Author

Shun Masuta

Institution: Pharmaceuticals and Medical Devices Agency

Observed institution: Pharmaceuticals and Medical Devices Agency

ORCID: 0000-0002-2616-7306

Observed ORCID: 0000-0002-2616-7306

OpenAlex ID: A5119609104

Regulatory approaches for platform-based vaccine development in Japan: Insights from PMDA's experience with COVID-19 and RSV vaccines

2026 · Takashi Ogawa, Joo Sunyi, et al. · Vaccine · 2

A platform-based regulatory management of recurrent vaccine composition updates using the Post‑Approval Change Management Protocol (PACMP)—The regulatory framework for seasonal influenza vaccines and COVID-19 vaccines in Japan

2026 · Takashi Ogawa, Tsuyoshi Ando, et al. · Vaccine X

A new Japanese regulatory perspective regarding the indication extrapolation between approved intravenous immunoglobulins (IVIg) products based on comparability assessments of quality attributes

2025 · Takashi Kameda, Kazuki Nagashima, et al. · Biologicals

Works count: 3

Citation count: 2

H-index: 1

I10-index: