Regulatory Rapporteur March 2026 – Contents
Regulatory Rapporteur
March 2026 | Vol. 23 | No. 3
Write to the Editor at publications@topra.org
The March issue of Regulatory Rapporteur focuses on biologicals.
Contents:
- Editorial: The innovation era: Where biology meets technology
- Focus: Navigating regulatory pathways for live biotherapeutics in the US and EU: Challenges and opportunities
- Focus: Cell therapy, gene therapy and tissue-engineered product manufacturing: Technical challenges, enablers and regulatory evolution
- Focus: Navigating Advanced Therapy Medicinal Product regulatory changes: European Medicines Agency and UK guidance updates
- Focus: Beyond product approval: Bridging the gap between regulatory success and patient access for biosimilars
- Standalone: The EU’s Health Technology Assessment Regulation: Implementation one year on
- Standalone: WMA declarations: Helsinki in the spotlight and Taipei in the background
- Standalone: TOPRA Annual Lecture 2026: The Global Imperative for Responsible AI in Healthcare
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