All Regulatory Rapporteur articles in June 2026
View all stories from this issue.
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JournalThe use of CEPs for API registration when global regulatory implementation pathways are not aligned
Drawing on interviews with experienced regulatory professionals, this article identifies the non-technical competencies associated with advancement to leadership roles and calls for a rethink of the approach to developing these skills.
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JournalNavigating divergence: Practical lessons from the UK lifecycle management of licences
Four case studies demonstrate how marketing authorisation holders can optimise UK lifecycle strategy through the strategic use of national routes, the International Recognition Procedure and parallel submissions, despite increasing EU-UK regulatory divergence.
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JournalDriving efficiencies in global submissions through RIMS: Practical perspectives from industry
Manual processes are holding many teams back. Using a case study on complex EU procedures, this article explores how RIMS can help build future-ready regulatory functions.
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JournalFrom gatekeepers to collaborators: Regulatory evolution toward risk-based lifecycle approaches in an era of innovation
Rapid advances in AI, software and drug discovery are reshaping regulation. This article challenges the view that regulation hinders innovation, framing it as a collaborative, risk-based partnership with real-world examples from AI diagnostics, in silico methods and medical device tools.
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JournalConsiderations in building and maintaining regulatory intelligence
Rising regulatory volume, cross-jurisdictional variation and resource pressures make regulatory intelligence increasingly critical. Explore how AI and technology can support smarter monitoring, planning and risk management.
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JournalEnhancing post-market surveillance with Artificial Intelligence and predictive analytics
Fragmented data and manual review can limit the impact of PMS. Find out more about how AI, can modernise PMS workflows to improve early issue detection and support corrective actions, using a 20-year analysis of arthroscopic-device recalls to illustrate predictive analytics in practice.
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EditorialLifecycle management: Enhancing regulatory agility
Navigating complex regulatory requirements across multiple regions and dealing with fragmented data are common challenges for keeping marketing authorisations and technical files compliant. This June issue of Regulatory Rapporteur looks at how AI and advanced digital technologies can help by integrating data and generating predictive insights, enabling more proactive lifecycle management and time for innovation.
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ContentsRegulatory Rapporteur June 2026 – Contents
The June issue of Regulatory Rapporteur focuses on lifecycle management.
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CommentaryMedical Device Regulation 2.0: Why stakeholder disagreement is bad for all
Proposals for MDR 2.0, published in December 2025, have exposed deep divisions across the EU medical devices community. This thought leadership article argues that, without genuine stakeholder consensus and structural reform, history risks repeating itself, with serious consequences for patients and industry alike.