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CMDh publishes Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs
May 7, 2026
CMDh publishes Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs
Occasionally, it may not be possible to finalise an issue (e.g. a signal or a…
What if how you feel after taking a medication really mattered?
After taking a medication, you may notice something unusual: extreme tiredness, headaches, rashes, nausea… 👉…
Product Management Service (PMS) – Frequently Asked Questions (FAQs)
The European Medicines Agency (EMA) has published a list of frequently asked questions (FAQs) collected…
💊 Every report matters. Every signal counts
April 23, 2026
💊 Every report matters. Every signal counts
Behind every medicine, there’s continuous monitoring to ensure safety for all. From rare side effects…
EMA publishes detailed guidance on electronic submission of authorized medicines
The European Medicines Agency (EMA) has published detailed XEVPRM user guidance on the electronic submission…
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2026
April 17, 2026
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2026
The meeting highlights were published. PRAC agrees on communication to inform healthcare professionals that cases…
Behind each safe medication, there is a PV expert who analyses, prevents and protects
April 16, 2026
Behind each safe medication, there is a PV expert who analyses, prevents and protects
🔍 Discover the crucial role played by our experts at Pharmya, 🛡️ And how they…
EMA’s Data Protection Notice for the exchange of information during the Critical Medicines Vulnerability Assessment exercise
April 9, 2026
EMA’s Data Protection Notice for the exchange of information during the Critical Medicines Vulnerability Assessment exercise
The European Medicines Agency (EMA) has published a Data Protection Notice explaining the details of…
Social Media and Pharmacovigilance 📱💊
March 31, 2026
Social Media and Pharmacovigilance 📱💊
In the digital age, social media has become an essential tool for healthcare professionals and…
World Tuberculosis Day : a major public health and pharmacovigilance challenge
🌍 World Tuberculosis Day : a major public health and pharmacovigilance challenge 🦠 Tuberculosis…
NDSG Workplan 2026-2028: Data and AI in medicines regulation
March 23, 2026
NDSG Workplan 2026-2028: Data and AI in medicines regulation
Following the first workplan adopted in March 2025, the joint HMA/ EMA Network Data Steering…
Discover Pharmya – Your Partner in Pharmacovigilance
March 18, 2026
Discover Pharmya – Your Partner in Pharmacovigilance
Ensuring drug safety and regulatory compliance is essential in today’s healthcare landscape. At Pharmya, we…
EU implementation strategy of ICH E2D (R1) Guideline – post approval safety data: definitions and standards for management and reporting of individual case safety report
The European Medicines Agency (EMA) has published the ICH E2D (R1) guidelines, which comes officially…
Understanding EudraVigilance
March 5, 2026
Understanding EudraVigilance
💊 What is EudraVigilance? EudraVigilance is the European pharmacovigilance database 📊. It collects and…
A few key numbers
March 3, 2026
A few key numbers
Growth. Quality. Expertise. 🚀✨ Here’s a snapshot of our journey:
Rare Disease Day
February 27, 2026
Rare Disease Day
Rare Disease Day – 28 February 2026 🌍 Every year on 28 February, Rare Disease…
Final training module issued for ICH guideline E2B (R3)
February 24, 2026
Final training module issued for ICH guideline E2B (R3)
ICH has published Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs), Module…


