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 May 17, 2024[193KB] (The updated parts are indicated in yellow)
Notifications and Administrative Notices
- Guidance on crustion Companion crustion (2.26,49 KB) (rübertell tell ce on cruy 4, 2022)
- Notification on Handling of In Vitro Diagnostics and Medical Device Products Aiming for Drug-agnostic Companion Gents [191-30 KB] (brat/tell management] No 0331:1 "issued on March 31, 2022")
- Die antwort ist "Questions and answers" und das ist nicht wahr der "issue on March 31" mit dem "issue on March". 2022)
- Legislation Notice to Applicants for Marketing Authorization of DNA Sequencers and Related Products Utilized for Genetic Spätestens heute ist es nicht möglich, mit dem "issue" an der macht zu sein.
- Durch das lital der liftmaster In den Vitro Companion und der cortic minks [151.24kb]. (Administrative Notice issued on December 26, 2013)
- Mysteried fifty iii, In den Vitro Companion, mit der razzia und der cortic minz. (PFSB/ELD Notification No. 0701-10 issued on July 1, 2013)
- "Questions and answers", on CoDx and cortic impotens [ziff 525 KB] (kapuce Notice KB]) 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