18 Jun, 2024 EU Parliament Adopts Position on Pharmaceutical Reform: Focus on Combating Antimicrobial Resistance By Sarah Faircliffe Caroline Arrighi-Savoie Johanna Harelimana Nour Saab +1 more... Show less On April 10, 2024, the European Parliament voted to adopt a revised version of the European Commission’s proposed reforms to...
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...
27 Feb, 2024 Principle of Automatic Substitution by Biosimilars By Johanna Harelimana Nour Saab Caroline Arrighi-Savoie Like generic medicines, biological medicines that are very similar to another biological medicine (biosimilars) are included in a list...
16 Jan, 2024 HMA-EMA publish multi-annual AI workplan: further guidance on the use of AI in the medicines lifecycle By Hester Borgers 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...
18 Dec, 2023 The Legal 500: Pharmaceutical Advertising Country Comparative Guide 2023 By Sally Shorthose Pieter Erasmus The latest edition of the Legal 500: Pharmaceutical Advertising Comparative Guide is now online. The aim of this guide is to provide its...
24 Nov, 2023 Polish government, business associations respond to EU pharmaceutical law reform By Andrzej Stelmachowski Following the EC’s announcement of the European Pharmaceutical Strategy[1], the Polish government and the country’s business associations...
27 Sep, 2023 Public Procurement for Biological Medicines in Belgium By Lora Arifagic Marc Martens Introduction The Royal Decree of September 13, 2023 (‘RD’), implementing Article 71bis, § 1, of the Belgian Act on Compulsory Health Care...
07 Aug, 2023 Reforming the European pharmaceutical legislation: Shortages of medicinal products By Lora Arifagic Sarah Faircliffe This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...
26 Jul, 2023 What does the European Commission’s proposed reform of EU pharmaceutical legislation mean for Paediatric medicines? By Phillipus Putter Sarah Faircliffe This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...
10 Jul, 2023 Reform of the EU pharmaceutical legislation: proposals to fight against antimicrobial resistance By Sarah Faircliffe Nour Saab Johanna Harelimana This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...
04 Jul, 2023 Increased interest in the use of psychedelics as mainstream therapies By Josh Price Psychedelics have been under investigation by academics, clinicians and pharmaceutical companies for some time and the momentum and...
27 Jun, 2023 Proposed reform of the EU pharmaceutical legislation: New regime for orphan medicinal products under the proposed regulation By Anna Koster Hester Borgers Sarah Faircliffe This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...
23 Jun, 2023 Strengthened Environmental Risk Assessment requirements under the proposed new directive on medicinal products for human use By Emma Stok Hester Borgers Sarah Faircliffe This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...
04 May, 2023 What the replication crisis means for AI and drug discovery By Phillipus Putter Back in May 2016, the scientific publication Nature surveyed over 1,500 researchers to find out how reproducible their work was. This...
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...