ORCID: https://orcid.org/0000-0002-1229-5446)
- Akihiro Ishiguro (ORCID: https://orcid.org/0000-0003-0438-4809)
- Naoyuki Yasuda
- Daisuke Tanaka (ORCID: https://orcid.org/0000-0002-0296-153X)
- Yoichi Kohno
Institutions
- Pharmaceuticals and Medical Devices Agency (JP)
Publication Details
- Journal
- Clinical Pharmacology & Therapeutics
- Published
- 2025-08-04
- DOI
- https://doi.org/10.1002/cpt.70022
- Primary Topic
- Pharmaceutical Economics and Policy
- Type
- article
- Field-Weighted Citation Impact
- 0.00