11 Sep, 2024 EU Pharmaceutical Reform: Update on the proposed changes to marketing authorisation procedures By Sally Shorthose Sophie Vo This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click...
08 May, 2024 SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin - interplay with the ATMP Legislation By Marc Martens Lora Arifagic Legislative process On 19 July 2022, the European Commission (‘EC’) submitted a proposal for a Regulation on standards of quality and...
07 May, 2024 Italy: Originator to pay over €13.4 million for abusing its dominant position by misusing the patent system By Evelina Marchesoni In this article we look at a ground-breaking decision of the Italian Supreme Court dealing with the compensation for damages caused by an...
30 Apr, 2024 Developments in the Netherlands on preventing unwanted influence of healthcare professionals by medical companies By Hester Borgers Jephta Zantinge On 8 April 2024, the Dutch Minister of Medical Care (the Minister) sent a letter to the Dutch House of Representatives (Kamerbrief)...
12 Jul, 2023 Code of practice introduced for holding cultivated meat tastings By Emma Stok Sander Wagemakers Hester Borgers Nicolas Carbonnelle +1 more... Show less Particularly in the Netherlands, developments in the field of cultivated meat have succeeded each other rapidly over the past years....
28 Apr, 2023 Revamping the European pharmaceutical industry: A closer look at the EU’s proposed legislative framework By Marc Martens Lora Arifagic Kevin Munungu Lungungu On 26 April 2023, the European Commission published the long-anticipated proposal for the revision of the pharmaceutical legislative...
26 Apr, 2023 Single-arm clinical trials: EMA launches consultation By Phillipus Putter In contrast to randomised controlled trials (RCTs), single-arm clinical trials (SATs) are relatively simple by design: a sample of...