Survey Highlights Critical Need for AI Adoption in Regulatory Affairs Amid Unsustainable Workloads

New research commissioned by ArisGlobal, a provider of life sciences technology solutions, reveals that surging regulatory workloads are forcing life sciences companies to prioritize advanced AI adoption in regulatory affairs (RA). The survey, conducted by Censuswide in September 2024, gathered insights from 100 senior regulatory professionals in U.S. pharma and biopharma companies, emphasizing the need for next-generation technology to maintain regulatory compliance and commercial viability.

The findings show that while AI is essential for tackling inefficiencies and scaling operations, persistent barriers are slowing progress, threatening companies’ ability to efficiently bring treatments to market.

Key Findings from the Study

Workload Challenges: Regulatory workloads are increasing at unsustainable rates, outpacing company growth and overwhelming already stretched teams.
High-Impact Areas: Key regulatory challenges include dossier production, maintaining labeling compliance, data management, document checking, and regulatory impact assessments.
Demand for AI: Ninety-six percent of respondents agree that AI is essential to resolving regulatory bottlenecks.

Popular AI Use Cases in Regulatory Affairs

Respondents showed interest in AI applications across several critical functions, including:

Maintaining labeling compliance and managing deviations
Handling health authority interactions
Translating regulated content for global markets
Enhancing submissions and dossiers
Conducting regulatory impact assessments
Automating submission document creation and summarization
Generating complete regulatory submissions

Barriers to Adoption

While the urgency to adopt AI is clear, respondents noted several barriers:

Outdated IT systems (45%)
Perceived risks vs. benefits (44%)
Concerns about data quality (42%)

However, the study found that budget constraints are less of a concern compared to these perceived issues.

What Could Drive AI Adoption

Regulatory professionals identified key factors that could encourage broader adoption of AI in RA:

Competitors using AI solutions (41%)
Escalating resource pressures (40%)
Maturity and proven effectiveness of the technology (36%)
Availability of task-specific tools (35%)
Improved IT system affordability and ease of use (33%)

Long-Term AI Benefits

Despite current obstacles, the research highlights a consensus among regulatory professionals about AI’s transformative potential:

Forty-eight percent believe AI will streamline routine processes and transform RA workflows.
Forty-three percent say AI will improve the accuracy and quality of submissions.
Thirty-nine percent see AI as vital for keeping pace with market demands.
Thirty-five percent highlight significant time and cost savings through AI adoption.

Expert Insights

Ann-Marie Orange, CIO and Global Head of R&D at ArisGlobal:

“The pressure from regulators to improve product quality and safety is mounting, while the drive to accelerate market access for critical therapies remains a priority. AI has already demonstrated its potential to transform these workflows, and the urgency to adopt it is now undeniable.”

Preeya Beczek, CEO of Beczek.COM:

“AI is coming into its own in life sciences regulatory affairs. Companies that fail to embrace its potential risk falling behind. Stringent regulatory compliance and rapid product approvals require next-generation efficiency, which AI can help achieve.”

The full report, The Imperative to Automate: Unsustainable Regulatory Workloads Leave No Choice About AI Adoption, will soon be available on the ArisGlobal website. It includes detailed findings and practical recommendations for integrating AI into existing IT environments.

Cover photo: tifonimages

Topics: Bioeconomy & Society