All Regulatory Rapporteur articles in April 2026
View all stories from this issue.
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JournalThe regulatory valuation of patient experience data in rare diseases: A review of FDA and EMA labelling outcomes and methodological determinants
This article summarises a review carried out to evaluate patient experience data inclusion in regulatory assessements and labelling for rare diseases in the EU and the US
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PodcastsRegRapPod − InConversation with Magda Papadaki
InConversation talks portfolio careers with Magda Papadaki and Ming Ewe
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JournalPlain language results in UK clinical trials: Navigating new regulatory requirements and practical challenges
This analysis examines the new regulatory requirements for providing plain language summaries of trial results to participants, outlines operational challenges and offers practical recommendations for compliance with the HRA’s transparency framework.
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JournalBeyond borders: Strengthening regional regulatory frameworks to end substandard and falsified medicines in Africa
This analysis examines the regulatory, economic and supply chain dynamics underpinning the issue of substandard and falsified medicines in Africa, and explores how regional harmonisation initiatives, emerging technologies and strengthened enforcement mechanisms can protect public health across the continent
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JournalThe strategic role of Regulatory Operations in digital transformation success
This article discusses how Regulatory Operations is evolving from document-centric gatekeeper to data-driven strategic partner, and uses a case study from Syneos Health to show how its RegOps team led an initiative to deploy GenAI tools for patient narratives, CMC extraction and plain language summaries
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JournalEmergency use authorisation of in vitro diagnostic devices by the US FDA: The regulatory framework, lessons from COVID-19 and future directions
This article explores the FDA’s Emergency Use Authorisation framework and its aim to speed up the deployment of IVDs during public health emergencies, focusing on its evolution, operational mechanisms and significance in public health preparedness.
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JournalRegulatory affairs as a strategic function in market access of medicinal products: Pre‑COVID-19 context, COVID-19 acceleration and post‑COVID-19 convergence across 11 markets
This article looks at how regulator, HTA body and payer interfaces have evolved since the COVID-19 pandemic and how regulatory affairs has become a strategic integrator of regulation, evidence and access
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JournalLean Six Sigma in post-market surveillance: Insights for EU 2017/745 MDR Article 88 and Great Britain SI 2024/1368 (44ZN) trend reporting compliance
This article demonstrates how Lean Six Sigma principles can strengthen post-market surveillance systems for medical devices, enabling manufacturers to detect statistically significant trends in non-serious incidents and meet evolving EU MDR Article 88 and UK SI 2024/1368 44ZN requirements through structured DMAIC methodology and statistical process control
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EditorialAccess to medicines: From approval to
patient-centred deliveryThis issue focuses on access to medicines, and demonstrates how lifecycle regulation, diverse evidence, operational innovation and corss-sector collaboration all contribute to improving the timely, equitable and trusted delivery of medicines.
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ContentsRegulatory Rapporteur April 2026 – Contents
The April issue of Regulatory Rapporteur focuses on access to medicines.