All Regulatory framework articles
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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.