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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.

Related information

Legislation Notice to Applicants for Marketing Authorization of DNA Sequencers and Related Products Utilized for Genetic Testing Systems (PSEHB/MDRMPED Notification issued on April 28, 2016)

Technical Guidance on Development of In Vitro Companion Diagnostics and Corresponding Therapeutic Products (Administrative Notice issued on December 26, 2013.)

Notification on Approval Application for In Vitro Companion Diagnostics and Corresponding Therapeutic Products (PFSB/ELD Notification No. 0701-10 issued on July 1, 2013)

Questions and answers (Q&A) on CoDx and corresponding therapeutic products (Administrative Notice issued on July 1, 2013.)

  • Discussion paper

Evaluation policy of the companion diagnostics system using next generation sequencing (draft)

Presentation and Publication

Date Presentation Title Place
Nov.2018 PMDA Perspectives on Oncology Panel 15th Annual Meeting, DIA Japan 2018, Tokyo, Japan
Jun.2018 PMDA Perspectives on Companion Diagnostics Development in Japan DIA 2018  Global Annual Meeting, Boston, USA
Feb.2016 Evolving Japanese regulations on companion diagnostics Nature Biotechnology vol.34(2): 141-144 (2016)
Sep.2015 Regulatory Perspective and Challenges Regarding Companion Diagnostics in Japan DIA Companion Diagnostics Conference 2015, Bethesda, USA
Jun.2014 Regulatory Perspective on Co-development of Drugs and Companion Diagnostics in Japan, US and EU DIA 2014 50th Annual Meeting, San Diego, USA
Nov.2013 Points to Consider:Concurrent Development of Companion Diagnostics and Corresponding New Drugs. What are Issues? Where are We? Where are We Going? 10th Annual Meeting, DIA Japan 2013, Tokyo, Japan
Nov.2012 Current Situation of Regulations and Premarket Review in Future of Companion Diagnostics in Japan 9th Annual Meeting, DIA Japan 2012, Tokyo, Japan


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Companion Diagnostics WG