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This article examines the Eurasian Economic Union (EAEU) regulatory pathway following the completion of the transition period in December 2025, after which all medicinal products on the union's market must comply with unified registration rules. It provides a practical guide to the key regulatory institutions, the hierarchy of normative documents, registration procedures, and electronic common technical document (eCTD) dossier requirements. Particular attention is paid to document preparation, common applicant mistakes, and strategies to optimize the regulatory process. The recommendations are based on an analysis of the EAEU regulatory framework and the author’s extensive hands-on experience.

This article discusses how comparability protocols provide structured, pre-approved plans for managing postapproval chemistry, manufacturing, and controls (CMC) changes while ensuring product quality. These protocols explain the scientific rationale for the proposed change, outline the analytical strategy to demonstrate comparability, define the acceptance criteria, and specify the recommended reporting category. The use of comparability protocols aligns with the principles outlined in International Council for Harmonisation (ICH) guidelines, which stress risk-based decision making and strong lifecycle quality management. This article also discusses the advantages and limitations, differences between the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approaches, and practical implementation considerations for comparability protocols.

This article presents a case study outlining the development and submission of a commercial investigational new drug (IND) application for a new chemical entity (NCE) developed at The Ohio State University (OSU). Drawing on their experience as academic drug developers directly involved in the project, the authors describe the regulatory pathway from academic discovery to IND submission. They explore the unique challenges and opportunities for academic drug development and provide valuable insights for other academic institutions embarking on similar paths to an IND submission. Key lessons include the importance of thorough preparation, regulatory strategy, interdisciplinary collaboration, regulatory expertise, and the ability to swiftly respond to feedback.

This article is the first of two on strategic regulatory intelligence for cell and gene therapies (CGTs). It will examine how gaps between product approvals and patient access remain despite significant evolutions in the CGT landscape. Longer approval timelines and increasing product withdrawals underscore the need for robust regulatory intelligence frameworks that integrate geopolitical considerations, real-world evidence (RWE), artificial intelligence/machine learning (AI/ML) tools, and multistakeholder collaboration to build an effective regulatory strategy. The article examines the role of regulatory intelligence in advancing effective regulatory strategy across the full CGT and advanced therapy medicinal product (ATMP) lifecycles, including innovative clinical trial designs, chemistry, manufacturing, and controls (CMC) optimizations, and postauthorization surveillance across major global jurisdictions. The second article explores global CGT pricing and reimbursement models.

This is the second of two articles on cell and gene therapies (CGTs). CGTs are among the most transformative and commercially complex therapeutics with their curative potential and one-time administration model. However, their extremely high research, development, and manufacturing costs create a unique set of regulatory and market access challenges not adequately addressed by the existing frameworks. The article synthesizes comparative regulatory intelligence across five major jurisdictions and discusses the corresponding health technology assessments (HTA), payer expectations, and reimbursement landscapes governing commercial access for approved CGT products. The first article focuses on the role of strategic regulatory intelligence in shaping CGT strategy across the development lifecycle.

This article is the second of two on the EU Artificial Intelligence Act (EU AI Act) and its interaction with the EU Medical Devices Regulation (EU MDR) for AI‑enabled medical devices. The first article focuses on risk classification and the points of convergence and divergence between the two frameworks. Building on that foundation, this article identifies key implementation gaps and proposes ways manufacturers can operationalize EU AI Act obligations using existing EU MDR processes and international standards, including risk management, data governance, transparency, and postmarket monitoring, until CEN-CENELEC harmonized standards and common specifications become available. The article also provides a decision tree to help readers prepare for the phased rollout of EU AI Act implementation.