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In the rapidly evolving world of life sciences, merger control and foreign direct investment (“FDI”) regimes have emerged as key...
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On September 12, 2024, the Court of Justice of the European Union (CJEU) delivered a ruling in a case involving Novo Nordisk AS...
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In our earlier article, we discussed the implications of the European Commission’s legislative proposal from 26 April 2023 for the...
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This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click...
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On 18 July 2024 President Von der Leyen laid down the path for the next European Commission in her Political Guidelines for the next...
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Earlier this summer, the Irish Pharmaceutical Healthcare Association (IPHA), which represents the international originator...
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Introduction to the EU Pharmaceutical Reform After the European Commission published the proposed regulation regarding the EU...
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The UK life sciences industry takes centre-stage in two of the new Labour government’s “Five Missions For National Renewal”: economic...
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On April 10, 2024, the European Parliament voted to adopt a revised version of the European Commission’s proposed reforms to...
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Legislative process On 19 July 2022, the European Commission (‘EC’) submitted a proposal for a Regulation on standards of quality and...
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The SoHO proposal introduces the procedure for obtaining an authorisation for SoHO preparations by the introduction of an EU-wide...
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In December 2023, the joint HMA-EMA Big Data Steering Group (BDSG) published a multi-annual (2023-2028) AI workplan to guide use of AI in...
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The World Health Organisation (WHO) has published regulatory considerations on artificial intelligence (AI) for healthcare in October...
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Following the EC’s announcement of the European Pharmaceutical Strategy[1], the Polish government and the country’s business associations...
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Environmental awareness and the desire to limit or eliminate the impact of human activities on the environment have led to real political...
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Introduction The Royal Decree of September 13, 2023 (‘RD’), implementing Article 71bis, § 1, of the Belgian Act on Compulsory Health Care...