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Welcome to the Pharma.ai Blog, your source for expert perspectives on artificial intelligence, pharmacovigilance, drug safety, regulatory compliance, and digital transformation in the pharmaceutical industry.

EU Pharmacovigilance Regulation 2025/1466: Key Reforms for MAHs

Commission Implementing Regulation (EU) 2025/1466 brought a seismic shift in regulatory expectations on February 12, 2026. This has transformed how pharmacovigilance outsourcing is governed across the European Union. It’s not just another compliance regulation; it has reshaped vendor management, data privacy and operational transparency. This solidifies the oversight of outsourced PV activities...

How is literature screening evolving in 2026 with AI and automation?

Pharmacovigilance teams with manual literature screening find the process extremely exhausting and time-consuming. Regulatory bodies like EMA, FDA, and MHRA have noticed this and enforced regulatory standards for efficient and automated literature screening. With these bodies pressing MAHs (Marketing Authorization Holders), literature screening has become a critical compliance frontier where...