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EMA EMA 2025 AI Observatory Report: Artificial Intelligence in Medicines Regulation
Artificial Intelligence (AI) is rapidly becoming an integral part of pharmaceutical development and regulatory operations. From drug discovery and clinical trials to manufacturing and pharmacovigilance, AI is transforming how medicines are developed, assessed, and monitored. The European Medicines Agency (EMA) published its 2025 AI Observatory Report to provide an overview of AI-related activities across the European Medicines Regulatory Network (EMRN). The report highlights

Sharan Murugan
Jun 63 min read


MDCG Med Dev Guidance: Interplay between MDR & IVDR and the Artificial Intelligence Act
On June 19, 2025, the Medical Device Coordination Group (MDCG), in collaboration with the Artificial Intelligence Board (AIB) of the...

Sharan Murugan
Jun 29, 20253 min read


New EU Regulations on AI in Medical Devices: Key Insights and Implications
The European Union has published the finalized text of the Artificial Intelligence Act (AIA) which is a significant step forward in...

Sharan Murugan
Jul 15, 20242 min read
