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Summary Advocate General Kokott’s Opinion in Case C‑193/25 proposed that the EU Court of Justice annul key parts of Directive (EU)...
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In its detailed judgment of 23 September 2026 in Case T-455/24, the EU General Court firmly established the demanding threshold for...
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The EU Critical Medicines Act (the “Act”) represents an ambitious effort to strengthen the resilience, security and sustainability of the...
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A consultation on the Medicines and Healthcare products Regulatory Authority’s (MHRA) proposed rare disease therapies regulatory...
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Compliance conversations around the European Union’s AI Act have been dominated by its high-risk regime, which was set to take effect...
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Businesses are deploying generative AI tools, large language models (“LLMs”) and, increasingly, “agentic” systems across customer...
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On 20 January 2026, Ropes & Gray’s Global Life Sciences Regulatory & Compliance team hosted the “Life Sciences Regulatory Outlook 2026”...
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In a decision with significant legal and operational ramifications for organisations of all shapes and sizes, the Court of Justice of the...
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Rachel Reeves, the UK’s Chancellor of the Exchequer, has revealed the Government’s Spending Review 2025 (SR25) setting out departmental...
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On May 22, Ropes & Gray and McKinsey & Company co-hosted the 12th Medtech Regulatory Affairs Roundtable online. Around 40 Regulatory...
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Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed,...
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The UK and India have announced one of the “biggest and most economically significant” bilateral trade agreements the UK has signed since...
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Regulation of artificial intelligence (AI) in Asia Pacific remains nascent, mostly governed by existing regulatory frameworks designed...
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Historical development on international trade cooperation on food products Since the early 1960s, countries representing over 99 per...
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Recently, the National Medical Products Administration (NMPA) issued the draft version of 'Implementation Measures for Drug Trial Data...
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The Financial Times recently published a special report on the future of digital healthcare, comprising articles on ‘smart’ hospitals,...