Entry into force of new European guidelines on marketing authorization fee All news

February 17, 2026

Entry into force of new European guidelines on marketing authorization fee

These new guidelines, which enter into force on 15 January 2026, entail a change in…

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EMA and FDA set common principles for AI in medicine development All news

February 12, 2026

EMA and FDA set common principles for AI in medicine development

EMA and the U.S. Food and Drug Administration (FDA) have jointly identified ten principles to…

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What is the role of a pharmacovigilance service provider? All news

February 10, 2026

What is the role of a pharmacovigilance service provider?

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World Cancer Day All news

February 4, 2026

World Cancer Day

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The Key Role of the QPPV in Europe 💊🛡️ All news

February 3, 2026

The Key Role of the QPPV in Europe 💊🛡️

Within the European regulatory framework, pharmacovigilance is essential to ensure patient safety. At the center…

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Good pharmacovigilance practices All news

January 26, 2026

Good pharmacovigilance practices

The ANSM’s FAQ on Good Pharmacovigilance Practices has recently been updated. This revision introduces several…

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Pharmacovigilance in Clinical Trials 🧪💊 All news

January 6, 2026

Pharmacovigilance in Clinical Trials 🧪💊

Pharmacovigilance plays a critical role throughout the life cycle of a medicinal product, and clinical trials…

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Pharmya wish you a merry Christmas and a happy new year ! All news

December 24, 2025

Pharmya wish you a merry Christmas and a happy new year !

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 December 2025 All news

December 15, 2025

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 December 2025

Seven new medicines recommended for approval; another 12 medicines recommended for extension of their therapeutic…

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 – 27 November 2025 All news

December 4, 2025

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 – 27 November 2025

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities,…

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Signal Management in Pharmacovigilance: Detection and Handling 💊🚦 All news

November 10, 2025

Signal Management in Pharmacovigilance: Detection and Handling 💊🚦

Introduction 🌍 In the pharmaceutical industry, patient safety is the top priority. Pharmacovigilance relies on…

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27 – 30 October 2025 All news

November 3, 2025

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27 – 30 October 2025

Injectable tranexamic acid: serious adverse reactions when inadvertently given intrathecally PRAC agreed on a direct healthcare…

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 September 2025 All news

September 22, 2025

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 September 2025

EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its September 2025 meeting.…

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 September 2025 All news

September 9, 2025

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 September 2025

EMA’s safety committee (PRAC) has started a review of medicines containing levamisole, authorised in four…

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AI and Pharmacovigilance: A Duo Redefining Patient Safety 🤖💊 All news

August 14, 2025

AI and Pharmacovigilance: A Duo Redefining Patient Safety 🤖💊

1. A global and integrated view of safety 🌐🔍 Artificial Intelligence (AI) enables the collection…

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The Fundamentals of Pharmacovigilance: Why Is It Crucial for Patient Safety? All news

July 21, 2025

The Fundamentals of Pharmacovigilance: Why Is It Crucial for Patient Safety?

📌 Introduction Pharmacovigilance is a key medical and scientific discipline essential to public health. Its…

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EMA Management Board: highlights of March 2025 meeting All news

March 17, 2025

EMA Management Board: highlights of March 2025 meeting

At its March meeting, EMA’s Management Board elected Rui Santos Ivo as new chair of…

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ANSM’s involvement in the “Joint Actions” of the “EU for Health” program All news

March 3, 2025

ANSM’s involvement in the “Joint Actions” of the “EU for Health” program

Adopted following the Covid-19 pandemic and established by Regulation (EU) 2021/522 of 24 March 2021,…

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 February 2025 All news

February 14, 2025

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 February 2025

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities,…

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