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
January 17, 2023
Microbiome-Based Therapeutics
Live Biotherapeutic Products; LBPsFebruary 25, 2022
- In preparation