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

• Updated September 24, 2024[194KB] (The updated parts are indicated in yellow)

Notifications and Administrative Notices

• Guidance on Drug-Agnostic Companion Diagnostics[226.49KB] (Administrative Notice issued on July 4, 2022)
• Notification on Handling of In Vitro Diagnostics and Medical Device Products Aiming for Drug-agnostic Companion Diagnostics[191.30KB] (PFSB/ELD Notification No. 0331-1 issued on March 31, 2022)
• Questions and answers (Q&A) on Drug-agnostic Companion Diagnostics[209.85KB] (Administrative Notice issued on March 31, 2022)
• Legislation Notice to Applicants for Marketing Authorization of DNA Sequencers and Related Products Utilized for Genetic Testing Systems[106.41KB] (PSEHB/MDRMPED Notification issued on April 28, 2016)
• Technical Guidance on Development of In Vitro Companion Diagnostics and Corresponding Therapeutic Products[151.24KB] (Administrative Notice issued on December 26, 2013)
• Notification on Approval Application for In Vitro Companion Diagnostics and Corresponding Therapeutic Products[51.56KB] (PFSB/ELD Notification No. 0701-10 issued on July 1, 2013)
• Questions and answers (Q&A) on CoDx and corresponding therapeutic products[55.25KB] (Administrative Notice issued on July 1, 2013)

Discussion paper

• Evaluation policy of the companion diagnostics system using next generation sequencing (draft)[172.96KB]

Presentation and Publication (Last 5 years)

• Quality Control of Software as a Medical Device for Genomic Testing[520KB]

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

• PMDA Perspectives on CDx[1.20MB]

2019 RAPS Regulatory Convergence, Philadelphia, USA
September 2019