Artificial intelligence is no longer a theoretical future state in regulatory affairs — it is actively reshaping how pharmaceutical sponsors prepare submissions and how health authorities review them. This DXC report examines the emerging landscape of AI applications across the regulatory lifecycle, documenting both the opportunities for sponsors to improve submission quality and efficiency, and the concrete steps that major global regulatory agencies have already taken to integrate AI into their review processes.
The convergence of these developments signals a fundamental shift in regulatory practice that organizations must understand and prepare for now. In this report, you'll discover more about the changes AI will — and already is — driving, including:
AI applications for sponsors in eCTD submissions
Drug sponsors have significant opportunities to leverage AI to strengthen the quality and compliance of submissions such as electronic Common Technical Documents (eCTDs). AI can identify submission risks before compilation through proactive technical compliance checks — detecting XML, naming and structural errors early, along with validating PDF compliance and hyperlink integrity. Beyond validation, AI supports content readiness during the authoring phase by verifying heading structures, detecting scanned or non-searchable text and flagging inconsistent terminology. These and additional capabilities reduce validation failures, improve document quality and accelerate publishing timelines.
Governance and controlled implementation
The integration of AI into regulatory submissions requires careful governance frameworks that maintain human accountability and transparency. Sponsors implementing AI tools must adopt a human-in-the-loop model where human oversight remains essential throughout the process, and all AI outputs must be explainable and auditable. Critically, compliance accountability must remain with the sponsor, not the AI system. This governance approach ensures that AI serves as a quality enhancer and efficiency tool while preserving the human judgment and regulatory responsibility that regulators expect.
FDA's AI tools in active use
The U.S. Food and Drug Administration has moved beyond pilots into broad implementation, with Elsa — a generative AI tool rolled out agencywide in June 2025 — now supporting FDA staff including scientific reviewers and investigators. Complementing Elsa, CDRH-GPT supports medical device review, while AIM-NASH represents the first FDA-qualified AI tool for clinical research, standardizing liver biopsy scoring in MASH trials. These implementations demonstrate that AI can enhance reviewer efficiency and consistency when properly designed and validated.
Global regulatory agency adoption
Regulatory agencies worldwide are developing or deploying their own AI systems. The European Medicines Agency, for instance, introduced Scientific Explorer in March 2024, enabling EU regulators to efficiently search and extract information from large volumes of regulatory documents using natural language processing. Other countries are exploring or piloting AI-enabled dossier validation systems integrated with their e-governance portals. This global momentum indicates that AI integration in regulatory processes is becoming a standard expectation, and that submission standards and reviewer expectations will evolve accordingly.
Strategic implications and next steps
Organizations in the pharmaceutical and medical device industries should recognize that AI integration in regulatory affairs is accelerating on both the sponsor and authority sides. For example, the transition to eCTD 4.0, combined with widespread agency adoption of AI review tools, creates a window for sponsors to demonstrate submission excellence and operational maturity. Those who prepare early will be positioned to benefit from faster review cycles and stronger relationships with global authorities adapting to AI-enabled workflows.
