Pmda - Pharmaceuticals and Medical Devices Agency

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.


April, 2012


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)

The 11th Symposium on the Industry-Government-Academia Collaborative Forefront Cancer Genome, Tokyo, Janan
December 2023

2019 RAPS Regulatory Convergence, Philadelphia, USA
September 2019