All Regulatory framework articles
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JournalNavigating the regulatory landscape of adverse events following immunisation: Current challenges and future perspectives
Adverse events following immunisation (AEFI) are a major concern for vaccine safety and public trust. This article examines the current regulatory systems for AEFI surveillance, reporting and causality evaluation, highlights challenges including underreporting and inconsistent frameworks, and assesses how real-world data and advanced analytics could strengthen post-marketing safety surveillance.
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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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JournalMD3/IVD3: A global snapshot – Non-EU regulatory updates for medical devices and IVDs
This is a report of the MD3/IVD3 session that took place at this year’s Symposium.
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JournalAn overview of the regulatory framework for advanced therapies
Advanced therapy medicinal products (ATMPs) have recently advanced in development and are subject to regulation in some markets. This article summarises the regulatory framework for ATMPs in some of the markets where these requirements are in place: Argentina, Brazil, Europe, and the US.