IQVIA’s 2025 safety and regulatory compliance outlook highlights AI as a key driver of efficiency across pharmacovigilance, medical information, and lifecycle management. AI supports CMC variations by automating change control assessments, speeds labeling updates, and cuts costs through OCR, NLP, and neural translation. Regulators are moving toward harmonized, cloud-based submissions and adopting eCTD, accelerating approvals in emerging markets. Local QPPVs remain essential for compliance across regions. Challenges include bias, privacy, and oversight of AI-driven platforms. A risk-based, explainable AI approach with human oversight is expected, balancing innovation with accountability.

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