All Journal articles
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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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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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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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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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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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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 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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JournalWearable technology: The fine regulatory line between health and wellness
This article analyses the distinction between medical devices and ‘lifestyle’ technologies and the regulatory, commercial and ethical considerations created by this form of market positioning.
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JournalFrom design to diversity: Embedding women’s health into medical device innovation and regulation
This article analyses how to integrate women’s health considerations to ensure inclusivity throughout the medical device development lifecycle.
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JournalNavigating regulatory scrutiny: An analysis of requests for information in EU combined clinical trials
This article explores aspects of IVDR and how to implement these during clinical trial processes including submissions.
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JournalParenteral drug delivery systems: Driving clinical success
This article examines the key challenges and best practices in developing parenteral drug delivery systems that pair drugs with specialised devices.
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JournalReckoning with risk: Navigating MedTech innovation
This article discusses different risks within MedTech and how these can be leveraged for innovation and progress.
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JournalDemystifying complex generic products: Regulatory pathways and characterisation
This article explores complex generic products, providing guidance for their definition and classification.
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Journal2025 UK MDR Regulatory Conference: Meeting report
This article is a report of the 2025 UK MDR Regulatory Conference that was hosted by TOPRA and RAPS.
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JournalThe evolving role of the regulatory professional in the age of Artificial Intelligence
This article explores how artificial intelligence can be used across dossier preparation, CMC, clinical development and more.
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JournalEmpowering digital innovation in CMC: A framework for regulatory readiness and confidence
This article looks at the evolution of CMC and technologies, such as AI, to help with applications, regulatory assessments and more.
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JournalRegulatory challenges and key considerations in the development of radiopharmaceuticals
This article looks at CMC, clinical and non-clinical considerations in the development of radiopharmaceuticals.
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JournalOverview of the regulatory and development landscape for brain-computer interfaces in neurodegenerative disease treatment
This article explores brain-computer interfaces (BCIs) for neurodegenerative disease treatments.
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JournalMedical device standards update: December 2025
This article is a continuation of previous updates that share medical device standards up to November 2025.
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JournalBringing innovation to market: Regulatory strategy for MedTech companies
This article explores the ever-changing MedTech landscape and the regulatory strategies to help companies navigate this.