Pharmaceuticals – Page 6
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JournalThe EMA/NCA electronic product information initiative: Engagement, implementation and vision for the future
This interview with Juan García Burgos discusses the upcoming EMA/National Competent Authority electronic product information (ePI) initiative.
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ContentsSeptember 2025 – Contents
The September issue of Regulatory Rapporteur focuses on product information.
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EditorialReimagining product information
This issue delves into the fundamental role of product information and the processes for its management, and explores how technological advancements are shaping its evolution, with patients’ needs at its core.
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JournalProduct information: An overview
This article gives an introduction to product information, how it is created and managed, and the benefits of transitioning to electronic product information labelling.
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JournalTranslating real-world needs into digital medication tools: Good practices for co-creation with patients
This article discusses the importance of patient engagement in digital health tool development, using the case study of the Gravitate-Health project.
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JournalFDA comparability guidance: The impact of cell and gene therapy products
This article analyses FDA draft guidance and other guidance documents and aims to address concerns about CGT products.
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JournalDiversity in clinical research: Regulatory considerations and updates
This article explores how to improve diversity and patient representation in clinical trials and looks at guidance from the EMA.
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JournalPatient involvement in the regulatory area: Insights into national level dialogues
This article explores the different areas of patient involvement in European NCA regulatory processes.
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JournalThe importance of patient advocacy in the EMA ODD process
This article discusses the role of patient advocacy groups in the orphan drug designation process to incoporate more patient-centred approaches.
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JournalRealising opportunities to generate RWE for regulatory decisions through randomised pragmatic trials
This article summarises key features of the EFPIA paper and discusses how randomised pragmatic trials can be used to aid regulatory decision-making.
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JournalThe evolving landscape of public and patient involvement
This article explores public and patient involvement (PPI) and its impact in shaping national policies.
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ContentsJuly/August 2025 – Contents
The July/August issue of Regulatory Rapporteur focuses on patient involvement.
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EditorialPatient voice: Shaping the future of medicine regulation
This issue looks at the evolving landscape of public and patient involvement (PPI) and how the views of the patient community are being included in research, academia, health and social care and regulatory decision-making.
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Industry newsNHS app opens access to trials for UK patients
This industry news update looks at the NHS app and the opportunities for patients to take part in clinical trials.
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JournalSandbox of trust: Regulated AI for health promotion and disease prevention
This article explores the capacity and potential for AI tools in analysing health data and helping with disease prevention.
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JournalNavigating orphan drug designation in the EU
Orphan drug designation (ODD) is granted to help with the development of treatement for rare diseases. In this article, ODD’s legal framework and its benefits and challenges are explored.
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JournalNavigating the FDA’s platform technology designation: Key insights and best practices for drug manufacturers
This article discusses the platform technology designation (PTD) initiative, including its key elements, challenges and its overall significance.
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JournalPrescribing efficiency: Using generative artificial intelligence for pharmacovigilance
Pharmacovigilance stands as a cornerstone of patient safety but the processes can be arduous. This article explores how generative AI can optimise workflows, reduce reporting burdens and improve timeliness.
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JournalRecent advances and the near-term outlook for Advanced Therapy Medicinal Products in cancer treatment
With ATMPs bringing new promise to the treatment of cancer, this article assesses recent clinical developments, how regulators are responding to these advances and how this will impact patient access in the future.