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26 Mar 2026

Industry calls for synchronized implementation of ICH M4Q(R2)

The Pharmaceutical Research and Manufacturers of America (PhRMA) has stated that the ICH M4Q(R2) involves a significant restructuring of the quality section of the Common Technical Document (CTD), bringing major changes for both the industry and regulators. As such, ICH and regulatory authorities should promote global synchronization of the guideline’s implementation to reduce the need for maintaining dual dossier structures.

Regulatory News
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06 Mar 2026

Regulatory considerations for pharmaceutical excipient selection

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.

Journal
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06 Mar 2026

Journal of Regulatory Affairs: March-April 2026

Welcome to the Journal of Regulatory Affairs, featuring in-depth coverage of the EU Artificial Intelligence Act (EU AI Act) as well as articles on engineering safety and effectiveness in drug-device combination products and regulatory considerations for pharmaceutical excipient selection. These articles are exemplary of the mission of this new journal. They provide readers with valuable, evidence-based information on emerging issues in global healthcare regulation that can be used as guidance or a reliable resource in their daily regulatory work. They also flag the importance of companies, agencies, and professionals ensuring they are future-ready.

Journal
Member Only
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06 Mar 2026

Engineering safety and effectiveness: A first-principles approach to drug-device combination products

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.

Journal
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