In 2025, AI became an increasingly fundamental component of enabling efficiency and reducing resource burden across pharmacovigilance (PV), safety, and regulatory workflows. Now, sponsors must prepare for compliance in this new era by designing rigorous approaches to AI governance and risk-based validation, training teams to understand and interact symbiotically with AI, and prioritizing collaboration with regulators.

How did safety and regulatory workflows evolve in 2025?

The embrace of AI has yielded a number of surprising outcomes, including:

• Rapid regulatory acceptance and greater transparency around regulatory criteria for AI integration.
• A cultural shift among process owners and CROs who have quickly adapted to this new technology and are now proposing ways to enhance it.
• Greater recognition of medical information as a source of strategic, real-world insights from patients, HCPs, and caregivers.

These factors will inform the next wave of AI integration across PV and safety processes.

Key strategies for AI governance and compliance

As this culture evolves, it is vital to build thorough AI governance structures to ensure regulatory compliance. The following strategies will help secure that AI tools are safe, reliable, and effective:

1. Maintain a human in the loop across all workflows. AI is meant to augment human expertise, not function as an autonomous decision maker. To ensure AI outputs are accurate, human experts should remain close to the reporting to apply smart touch approaches.
2. Elevate AI proficiency. Train PV, safety, and regulatory staff to improve their AI understanding, enhance their technical skill sets, and use critical thinking across AI processes. Bringing these solutions to the table requires technology experts, process experts, and those who can bridge the gap.
3. Standardize for global compliance. Design AI tools that are dynamic across global regulatory frameworks and languages, mapping new guidance to internal SOPs to enable cross-regional functionality.
4. Prioritize risk-based validation. Leverage a risk-based approach to validation that considers the technology being implemented, the existing process, what functions it touches, and the context of use. The FDA’s draft guidance on AI in drug development encourages such an approach.
5. Engage with regulators early and often. Participate in the FDA’s Emerging Drug Safety Technology Program, where sponsors can present their AI approach to regulators for feedback prior to implementation.

These initial strategies lay the groundwork for AI governance and compliance. However, as new AI use cases emerge, sponsors, vendors, and regulators must continue to learn, collaborate, and adapt to meet the needs of the moment.

Ready to learn more?

In a recent panel discussion, some of IQVIA’s leading experts across PV, regulatory strategy, analytics, and product safety shared their predictions and recommendations for safety and regulatory workflows in 2026. To prepare for the year ahead, download the white paper: Safety & regulatory predictions and trends for 2026.