A recent report from RegASK reveals a significant increase in regulatory volume, overwhelming existing systems and leading to substantial financial losses for companies that miss compliance requirements, underscoring the urgent need for regulatory agility driven by artificial intelligence.
The “2026 State of Regulatory Affairs and Compliance Report,” compiled by RegASK, indicates that 83% of regulatory professionals observed an increase in regulatory volume, marking a 34% surge from the previous year. This rising pressure is overwhelming traditional systems, leading to critical consequences. Over one-third (37%) of regulatory teams surveyed reported missing a regulatory requirement in the past year. Among these, 50% of senior leaders estimated financial losses between US$500,000 and US$1 million, with 14% reporting losses exceeding US$1 million. Based on insights from 162 regulatory professionals and senior leaders globally across the life sciences and consumer product industries, the report emphasizes that regulatory agility is now essential for business growth and resilience, with AI playing a crucial role.
While the usage and demand for AI have doubled in the past 12 months, a gap persists between leadership expectations and the operational realities of frontline teams. Most senior leaders anticipate their teams can respond to new regulations within a week, but the reality for operational teams involves a demanding one- to four-week process, often relying on manual tracking, reactive fixes, and limited resources. This misalignment can lead teams to prioritize immediate solutions over long-term preparedness, limiting investment in advanced tools and resulting in missed deadlines, team burnout, and a continuous cycle of catching up. Consequently, 56% of operational teams are utilizing general-purpose large language models (LLMs) to address immediate compliance challenges, rather than waiting for enterprise-wide rollouts.
Caroline Shleifer, Founder and CEO of RegASK, stated, “AI has evolved from being an emerging opportunity to a strategic capability. But the real challenge isn’t deciding to adopt AI. It’s making sure leadership’s envisioned plans and timeline matches the reality of what operational teams actually need. That alignment is what enables effective AI adoption and true regulatory agility.”
Adoption of advanced applications like agentic AI remains nascent, with only 7% of senior leaders and 16% of operational teams actively using it today. Furthermore, 39% of respondents have never heard of the technology, indicating that AI maturity is still developing across regulatory teams.
The report’s key findings highlight several trends. Only 7% of organizations can identify a new regulation and execute a response plan within 48 hours, providing a first-mover advantage, while 16% of teams take more than a month to respond. The cost of missing a regulatory requirement extends beyond financial losses, with 46% of senior leaders facing delayed or canceled product launches, 39% experiencing clinical trial disruptions, 36% having product recalls, and 25% suffering brand reputation damage. Despite growing regulatory volume and interest in AI, most compliance teams still rely on manual workflows; 65% depend on newsletter alerts from regulators or aggregators, and 48% rely on dedicated teams to manually track updates. However, AI adoption is gaining momentum, with 27% of organizations now using vertical AI platforms to track regulatory changes, a 42% increase from 19% last year.
The report outlines a clear progression for the function, projecting that over the next three years, Regulatory Affairs will transform from a reactive cost center into a strategic command function, driven by AI-powered insights, cross-functional integration, and human oversight. As AI handles more execution tasks, human expertise will shift to focus on judgment and strategy, requiring teams to develop new skills such as AI literacy, oversight and quality assurance of AI outputs, and ethical reasoning.
Amenallah Reghimi, RegASK’s Chief Product and Technology Officer, commented, “The data is clear. The focus has shifted from wanting AI to operationalizing it, and the future belongs to the augmented team where humans lead and AI enables. The goal is not to replace experts, but to free them from low-value work so they can focus on what truly moves the business forward. This is Augmented Intelligence in action, and it’s defining the new era of regulatory excellence.”
RegASK is an AI-driven platform that provides end-to-end regulatory intelligence and workflow orchestration. It automates regulatory intelligence through curated content, actionable insights, and workflow automation, while connecting a global community of over 1,700 subject matter experts for streamlined compliance execution. By combining Agentic AI efficiency with deep regulatory expertise, RegASK aims to empower organizations in proactively managing compliance and navigating complex regulatory landscapes.
