Brazil: CIOMS Publishes Guidance on the Use of Artificial Intelligence in Pharmacovigilance

CIOMS (Council for International Organizations of Medical Sciences), an international scientific organization that develops globally recognized guidance and best-practice frameworks in collaboration with the World Health Organization (WHO), published a guidance document addressing the use of artificial intelligence (AI) in pharmacovigilance activities. The guidance provides a structured framework for the responsible, transparent, and ethical application of AI technologies in drug safety monitoring.

The document outlines key principles and considerations for the use of AI across pharmacovigilance processes, including data collection, signal detection, case processing, and benefit–risk evaluation. It emphasizes that AI tools should support pharmacovigilance activities while maintaining appropriate human oversight and full compliance with existing regulatory requirements.

ANVISA’s decision to disseminate this guidance reflects the authority’s interest in promoting alignment with internationally recognized best practices and supporting the responsible adoption of emerging technologies within pharmacovigilance systems. By sharing this update, ANVISA signals the importance of strengthening governance, data integrity, and transparency as AI-enabled tools become increasingly integrated into drug safety activities.

Key Highlights

• Scope of Application
  The guidance covers the use of AI tools in pharmacovigilance activities related to medicinal products and applies across the pharmacovigilance lifecycle, including post-marketing safety surveillance.
• Governance and Oversight
  It emphasizes the need for robust governance frameworks, clear accountability, and validation of AI systems, reinforcing that AI should support—not replace—human decision-making in pharmacovigilance.
• Data Integrity and Transparency
  The guidance highlights the importance of data quality, traceability, and explainability of AI-driven outputs, encouraging transparency in the design, training, and deployment of AI models.
• Regulatory Alignment
  It supports alignment with existing pharmacovigilance regulations and international best practices, serving as a reference point for both regulators and industry to ensure the compliant and ethical use of AI technologies.

This update underscores the growing relevance of artificial intelligence in pharmacovigilance and highlights the need for regulated entities to assess their governance models, data management practices, and oversight mechanisms when considering or implementing AI-based solutions in drug safety operations.