Artificial intelligence is transforming every corner of the life sciences—and drug development is no exception. What was once theoretical is now tangible, as both regulators and sponsors increasingly turn to generative AI (GenAI) to accelerate innovation, improve efficiency, and strengthen scientific decision-making.
At the 2025 RAPS Convergence in Pittsburgh, experts from leading organizations and agencies shared how AI is reshaping regulatory science—and why companies need to start preparing now.
From Promise to Practice
Generative AI is no longer confined to research labs. The FDA has already reviewed more than 100 submissions that include AI or machine learning components, reflecting how rapidly the technology is being adopted across the drug development lifecycle.
The agency has issued draft guidance outlining a risk-based credibility framework for AI use in regulatory submissions and continues to explore new approach methodologies (NAMs) such as AI-driven toxicity models and organ-on-a-chip systems. These advancements point to a future where data-driven algorithms can complement, and in some cases replace, traditional testing approaches.
However, experts caution that successful integration requires data integrity, human oversight, and validated systems to ensure both safety and reliability. AI’s promise in regulatory contexts depends not only on its capabilities but on the rigor of its implementation.
Global Progress Toward Responsible AI
AI’s influence is not limited to U.S. borders. The European Medicines Agency (EMA) is taking an active role in defining global standards for AI in medicine—both as a regulator and a user. Upcoming EMA guidance on AI in clinical development and pharmacovigilance aims to harmonize expectations across international markets, supporting a consistent approach to oversight and risk management.
By promoting collaboration among global regulators, the EMA hopes to foster innovation without compromising patient safety or public trust—an approach that aligns closely with FDA’s evolving frameworks.
AI in Action: Industry Implementation
Across industry, companies are already deploying generative AI to improve efficiency and compliance. Sponsors are using AI to draft regulatory documents, summarize data, and even flag non-compliant claims before submission.
At organizations like Biogen, AI now assists medical writers with clinical study reports (CSRs) and regulatory submissions, ensuring consistency and speeding up review cycles. These tools act as intelligent collaborators—enhancing productivity while allowing human experts to maintain control and accountability.
Despite the benefits, implementation challenges remain. Data quality, lack of standardization, and a limited talent pool are among the barriers to large-scale adoption. But as experts at Convergence emphasized, the opportunity is too significant to ignore: responsible AI could reduce development timelines, increase transparency, and reshape how new therapies reach patients.
The EMMA International Perspective
At EMMA International, we view generative AI as a pivotal tool in advancing regulatory and quality excellence. When implemented responsibly, AI has the power to optimize submission processes, enhance decision-making, and accelerate innovation—all without sacrificing compliance.
Our team helps clients bridge the gap between technology and regulation by designing data-driven strategies that align with FDA and global expectations. From AI readiness assessments to quality system integration, EMMA International ensures that innovation moves forward with integrity, accountability, and confidence.
As the regulatory landscape evolves, one thing is clear: the future of drug development will not just use AI—it will depend on it.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference:
Craven, J. (2025, October 8). ‘Get ready’ to use genAI in drug development. Regulatory Affairs Professionals Society.
