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Regulatory Science/The Science Board/Standard Development

Companion Diagnostics WG

About this WG

The purpose of this WG is to discuss regulatory issues related to CoDx and a corresponding therapeutic product.  The WG contributes to the development of relevant notifications and administrative notices issued by MHLW.

Established

April, 2012

Members

Office of Medical Devices I
Office of In Vitro Diagnostics
Office of New Drug I to V
Office of Cellular and Tissue-based Products
Office of Pharmacovigilance I to II
Office of Review Management
Office of Manufacturing Quality and Vigilance for Medical Devices
Office of Regulatory Science Coordination

Related information

List of approved CDx in Japan


Notifications and Administrative Notices


Discussion paper

Presentation and Publication (Last 5 years)

2019 RAPS Regulatory Convergence, Philadelphia, USA
September 2019

 

15th Annual Meeting, DIA Japan 2018, Tokyo, Japan
November 2018

 

DIA 2018  Global Annual Meeting, Boston, USA
June 2018