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Pharmaceuticals and Medical Devices Agency (PMDA)

publicPMDA · Japan · Updated Jun 29, 2026

Information Regarding Explanations to Driver Mutations in the Development of Anti-cancer Drugs

Urgency: High

Stakeholders must integrate the new guidance into their signal management and literature surveillance processes to ensure compliance with updated PMDA expectations.

Signal ManagementLiterature SurveillanceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Guidance
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Tag: Pharmaceuticals and Medical Devices Agency (PMDA) | PV Bulletin