All Regulatory Rapporteur articles in December 2025
View all stories from this issue.
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EditorialNorth America: Transparency, transformation and innovation pathways
This issue focuses on North America, with articles centring on developments in both the US and Canada. It also presents multiple articles on the topic of medical devices and technology.
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Journal2025 Regulatory Intelligence Conference Europe: Meeting report
This article summarises sessions from the TOPRA/RAPS 2025 Regulatory Intelligence Conference Europe.
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JournalBridging the digital divide: A toolkit for equity-centred regulation of digital mental health
This article offers an overview of a proposed toolkit to support regulators and developers in embedding equity into digital mental health technology workflows.
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ContentsRegulatory Rapporteur December 2025 – Contents
The December issue of Regulatory Rapporteur focuses on North America.
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JournalFrom laboratory to patient: The role of New Substance Notifications in delivering innovative therapies in Canada
This article explores the new substance notification (NSN) processes and provides guidance on navigating this.
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JournalCross-functional strategies in clinical data disclosure for EMA Policy 0070 and Health Canada PRCI
This article discusses the requirements of clinical data transparency particularly in relation to the EMA Policy 0070 and HC PRCI.
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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.
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JournalA year of change for the US FDA: An update on notable pilots and programmes
This article updates on the FDA’s pilots and programmes that have been launched and also ongoing projects in 2025.
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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.