RegASK 2026 Report Reveals Surging Regulatory Pressure Drives AI Adoption In Compliance

KUALA LUMPUR, Nov 19 (Bernama) -- Regulatory pressure is rising at a pace many organisations are struggling to manage, with 83 per cent of regulatory professionals reporting an increase in regulatory volume, according to the 2026 State of Regulatory Affairs and Compliance Report by RegASK.

The report noted a 34 per cent jump from last year, overwhelming legacy systems and leading to costly compliance gaps. Some 37 per cent of regulatory teams said their organisation missed a regulatory requirement in the past year, with half of senior leaders estimating financial losses of between US$500,000 and US$1 million, while 14 per cent reported losses exceeding US$1 million. (US$1=RM4.15)

Based on insights from 162 regulatory professionals and senior leaders across life sciences and consumer product sectors, the study emphasises that regulatory agility has become essential for business growth and resilience, with artificial intelligence (AI) expected to play a defining role, according to a statement.

RegASK Founder and Chief Executive Officer, Caroline Shleifer said AI has become a strategic imperative, adding that AI has evolved from being an emerging opportunity to a strategic capability, but the real challenge is ensuring leadership’s plans and timelines match operational realities.

Despite AI usage doubling over the past year, the report highlights a persistent perception gap between management expectations and operational realities. While senior leadership believes teams can respond to new regulations within a week, frontline staff report a demanding one- to four-week turnaround reliant on manual tracking and limited resources.

This misalignment often pushes teams toward short-term fixes rather than strategic readiness, restricting investment in advanced tools and contributing to burnout. It also explains why 56 per cent of operational teams are turning to general-purpose large language models to address immediate compliance needs.

Adoption of advanced applications such as agentic AI remains limited, with only seven per cent of senior leaders and 16 per cent of operational teams using it, while 39 per cent have never heard of the technology, signalling uneven AI maturity across the sector.

The report shows that just seven per cent of organisations can identify and respond to new regulations within 48 hours, giving them a competitive compliance advantage. In contrast, 16 per cent take more than a month to develop a response plan.

Missing regulatory requirements carries broader consequences, including delayed or cancelled product launches (46 per cent), clinical trial disruptions (39 per cent), product recalls (36 per cent) and reputational damage (25 per cent).

Despite rising demand for automation, most compliance functions remain manual, with 65 per cent relying on newsletter alerts for regulatory updates and 48 per cent depending on dedicated teams to track and interpret changes.

-- BERNAMA