Pipeline and approval signals
Search agency notices, approvals, recalls, and regulatory updates from global authorities.
31 of 1,114 tracked regulatory updates from 40 agencies and publishers.
[SHINSA]Basic Principles for the Use of AI in Regulatory Activities（Early Consideration） posted.PMDA Japan[KOKUSAI]PMDA-ATC Learning Videos contents have been updatedPMDA Japan[ANZEN]PMDA Alert for Proper Use of Drugs: Request for Proper Use of GLP-1 Receptor Agonists and GIP/GLP-1 Receptor Agonists postedPMDA Japan[SHINSA]English Translation of Review Report: ZurzuvaePMDA Japan[ANZEN]PMDA Risk Communications: Tapinarof,etc. postedPMDA Japan[ANZEN]Revisions of PRECAUTIONS: Inclisiran sodium,etc.postedPMDA Japan[IBENTO][IBENTO]Report of PMDA-ATC GMP Inspection Seminar 2026PMDA Japan[SHINSA]List of Approved Regenerative Medical Products: April 2015 to July 2026PMDA Japan[SHINSA]SaMD page updated (English translation of “Review Points for Medical Devices Utilizing Generative AI (Draft)” published, consultation schedule updated)PMDA Japan[SHINSA]Information on biosimilars is updatedPMDA Japan[YAKKYOKUKATA]Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updatedPMDA Japan[SHINSA]The new website “Overview of SAKIGAKE Designation“ launched.PMDA Japan[SHINSA]The English versions of GMPGCTP Annual Report FY 2025 have been published.PMDA Japan[KOKUSAI]PMDA-ATC Training Materials have been updatedPMDA Japan[ANZEN]MHLW Pharmaceuticals and Medical Devices Safety Information No.431 postedPMDA Japan[KOKUSAI]“For Industry - for development in Japan “ Updated.PMDA Japan[SHINSA]"Consultations" UpdatedPMDA Japan[IBENTO][IBENTO]Report of PMDA-ATC Generic Drugs Review Seminar 2026PMDA Japan[KOKUSAI]PMDA Updates (2026 No.3) postedPMDA Japan[REGYURATORISAIENSU]Regulatory Science Activity Report updatedPMDA Japan[IBENTO][IBENTO]PMDA-ATC MRCT/GCP Inspection Seminar 2027 applications openPMDA Japan[SHINSA]CDx approved for identifying eligible patients (Updated)PMDA Japan[YAKKYOKUKATA]Implementation of PDG harmonized texts into Japanese Pharmacopoeia (Monographs) updatedPMDA Japan[SHINSA]List of Approved Medical Devices: April 2004 to December 2025PMDA Japan[SHINSA]English Translation of Review Report: remedē SystemPMDA Japan[IBENTO][IBENTO]Report on the PMDA Hokuriku Branch 10th Anniversary SymposiumPMDA Japan[YAKKYOKUKATA]JP Drafts (September 2026) Part 1 postedPMDA Japan[YAKKYOKUKATA]JP Drafts (September 2026) Part 2 postedPMDA Japan[SHINSA]English Translation of Review Report: Akuugo (Partial Change Approval)PMDA Japan[IBENTO][IBENTO]Report of PMDA-ATC & U.S. FDA Pediatric Review Seminar 2026PMDA Japan[SHINSA]One-Stop Service Platform by ENSEMBLExJ page updatedPMDA Japan