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 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.

This article discusses the role and importance of excipients in medicines, focusing on regulatory aspects crucial for pharmaceutical companies. The aim of the article is to provide an overview of regulatory considerations in excipient selection and management, elucidating the complex landscape companies must navigate.

The European Medicines Agency (EMA) oversees the centralized marketing authorization procedure for medicinal products across the EU. While this procedure provides a single authorization valid throughout the EU, country-specific requirements must still be met. This article examines key regulatory requirements for registering and maintaining EU-authorized medicines in Spain. It explores the registration steps and marketing authorization holder (MAH) responsibilities, including labeling, pharmacovigilance, anticounterfeiting measures, pricing and reimbursement, and requirements for promotional materials. The article provides practical insights into navigating the Spanish regulatory landscape within the broader EU framework, offering regulatory professionals a comprehensive guide to facilitate successful market access and ongoing compliance.

Representative enrollment is crucial for credible benefit-risk assessments and the external validation of clinical evidence. Despite evolving terminology and policies, the need for clinical trial populations to reflect the intended US patient population remains. This article discusses a practical framework for regulatory planning, highlighting scientific rationale, operational levers, enabling technologies, real-world evidence, and approaches for sustaining momentum amid changing policies. The article offers actionable insights for embedding representation throughout the product lifecycle while maintaining validity and feasibility.

This article presents a comparative analysis of the regulatory requirements for convenience kits and procedure packs in the US and EU, with an emphasis on classification criteria, labeling and unique device identifier (UDI) requirements, and registration obligations. The article examines the regulatory framework for convenience kits in the US and compares it with the applicable requirements under the EU Medical Devices Regulation (EU MDR) and related guidance documents from the Medical Device Coordination Group (MDCG). The article also highlights regulatory considerations and offers practical insights into navigating both markets. A comprehensive understanding of these regulatory considerations is crucial for facilitating compliant market entry and optimizing global distribution strategies.

The 2025 edition of the Chinese Pharmacopoeia (CPh) of the People's Republic of China includes systematic revisions and improvements across a range of entries. A key aim of the Chinese Pharmacopoeia Commission is to continually harmonize the ChP with other international pharmacopoeias. This article examines that approach, using the example of human plasma to produce blood products and including comparisons with the US Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur.).

This article examines how technology can be leveraged to expand direct-to-consumer access to medications under the US Food and Drug Administration's (FDA) new regulatory pathway, which took effect in May 2025. Driven by unmet patient medical needs, shortages of healthcare professionals (HCPs), and technological advancements that can help reduce barriers to treatment, the FDA has introduced a new incremental NDA pathway that allows sponsors to propose alternative mechanisms to support appropriate medication access without the supervision of an HCP legally authorized to prescribe or administer the drug. This pathway has important potential benefits for branded prescription medicines, generic manufacturers, consumer healthcare companies, and most importantly, consumers or patients.

This article provides a detailed examination of the evolution of the framework for predetermined change control plans (PCCPs) in the US from concept to implementation and its emergence as a potential global standard. Building on perspectives shared by regulatory, legal, and technical experts, it analyzes key elements of two recent US Food and Drug Administration (FDA) guidance documents for PCCPs for artificial intelligence-enabled device software functions and for all medical devices. The article further explores best practices for drafting and maintaining PCCPs across the total product lifecycle and considers their strategic implications for manufacturers and regulators.

The new EU Clinical Trials Regulation represents the most significant overhaul of clinical trial requirements in Europe for a generation, and this article describes the insight gained during the months following the implementation of this new regulation. The article reviews the implications for sponsors, describes the experiences and lessons learned of an organization submitting many clinical trial applications during this time, and looks to the near future as the regulation becomes fully established.

The global regulatory profession is facing a shift in the definition of leadership success. This article aims to shed some light on important aspects of leadership. In the context of the article, leadership is defined as the power of making a difference. It explains why critical thinking, business acumen, emotional intelligence, team building, influence, and mentorship play a vital role in building leaders and why regulatory professionals should use these tools to become successful leaders.