EU regulatory news highlights November 2025
5 December 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 […]
Nordic regulatory news highlights November 2025
5 December 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 […]
Swissmedic news highlights November 2025
5 December 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 […]
MHRA regulatory news highlights November 2025
5 December 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 […]
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 […]
Expert comment: Swissmedic introduces the Preliminary Decision Clarification Meeting for human medicinal products containing new active substances
6 November 2025 In the course of the regulatory approval process, particularly for innovative products, situations often arise where a close dialogue with the authority is needed or beneficial, e.g. to clarify specific scientific issues or to agree on a certain response strategy to address (major) concerns that the authority has identified. With the newest […]
Expert comment: AI in Pharma – considerations of Annex 22
6 November 2025 Artificial Intelligence (AI) is increasingly being adopted in pharmaceutical industry, offering new opportunities to save time and enhance quality assurance. To ensure these technologies are used responsibly, the European Commission has drafted the new Annex 22 to the EU GMP Guidelines – providing a regulatory framework for AI applications used in the […]
Expert comment: EMA board October meeting highlights
6 November 2025 The EMA management board had its quarterly meeting on 2 October. There were several interesting topics on the agenda. Some highlights are presented below. EMA Mid-year report According to the EMA, reported through their mid-year report, there are less clock-stop extensions which leads to a smoother review process and shorter review times. […]
EU news highlights October 2025
6 November 2025 From the newsfeeds of the European Medicines Agency’s (EMA), the European Commission (EC) and the Head of Medicine Agencies (HMA), Arex Advisor has rounded up a selection of highlights from October 2025. EMA Submission deadlines for Type I variations at the end of 2025 2 October 2025EMA has issued a reminder for […]
Nordic regulatory news highlights October 2025
6 November 2025 From the newsfeeds of the Nordic medical product agencies, Arex Advisor has rounded up a selection of highlights from October 2025. SWEDEN Nordic pilot on English-language medicine packaging expanded 22 October 2025The joint Nordic pilot project on English-language medicine packaging has been extended to allow, in certain cases, the use of English […]