Nordic regulatory news highlights January 2026
5 February 2026 From the regulatory newsfeeds of the Nordic medical product agencies, Arex Advisor has rounded up a selection of highlights from the past month. SWEDEN Swedish MPA launches a new operational area for medical devices 7 January 2026Since the turn of the year, the medical devices operational area has been established at the […]
Swissmedic news highlights January 2026
5 February 2026 From the Swissmedic newsfeed, Arex Advisor has rounded up a selection of regulatory highlights from the past month. Revised Annex 7 variation list takes effect from February 2026 6 January 2026An updated list of variations under Annex 7 of the TPLRO has entered into force as of 1 February 2026, reflecting changes […]
MHRA regulatory news highlights January 2026
5 February 2026 From the regulatory newsfeed of the Medicines and Healthcare products Regulatory Agency (MHRA), Arex Advisor has rounded up a selection of highlights from the past month. MHRA explains how borderline products are classified as medicines 6 January 2026The MHRA has set out how it determines whether a product falls within the definition […]
FDA regulatory news highlights January 2026
5 February 2026 From the press releases of the U.S Food and Drug Administration, Arex Advisor has rounded up a selection of regulatory highlights from the past month. FDA signals flexible CMC oversight for cell and gene therapies 11 January 2026The U.S. Food and Drug Administration has outlined a more flexible approach to chemistry, manufacturing […]
Expert comment: EU reaches landmark agreement on pharmaceutical legislation reform
17 December 2025 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 […]
Expert comment: Understanding the new EMA variation requirements
17 December 2025 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 […]
Expert comment: Promotional compliance – major updates in 2025 for the Nordic region
17 December 2025 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 […]
Expert comment: EMA strengthens Scientific Advice process for medicines addressing public health threats
4 December 2025 The European Medicines Agency’s (EMA) Emergency Task Force (ETF) is strengthening its support for the development of promising medicines and vaccines against public health threats by introducing a new procedure for a combined scientific advice (SA) with input from the EMA, as well as clinical trial and ethics experts at national level. […]
Expert comment: FAST-EU: Accelerating clinical trials to boost Europe’s competitiveness
4 December 2025 EU struggles to attract clinical trials The EU’s appeal as a region for conducting clinical trials has declined, with the share of clinical trials sharply dropping over the past decade – from 22% in 2013 to 12% in 2023 (EFPIA 2024). Although progress has been made to reverse this trend through the […]
Expert comment: The new FASS improves user experience
4 December 2025 Fass (FASS) has, since 1966, been the central source of quality-assured pharmaceutical information in Sweden. 25 years ago, Fass went online for the first time. On November 8, the new Fass was launched, marking the most significant update and modernisation since its inception. From book to digital platformFounded in 1966 as a […]