POLICY AND PRACTICE REVIEWS article
Front. Med.
Sec. Regulatory Science
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1679611
Reimagining Drug Regulation in the Age of AI: A Framework for the AI-Enabled Ecosystem for Therapeutics
Provisionally accepted
- 1Northeastern University - Burlington Campus, Burlington, United States
- 2Northeastern University - Toronto Campus, Toronto, Canada
- 3Northeastern University, Boston, United States
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Artificial intelligence (AI) is increasingly integrated into drug development and regulatory decision-making; however, the regulatory landscape governing these technologies remains fragmented. While agencies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have begun issuing guidance on AI applications in human therapeutics, these frameworks differ substantially in scope, terminology, and application. This lack of alignment complicates regulatory interpretation, creates barriers to regulatory coordination, and impedes equitable access to AI-enabled therapies. In this article, we introduce the AI-enabled Ecosystem for Therapeutics (AI2ET) framework, a conceptual and policy-oriented model designed to support the federation of regulatory knowledge and promote regulatory alignment. The AI2ET shifts regulatory focus from individual AI-generated products to the broader AI-enabled systems, platforms, and processes that underpin drug development. This approach addresses current regulatory gaps in AI oversight by articulating clear definitions of the components that constitute the ecosystem, establishing risk-based decision-making pathways, and finally offering regulatory guidance to navigate the ecosystem. The article offers six key policy recommendations that include strengthening international cooperation, establishing shared regulatory definitions, and investing in regulatory capacity building. By laying down a conceptual foundation for regulatory science-based oversight of AI in therapeutic development, the AI2ET framework offers a path forward for inclusive, effective, and equitable oversight of AI in regulating human therapeutics.
Keywords: artificial intelligence, Drug regulations, Regulatory harmonization, Drug Development, policy, Human therapeutics, Medicines
Received: 04 Aug 2025; Accepted: 22 Sep 2025.
Copyright: © 2025 Singh, Zhou and Auclair. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Rominder Singh, rom.singh@northeastern.edu
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.