Companion Diagnostics

Links to major regulatory information of Companion Diagnostics（CDx）.
 

Regulations and Notifications

Drug-Agnostic Companion Diagnostics

• Partial revision of "Guidance on Drug-Agnostic Companion Diagnostics"[209KB]

May 22, 2024 Administrative Notice

 

• Guidance on Drug-Agnostic Companion Diagnostics[226.49KB]

July 4, 2022　Administrative Notice

 

• Notification on Handling of In Vitro Diagnostics and Medical Device Products Aiming for Drug-agnostic Companion Diagnostics[191.30KB]

March 31, 2022　PFSB/ELD Notification No. 0331-1

 

• Questions and answers (Q&A) on Drug-agnostic Companion Diagnostics[209.85KB]

March 31, 2022　Administrative Notice

Companion Diagnostics

• Revision of "Points to consider for application for approval of drugs to be administered based on specific biomarkers that were developed by investigator-initiated clinical trials in patients with rare cancer"[172KB]

March 19, 2024 PSB/PED Notification No. 0319-1・ PSB/MDED Notification No. 0319-1

 

• Technical Guidance on Development of In Vitro Companion Diagnostics and Corresponding Therapeutic Products[151.24KB]

December 26, 2013　Administrative Notice

 

• Notification on Approval Application for In Vitro Companion Diagnostics and Corresponding Therapeutic Products[51.56KB]

July 1, 2013　PFSB/ELD Notification No. 0701-10

 

• Questions and answers (Q&A) on CoDx and corresponding therapeutic products[55.25KB]

July 1, 2013　Administrative Notice

Genetic Testing Systems

• Legislation Notice to Applicants for Marketing Authorization of DNA Sequencers and Related Products Utilized for Genetic Testing Systems[106.41KB]

April 28, 2016　PSEHB/MDRMPED Notification

Related Links

• Please click here for list of approved CDx in Japan.