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EMA’s ESMP Training Push Signals More Structured Shortage Reporting
EMA’s new ESMP training session suggests shortage reporting is becoming a more structured and system-driven process for industry.
Today in PV
A quick scan of the latest stories, safety concerns, regulatory developments, and industry signals every pharmacovigilance professional should know today.
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Browse the key areas shaping pharmacovigilance today, from global regulatory updates to safety signals, compliance trends, AI, and career growth.
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Track key developments from FDA, EMA, MHRA, WHO, NAFDAC, Health Canada, TGA, SAHPRA, and other health authorities.
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Stay current on inspection readiness, CAPAs, SOP expectations, audit trends, and the compliance issues shaping PV systems.
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Clear, practical breakdowns of PV concepts, industry terms, reporting frameworks, and regulatory changes.
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FDA Approves Wegovy HD in 54 Days Under Priority Voucher Pilot
FDA has approved Wegovy HD, a higher-dose semaglutide injection, just 54 days after filing under its National Priority Voucher pilot program.
What EMA’s 2026 Biologics Safety Page Signals About Ongoing Regulator Transparency
FDA’s 2026 biologics safety-and-availability communications page is a small but telling sign of how regulators are organizing ongoing public visibility around risk and availability.
Global Watch Weekly: MHRA, EMA Shortages and Veterinary Developments
This week’s global watch includes an MHRA approval with explicit safety follow-up, fresh ESMP activity at EMA, and continued visibility for veterinary regulation.
Week in PV: FDA B6 Warning, GLP-1 Label Change and PRAC Updates
This week’s PV highlights include a new FDA warning for carbidopa/levodopa products, a GLP-1 label reversal, and fresh PRAC visibility from Europe.
Why Real-Time Safety Visibility Is Becoming a Regulatory Strategy
Between AEMS, public dashboards, and standing safety communication pages, regulators are building a more visible safety-information environment.
What the GLP-1 Label Change Says About How Safety Evidence Can De-Escalate
FDA’s move to remove suicidal ideation language from certain GLP-1 labels is a useful reminder that good pharmacovigilance is about following evidence, not just escalating concern.
Featured Posts
What the GLP-1 Label Change Says About How Safety Evidence Can De-Escalate
FDA’s move to remove suicidal ideation language from certain GLP-1 labels is a useful reminder that good pharmacovigilance is about following evidence, not just escalating concern.
CVMP March 2026 Meeting Highlights Keep Veterinary Safety on the Radar
EMA’s March 2026 CVMP meeting highlights are a reminder that pharmacovigilance and regulatory change remain active in veterinary medicines too.
EMA Pushes ESMP Training as Shortage Reporting Matures
EMA’s new ESMP training and ongoing platform guidance show that shortage reporting is becoming a more structured digital capability across Europe.
Why EudraVigilance Training Is a Compliance Control, Not Just Admin
EMA’s approach to EudraVigilance training makes an important point: in regulated PV systems, user competence is part of compliance, not just onboarding.
UK Trial Safety Reporting in 2026: What Inspection-Ready Teams Should Get Right
The UK’s updated clinical-trial framework increases the urgency of getting safety-event collection, verification, and reporting right before implementation goes live.
MHRA Strengthens Warnings for Gabapentinoids, Benzodiazepines and Z-Drugs
This MHRA action shows how regulators use postmarketing evidence not only to assess risk, but to improve how risk is explained, understood, and acted on by both clinicians and patients.
What the FDA’s New AEMS Signal Page Means for Pharmacovigilance Teams
The new AEMS signal page is a reminder that signal detection is not only an internal company activity. It is also a visible regulatory process. Teams that understand what the page is — and what it is not — will be better positioned to interpret FDA safety intelligence correctly.
FDA Warning Letter to Novo Nordisk: What the March 2026 Action Signals for PV Compliance
The FDA issued a warning letter to Novo Nordisk in March 2026 after reviewing compliance with postmarketing adverse drug experience regulations. Here’s why it matters.
What PRAC Safety Signals Mean for Pharmacovigilance Teams
EMA publishes PRAC safety-signal recommendations each month. Here’s what they are, what they are not, and why PV teams should monitor them closely.
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