In recent years, the environmental surrounding drug discovery has undergone significant changes, and research and development utilizing technologies fundamentally different from those used in conventional drug development -so-called “new modalities”- has been accelerating. Research and development on new modalities are expected to provide new therapeutic options for various diseases that have been difficult to treat with traditional pharmaceuticals.
PMDA promotes the implementation of new modality pharmaceuticals and contributes to strengthening Japan’s drug discovery capabilities through initiatives such as consultations and support aimed at the practical application of innovate seeds of new modalities.
Related Guidelines, Notifications, and Information
Extracellular Vesicles-Based Therapeutics
- Report on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosome[403KB]
January 17, 2023
Microbiome-Based Therapeutics
Live Biotherapeutic Products; LBPsFecal Microbiota Transplantation; FMT
- Quality of Fecal Microbiota Transplantation (FMT) Products at the Initial Development Stage (Early Consideration) [240KB]
October 31, 2025 Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency
Presentations
Fiscal Year 2025
- Kuribayashi R. Regulatory Updates and a Perspective on Biologics in Japan. CMC Strategy Forum Japan 2025, December 2025[1.96MB]
- Kuribayashi R. Regulatory Perspective on Quality Aspects for Microbiome Medicines in Japan. The 14th APAC, April 2025[1.43MB]
Fiscal Year 2024