Expert comment: EMA strengthens Scientific Advice process for medicines addressing public health threats
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. The overall goal […]
Expert comment: FAST-EU: Accelerating clinical trials to boost Europe’s competitiveness
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 implementation of the […]
Expert comment: The new FASS improves user experience
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 printed book for […]
EU regulatory news highlights November 2025
From the regulatory newsfeeds of the European Medicines Agency’s (EMA), the European Commission (EC) and the Heads of Medicine Agencies (HMA), Arex Advisor has rounded up a selection of highlights from November 2025. EMA EMA outlines its role in ensuring medicine safety 6 November 2025The European Medicines Agency explains how it evaluates medicines for safety, […]
Nordic regulatory news highlights November 2025
From the regulatory newsfeeds of the Nordic medical product agencies, Arex Advisor has rounded up a selection of highlights from November 2025. SWEDEN Sweden tightens rules to improve safety of home-delivered medicines 7 November 2025The Swedish Medical Products Agency (Läkemedelsverket) has introduced new rules for distance sales to ensure that home delivery of medicines is […]
Swissmedic news highlights November 2025
From the Swissmedic newsfeed, Arex Advisor has rounded up a selection of regulatory highlights from November 2025. Swissmedic reports on 2022–2024 GCP clinical trial inspections 6 November 2025Swissmedic has published its latest review of Good Clinical Practice inspections, covering activity between 2022 and 2024. The regulator conducted 114 inspections across 139 drug studies, providing oversight […]
MHRA regulatory news highlights November 2025
From the regulatory newsfeed of the Medicines and Healthcare products Regulatory Agency (MHRA), Arex Advisor has rounded up a selection of highlights from November 2025. Expert highlights key principles for regulating AI in healthcare 19 November 2025Professor Alastair Denniston sets out core principles to guide how artificial intelligence should be regulated as it becomes increasingly […]
FDA regulatory news highlights November 2025
5 December 2025 From the press releases of the U.S Food and Drug Administration, Arex Advisor has rounded up a selection of regulatory highlights from November 2025. FDA Awards Second Batch of National Priority Vouchers 6 November 2025The FDA has awarded six additional vouchers under its Commissioner’s National Priority Voucher pilot, bringing the total to […]