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EMA outlines AI, real-world evidence...

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

Japan’s PMDA sets out principles...

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)...

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 -
Regulatory Affairs

Japan’s PMDA sets...

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a set of principles for the responsible use of artificial intelligence in regulatory activities. The...
TOP-Pharma Editorial Team -
Pharma

UK announces AI...

The UK government has announced the establishment of the AI Biosecurity Lab (AIBL), a dedicated organisation intended to use advanced artificial intelligence (AI) to...
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 -
Manufacturing

FDA, Sanofi and...

At the 2026 PDA/FDA Joint Regulatory Conference, representatives from the US Food and Drug Administration (FDA), Sanofi and Gilead Sciences discussed how pharmaceutical manufacturers...
TOP-Pharma Editorial Team -
Medical Devices

WHO issues AI...

The World Health Organization (WHO) published guidance on 18 January 2024 on the ethics and governance of large multi-modal models (LMMs), a form of...
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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