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The successful development and deployment of companion diagnostics (CDx) requires effective interactions between four different parties: the therapeutic developer, the diagnostic manufacturer, the drug regulatory body, and the diagnostic regulatory body. Ensuring effective collaboration requires that the parties understand each other's roles, responsibilities, and goals. This article highlights therapeutic, diagnostic, and regulatory perspectives of CDx and emphasizes the importance of open and transparent communication to support successful collaboration and patient access to these critical therapeutic tools.

This article reports the findings from a 2025 benchmarking survey on the adoption of regulatory artificial intelligence (regulatory AI) across pharmaceutical and life sciences industries to learn how regulatory affairs organizations are turning their AI ambitions into action. Industry leaders are investing in AI solutions for regulatory intelligence, drafting assistance, and research assistance, unlocking measurable gains in efficiency, compliance, and insight. Although adoption remains uneven, with many organizations seeking clearer evidence of return on investment (RoI), some are realizing measurable impact. The findings highlight the emerging practices and strategies defining the next era of regulatory excellence and how organizations can improve implementation and scale readiness during the AI revolution.

This article discusses the shift from paper labels to electronic labels and explains how manufacturers and regulators may modify the way important product information is communicated. It examines the status of regional initiatives in the US, Singapore, and the EU; describes the operational and regulatory obstacles to global adoption; and suggests feasible, evidence-based implementation strategies. To achieve a globally harmonized e-labeling ecosystem, the discussion emphasizes the importance of stakeholder collaboration, data integrity, accessibility, and sustainability.

The regulatory affairs (RA) function within the medtech industry is managing an unprecedented surge in compliance complexity and volume, driven by major regulatory shifts like the EU's Medical Device Regulation and In Vitro Diagnostic Regulation and increased guidance from the US Food and Drug Administration (FDA). At the same time, generative artificial intelligence (genAI) has emerged, promising significant efficiency gains: up to a 75% reduction in content creation and billions of dollars in annual productivity savings, according to some sources. This article provides an overview of the role of genAI in regulatory operations, benchmarking model performance in RA-specific contexts, and highlighting key application areas. It also provides practical, actionable guidance for RA professionals and executives on defining robust use cases, securing executive buy-in, essential upskilling, and adopting best practices to ensure the safe, effective, and compliant implementation of genAI.

Welcome to the December issue of RF Quarterly, featuring a selection of articles adapted from presentations at the 2025 RAPS Convergence in Pittsburgh, PA, on 7-9 October. The articles cover global regulatory pathways for orphan medical devices, best practices for effective collaboration around companion diagnostics, e-labeling in drugs and medical devices, and artificial intelligence (AI) in the regulatory setting – specifically, the use of generative AI (gen AI) for scaling up regulatory operations , and survey findings on how regulatory functions are adopting AI

Welcome to the September issue of RF Quarterly, focusing on global regulatory harmonization and including articles on early experiences in implementing version 4 of the electronic common technical document (eCTD v4.0); regulatory reliance in optimizing resources and accelerating patient access to therapies; and harmonization efforts in the medical device setting, specifically, quality standards, postmarket surveillance (PMS), and the role of global organizations in facilitating harmonization.

The International Council for Harmonisation (ICH) has endorsed the eCTD – the electronic common technical document – as the message standard for electronic submissions. This article presents an in-depth analysis of the implementation journey of the eCTD version 4.0 (eCTD v4.0) based on industry involvement in the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the US Food and Drug Administration (FDA) technical pilots. It highlights the importance of harmonizing metadata, managing two different eCTD formats during the transition period, and ensuring interoperability between vendor tools and regulatory systems. Analyses of the eCTD v4.0 specifications are based on the authors' practical experience in submitting sequences in eCTD v4.0 format in Japan, industry involvement in the planning and preparation of eCTD v4.0 implementation, and limited participation during PMDA and FDA technical pilots.

Medical device manufacturers are required to undertake a range of postmarket surveillance (PMS) activities to comply with regulatory requirements to ensure the safety and performance of their devices in the marketplace. This review outlines the requirements for key international jurisdictions and harmonization efforts underway to reduce impediments to market access.

Regulatory reliance allows national regulatory authorities (NRAs) to draw on the scientific assessments and decisions of trusted, more experienced regulators while preserving their sovereign decision-making authority. This approach streamlines approvals, optimizes resources, and expands timely patient access to medicines and medical devices. Reliance also complements harmonization efforts, strengthens regulatory systems, and builds trust among stakeholders. This article provides an overview of reliance principles, highlights global and regional initiatives, and explores their implications for regulatory efficiency and capacity building. By fostering collaboration and mutual trust, regulatory reliance contributes to equitable and improved patient access to medicines and medical devices.

Over the past decade, the global landscape of medical device quality management has undergone a significant transformation. While ISO 13485:2016 provides a common foundation, regional adaptations create overlapping audits and complex compliance pathways. The Medical Device Single Audit Program (MDSAP) and unique device identification (UDI) initiatives have advanced harmonization but remain limited by narrow scopes and database interoperability challenges. Quality management system (QMS) reforms in key markets highlight a growing emphasis on accelerating patient access. This article provides an overview of current quality trends, identifies persistent gaps, and offers a prognosis for future convergence.

Global regulatory harmonization in the medical device sector is essential for ensuring timely patient access to safe and effective technologies while reducing redundant regulatory burdens. This article explores the evolving landscape of harmonization efforts, focusing on the convergence of regulatory frameworks across key markets such as the EU, US, and Asia-Pacific region. It highlights the role of international initiatives such as the International Medical Device Regulators Forum (IMDRF), reliance models, and mutual recognition agreements in shaping a more unified global approach. Furthermore, the article examines how regulatory reliance, streamlined documentation, and shared clinical evidence are being leveraged to accelerate approvals and maintain compliance. It also addresses the challenges of aligning diverse regulatory expectations, particularly in postmarket surveillance (PMS), labeling, and quality system requirements. The discussion underscores the importance of cross-functional collaboration, digital transformation, and proactive engagement with notified bodies and competent authorities, emphasizing the importance of a strategic, risk-based approach to global regulatory operations that balances innovation, patient safety, and market agility.