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EMA outlines AI, real-world evidence...

The European Medicines Agency (EMA) has published...

EMA and national competent authorities:...

An announcement referring to an "EMA inspection"...

EMA outlines AI, real-world evidence and regulatory changes in EU pharmacovigilance

The European Medicines Agency (EMA) has published the outcomes of its 21st Industry Stakeholder Platform on the Operation of EU Pharmacovigilance Legislation, held on 20 October 2026. The discussions covered artificial intelligence (AI) in safety monitoring, the expansion of the DARWIN EU real-world evidence network, EudraVigilance reporting performance and upcoming revisions to Good Pharmacovigilance Practices (GVP). Several developments have direct implications for marketing authorisation holders, particularly regarding signal monitoring, periodic safety reporting and risk management plans. AI applications move into pharmacovigilance pilot deployment EMA presented two AI-enabled initiatives currently in pilot...
TOP-Pharma Editorial Team -
Regulatory Affairs

EMA outlines AI,...

The European Medicines Agency (EMA) has published the outcomes of its 21st Industry Stakeholder Platform on the Operation of EU Pharmacovigilance Legislation, held on...
TOP-Pharma Editorial Team -
Inspection Readiness

EMA and national...

An announcement referring to an "EMA inspection" does not necessarily mean that EMA inspectors will visit your manufacturing site. The European Medicines Agency (EMA)...
TOP-Pharma Editorial Team -
Pharma

EMA opens consultations...

The European Medicines Agency (EMA) has opened two public consultations on the methodology of confirmatory platform trials and the quality of adverse drug reaction...
TOP-Pharma Editorial Team -
Documents

AI in drug...

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have jointly developed Guiding principles of good AI practice in drug...
TOP-Pharma Editorial Team -
Pharma

European Commission grants...

The European Medicines Agency (EMA) is set to enhance pharmaceutical regulation across Africa, backed by a significant €10 million grant from the European Commission....
TOP-Pharma Editorial Team -
Regulatory Affairs

AI in drug...

2024 sees a pivotal moment in AI-driven drug development with diverse global stances. This piece delves into the potentials, key details, and unique features of AI in pharmaceuticals.
TOP-Pharma Editorial Team -
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