All Regulatory Rapporteur articles in March 2026
View all stories from this issue.
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JournalNavigating regulatory pathways for live biotherapeutics in the US and EU: Challenges and opportunities
This article summarises the current US and EU regulatory landscape for live biotherapeutics and provides practical considerations to help sponsors plan development programmes.
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JournalCell therapy, gene therapy and tissue-engineered product manufacturing: Technical challenges, enablers and regulatory evolution
This article examines the barriers that constrain cell and gene therapy accessibility, discusses emerging solutions and highlights current regulatory expectations
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JournalNavigating Advanced Therapy Medicinal Product regulatory changes: European Medicines Agency and UK guidance updates
This article summarises the implications of the EMA unified guideline, the UK-Post Windsor Framework guidance and proposed revisions to the EU Good Manufacturing Practice Part IV.
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JournalWMA declarations: Helsinki in the spotlight and Taipei in the background
This article examines the role of the Declarations of Helsinki and Taipei in the ethical oversight of research and data and calls for a unified governance framework that integrates participant protection across the entire research lifecycle.
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JournalBeyond product approval: Bridging the gap between regulatory success and patient access for biosimilars
This article examines the post-authorisation barriers for biosimilars through the dimensions of affordability, availability and system readiness and gives recommendations to advance access
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JournalThe EU’s Health Technology Assessment Regulation: Implementation one year on
This article looks at the impact of EU-HTAR on national HTA bodies, developers and patients so far, and discusses what comes next
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JournalTOPRA Annual Lecture 2026: The Global Imperative for Responsible AI in Healthcare
This article summarises the discussions at TOPRA’s Annual Lecture 2026, which focused on the responsible global govenance of AI in healthcare
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EditorialThe innovation era: Where biology meets technology
This issue highlights the rapid evolution of the biologicals landscape and shows why early, transparent regulatory dialogue is now critical to translating scientific breakthroughs into global patient access.
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ContentsRegulatory Rapporteur March 2026 – Contents
The March issue of Regulatory Rapporteur focuses on biologicals.