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 June 19, 2024[193KB] (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
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