Pipeline and approval signals
Search agency notices, approvals, recalls, and regulatory updates from global authorities.
1,100 of 1,100 tracked regulatory updates from 40 agencies and publishers, page 17 of 22.
[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 JapanEntering Clinical Research “Changed the Direction” of ACRP Fellow’s CareerACRP AssociationIndependent Research Sites Don’t Have to Go it Alone to ThriveACRP AssociationInclusive Clinical Trials: How Natural Market Trends and Intentional Operational Pivots Impact Clinical Product Development SuccessACRP AssociationA Cross-Sectional Analysis of Clinical Research Participant SatisfactionACRP AssociationEducating for Trust: Reframing Clinical Research Training for Trial Quality, Digital Governance, and Patient PartnershipACRP AssociationWhy Women Remain Under-Enrolled in Coronary Artery Disease Trials and What Clinical Research Teams Can Do About ItACRP AssociationAre You Ready for a Clinical Trial Inspection Tomorrow?ACRP AssociationEngaging Vulnerable Populations in Research in Trying TimesACRP AssociationBetter Patient Experiences Start Before the VisitACRP AssociationWhen the Patient’s Story Gets Lost: What Clinical Researchers Need to Know About Narrative DistortionACRP AssociationBeyond the Hype: Measuring the Value of AI in Clinical TrialsACRP AssociationWhy Choosing an ISO 27001–Certified Company Matters: 7 Key Benefits for Security, Compliance, and Customer TrustACRP AssociationClinical Research Workforce Attrition is a Planning Failure with a Six-Month DelayACRP AssociationScaling Site Networks: Why Infrastructure Must Keep Pace with GrowthACRP AssociationBeware the “Butterfly Effect” of AI on Privacy and Confidentiality in Clinical TrialsACRP AssociationBeyond Enrollment: Understanding the True Cost of Conducting ResearchACRP AssociationMore Than Representation: Why We Belong in Clinical ResearchACRP AssociationACRP Fellow Advocates for Workforce Support, Recognition of the “Human Element” at the Heart of Clinical ResearchACRP AssociationACRP Unveils Theme for 2027 Annual ConferenceACRP AssociationAll Eyes (Should Be) On Patient Centricity in Clinical ResearchACRP AssociationACRP Launches 2026–27 Scholarship and Grant Application SeasonACRP AssociationMany Different Paths May Lead to a Role in Clinical Project ManagementACRP AssociationTackling the Lingering Questions Surrounding AI Adoption in Clinical Trial SettingsACRP Association