Patient Centricity WG

About this WG

This WG looks into topics related to patient engagement into drug and medical device regulations in order to enhance the incorporation of the patient’s voice in activities of PMDA.

Established

May, 2019

Members

Office of Planning and Operations
Office of New Drug I to V
Office of Cellular and Tissue-based Products
Office of Vaccines and Blood Products
Office of Medical Devices I to II
Office of Informatics and Management for Safety
Office of Pharmacovigilance I to II
Office of Review Management
Office of  Regulatory Science Coordination

Document

• Pharmaceuticals and Medical Devices Agency Guidance on Patient Participation (September 7, 2021)[119KB]

Past Presentations (Last 5 years)

• The outlook for Patient involvement in Medical Device Development ~Japanese Regulatory View~[318KB]

Japan-US HBD East 2021 Think Tank Meeting, Web, January 2022

• PMDA’s Patient Participation Activities[0.99MB]

18th DIA Japan Annual Meeting 2021, Web, October 2021