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 introduces a first-principles, systems-engineering framework for assuring safety and effectiveness in drug-device combination products. It critiques siloed, compliance-driven practices in pharmaceutical and device development and advocates integrated, purpose-driven decision making grounded in patient needs, intended use, and engineering principles. By unifying design controls, quality by design, risk management, and structured justification frameworks, it connects the dots for safety and effectiveness and establishes safety engineering as a discipline that transforms compliance into demonstrable, lifecycle-based assurance of safety and effectiveness in combination products.

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.

Understanding global regulatory guidelines and requirements for chemistry, manufacturing, and controls (CMC) is crucial in developing cellular and gene therapies (CGTs). While the FDA and the EMA share similarities, key differences exist. This article examines the similarities and differences in the regulation of raw and starting materials, process validation approaches, comparability requirements, and considerations involving medical device compatibility for cell and gene therapy development. Understanding these nuances is vital when targeting both markets, enabling informed decision making and aligned strategies throughout development.

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.