All Regulatory Rapporteur articles in July/August 2026
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JournalEnvironmental risk assessment of human medicinal products in the EU: Legacy APIs, data reuse, and the governance bottleneck after the 2024 guideline revision
The 2024 revision of the EU environmental risk assessment (ERA) guideline extended requirements to all new marketing authorisation applications, including generics and hybrids. This article discusses the obstacles in pharmaceutical ERA, and the implications for regulatory efficiency, environmental protection, ethical use and the potential for improved ERA data reuse.
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JournalAdvancing fertility therapeutics: Scientific, clinical and regulatory challenges in assisted reproduction
This article examines the evolution of fertility therapeutics from urinary-derived gonadotropins to recombinant biologics, and the scientific and operational challenges of fertility drug development. It discusses emerging opportunities across the reproductive pathway and how progress will depend on aligning biological innovation with appropriate clinical endpoints, regulatory frameworks and patient-centred outcomes.
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JournalThe development of novel influenza drugs: Current regulatory challenges
Traditionally, influenza product development has focused on vaccines and antivirals. In recent years, novel approaches including monoclonal antibodies and conjugate products have emerged. This article discusses the current challenges in developing new influenza compounds and the potential regulatory avenues that could support these therapies.
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JournalNavigating the regulatory landscape of adverse events following immunisation: Current challenges and future perspectives
Adverse events following immunisation (AEFI) are a major concern for vaccine safety and public trust. This article examines the current regulatory systems for AEFI surveillance, reporting and causality evaluation, highlights challenges including underreporting and inconsistent frameworks, and assesses how real-world data and advanced analytics could strengthen post-marketing safety surveillance.
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JournalDrug development and regulatory pathways across therapeutic areas
This article evaluates how drug development and regulatory pathways differ across oncology, rare diseases, paediatric indications and life-threatening conditions in the US, UK and EU. Drawing on regulatory guidance and industry practices, it explores how therapeutic context shapes development, trial design and approval strategies, highlighting key differences in regulatory expectations and acceleration incentives.
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JournalMedical device standards update: July 2026
This article is a continuation of previous updates that share medical device standards up to July 2026.
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EditorialTherapeutics: Navigating diverse regulatory pathways
This July/August issue of Regulatory Rapporteur explores how regulatory strategies are shaped by the unique demands of different therapeutic areas. From oncology, rare diseases and paediatrics to influenza, fertility and vaccine safety, we examine the evolving pathways, challenges and opportunities facing product development. Together, these articles highlight the critical role regulatory professionals play in navigating complex and often divergent requirements to support innovation and deliver safe, effective therapies to patients worldwide.
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ContentsRegulatory Rapporteur July/August 2026 – Contents
The July/August issue of Regulatory Rapporteur focuses on therapeutics.