May 08, 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...
Jul 10, 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...
Jun 27, 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...
Jun 23, 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...
Apr 28, 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...
Apr 03, 2023 The Windsor Framework: One Step Closer to a Single UK market By Pieter Erasmus Following the coming into force of the Windsor Agreement on 25 March 2023, we take a look at what this means in practice for the UK...