All Journal articles
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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This article analyses FDA draft guidance and other guidance documents and aims to address concerns about CGT products.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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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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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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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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JournalDivergence on the definition of regulatory reliance in international regions: Is there room for convergence?
The article explores how reliance pathways can be used for MAAs and incorporates AstraZeneca’s research findings on this topic.
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JournalMedical device standards update: May 2025
This article updates the progress of applicable medical device standards to May 2025.
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JournalPromoting the use of bacteriophages in animals to reduce antimicrobial resistance
This article explores bacteriophage-based products for animals and how to reduce antimicrobial resistance (AMR).
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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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JournalNew European Medicines Agency fees: The effect on veterinary medicines
In response to the EMA’s new fee system, this article dicusses the impact on marketing authorisation holders who place veterinary medicines on the market.
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JournalVeterinary Regulation 2019/6: Impact, challenges and the future: Interview with Ivo Claassen
In this interview, Claire McDermott talks with Ivo Classen, Head of the Veterinary Medicines Division and Deputy Executive Director of the European Medicines Agency on the impact of Veterinary Regulation 2019/6.
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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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JournalCase studies: The impact of the In Vitro Diagnostic Regulation on ATMP clinical trials and drug development plans
This article looks at the impact of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and uses case studies to help improve ATMP development.
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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.
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JournalGene Therapy Medicinal Products: An examination of regulatory CMC requirements
This article explores the CMC requirements for GTMPs to help ensure high quality and safe products are brought to market.
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JournalRegulatory governance for medical research in the United Arab Emirates: A comprehensive overview
Since the country’s establishment in 1971, the United Arab Emirates (UAE) has strived for the continual progress and prosperity of the country and its people. This is reflected in the constantly improving research regulatory governance framework that encompasses both federal and local requirements. This article provides a comprehensive overview of the UAE’s research governance structure and highlights its requirements and applicable legislation, both at federal and local levels.