PV Watch Daily Blog
Fresh reporting, analysis, and expert insight on drug safety, regulatory developments, safety signals, inspections, AI in pharmacovigilance, and career trends.
EMA Pushes ESMP Training as Shortage Reporting Matures
EMA’s “What’s new” page lists a new event for European Shortages Monitoring Platform (ESMP) training on readable IDs and general updates for industry dated 20...
What the New AEMS Signal Page Means for Safety Intelligence Teams
FDA says that when a potential signal of a serious risk is identified from AEMS data, it will be posted in the required quarterly report in the quarter in...
Why Real-Time Safety Visibility Is Becoming a Regulatory Strategy
FDA says AEMS is its new Adverse Event Monitoring System, and the agency also maintains a dedicated page for new safety information or potential signals of...
What the GLP-1 Label Change Says About How Safety Evidence Can De-Escalate
FDA says its comprehensive review of available data did not identify an increased risk of suicidal ideation or behavior with GLP-1 RA medications and...
EMA’s PMS FAQs Show Where Product Data Friction Still Exists
EMA’s Product Management Service FAQs, updated in January 2026, collect questions raised during PMS events and are intended to complement those sessions. EMA...
MHRA’s National Assessment Procedure Update: Why It Matters in 2026
MHRA updated its National assessment procedure for medicines guidance on 24 February 2026, setting out the agency’s UK national route for marketing...
Why MHRA’s 30-Day Type II Safety Variation Route Matters
MHRA’s variations guidance says a reduced Type II procedure, shortened from 60 days to 30 days, is available for some safety-related variations when agreed...
What MHRA’s February 2026 Safety Roundup Signals for Drug Safety Teams
MHRA’s Safety Roundup: February 2026 pulls together recent medicines and device safety information, including semaglutide-associated NAION and falsified...
MHRA Highlights Very Rare NAION Risk with Semaglutide
MHRA says non-arteritic anterior ischemic optic neuropathy (NAION) has been very rarely reported with semaglutide and has updated product information for...
MHRA’s National Assessment Procedure Update: Why It Matters in 2026
MHRA’s National assessment procedure for medicines guidance was updated on 24 February 2026. The page explains the agency’s national assessment procedure for...