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March 10, 2026
Approximately 5 minutes
Handling of Drug-Agnostic Companion Diagnostics in Japan
1. Background and policy intent
This notification addresses the handling of in vitro diagnostics and medical device products designated as drug-agnostic companion diagnostics (CDx). It builds on previous notifications, such as PFSB/ELD Notification No. 0701-10 (July 1, 2013), and applies under the Act on Quality, Efficacy and Safety Assurance of Pharmaceuticals and Medical Devices (Act No. 135 of 1960). The intent is to enable interchangeable use of multiple CDx products with the same intended use to identify eligible patients for treatment with different therapeutic products, thereby promoting personalized medical therapy and improving patient access to appropriate treatments. Source: https://www.pmda.go.jp/files/000248189.pdf
2. Target products and eligibility types
Drug-agnostic CDx are products meeting three requirements: (1) Multiple CDx approved for the same intended use (target disease, biomarker, specimen type); (2) Different corresponding therapeutic products for each CDx; (3) Scientifically reasonable interchangeable use of test results to identify patients for relevant therapeutics. Eligibility is evaluated case-by-case, considering biomarker characteristics and assay principles. Source: https://www.pmda.go.jp/files/000248189.pdf
3. Consultation pathway before approval
Marketing authorization holders (MAHs) or academic societies propose candidate products using the attached form, submitted to MHLW. PMDA consultation on the proposal's appropriateness is recommended. For new therapeutic products using drug-agnostic CDx, consult PMDA on application strategy during pivotal study planning or approval applications. Source: https://www.pmda.go.jp/files/000248189.pdf
4. Approval application and review expectations
For changing conventional CDx to drug-agnostic: Submit proposal; upon acceptance, PMDA assesses eligibility and issues a report. MAH applies for partial change to modify intended use, adding caution statements to package inserts. For follow-on CDx: Intended use must match approved drug-agnostic CDx. No partial change needed for existing CDx when approving new related therapeutics if adequately justified. Source: https://www.pmda.go.jp/files/000248189.pdf
5. Procedure after approval (post-marketing obligations)
Post-approval, package inserts must include precautions: Follow academic society test guidance; consider product characteristics when selecting assays and interpreting results; base use on thorough knowledge of clinical/analytical performance. Refer to PMDA website for confirmed drug-agnostic CDx applicable to therapeutics. Source: https://www.pmda.go.jp/files/000248189.pdf
6. Practical considerations and positioning versus other pathways
Practically, high concordance in equivalence studies is key for interchangeability. Versus conventional CDx, drug-agnostic allows broader application across therapeutics. Positioning facilitates efficient reviews and personalized therapy. Source: https://www.pmda.go.jp/files/000248189.pdf
7. Effective date
Effective from March 31, 2022. Source: https://www.pmda.go.jp/files/000248189.pdf
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