PMDA exchanges opinions with external experts on issues to be considered in scientific matters.
The Expert Discussion
- The Expert Discussion on developing phage therapy medicinal products for the treatment of antimicrobial resistant bacterial infections (October 2024 to July 2025)
January 15, 2026 PSB/PED Administrative Notice[1.10MB] (in Japanese)
Regulatory considerations for developing phage therapy medicinal products for the treatment of antimicrobial resistant bacterial infections
Fukaya-Shiba A, Ogata A, Kuribayashi R, Sakurai A, Suzuki K, Takadama S, Nishimura J, Uchiyama J, Ohge H, Takeuchi T, Tamaki H, Matsumoto T, Kiga K, Iwano H.
Front Pharmacol. 2025 Dec 18;16:1713471. doi: 10.3389/fphar.2025.1713471.
The Science Board Subcommittees (2012 to 2024)
Drugs
- Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes (August 4, 2021 to September 22, 2022)
- Subcommittee on Microbiome (August 5, 2020 to September 17, 2021)
- Subcommittee on AMR (August 10, 2018 to July 9, 2019)
- Subcommittee on Rare Cancers (October 19, 2016 to October 16, 2017)
- Subcommittee on Pharmaceuticals Development (December 19, 2016 to December 27, 2017)
- Subcommittee on Placebo-controlled Studies (October 3, 2014 to January 14, 2016)
- Subcommittee on Non-clinical Studies (August 4, 2014 to May 13, 2015)
- Pharmaceuticals Subcommittee (September 24, 2012 to February 21, 2014)
- Bio-products Subcommittee (September 24, 2012 to February 21, 2014)
Medical Devices
- Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning (July 26, 2022 to June 19, 2023)
- Subcommittee on Computer Simulation (December 16, 2019 to January 21, 2021)
- Subcommittee on AI (Artificial Intelligence) (January 13, 2017 to October 6, 2017)
- Subcommittee on Application of Numerical Analysis to Non-clinical Evaluation (August 4, 2014 to March 1, 2016)
- Subcommittee on Evaluation of Medical Devices in Pediatric Use (October 17, 2014 to October 19, 2015)
- Medical Devices Subcommittee (September 24, 2012 to February 17, 2014)
Regenerative Medical Products
- Subcommittee on Cell and Gene Therapy Products Produced in vivo (June 1, 2023 to May 23, 2024)
- Subcommittee on Genome Editing (November 8, 2018 to October 29, 2019)
- CPC (Cell Processing Center) Subcommittee (June 12, 2014 to May 14, 2015)
- Cellular and Tissue-based Products Subcommittee (September 24, 2012 to February 3, 2014)