Expert comment: EU reaches landmark agreement on pharmaceutical legislation reform
On 11 December 2025, the Council of the EU and the European Parliament concluded negotiations on the long-awaited reform of the EU pharmaceutical legislation, marking the most significant overhaul in over two decades. The provisional agreement represents a major milestone in shaping the future of the EU regulatory framework for pharmaceuticals. Background First proposed by […]
Expert comment: Understanding the new EMA variation requirements
Long-awaited variation updates The recently updated EMA variation requirements reflect a major revision of both the legal framework and its practical guidance. It is essential to understand the distinct roles of the legally binding Variation Regulation and the accompanying EMA Variation Guideline, as well as the key drivers behind their revision and the practical implications […]
Expert comment: Promotional compliance – major updates in 2025 for the Nordic region
With 2025 coming to a close, we have seen several important updates to Nordic promotional compliance codes over the past year. This overview highlights the key developments affecting promotional activities in the Nordics and outlines their implications for pharmaceutical and healthcare stakeholders. Sweden – LER update On 29 September 2025, LIF’s ethical rules for the […]
Arex Advisor summary of 2025 highlights
17 December 2025 For Arex, 2025 was defined by expansion, both in geographical footprint and in expertise. Above all, we are proud to support our clients on their important projects. Now, we look forward to continuing our journey! https://arexadvisor.com/wp-content/uploads/2025/12/Arex-year-highlights-2025-1.mp4 Are you looking for regulatory support? Our experienced specialists are ready to help you navigate the […]