Expert comment: EMA board October meeting highlights
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. All in all, […]
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 […]
Swissmedic news highlights October 2025
6 November 2025 From the Swissmedic newsfeed, Arex Advisor has rounded up a selection of highlights from October 2025. Swissmedic to introduce Clarification Meeting after preliminary decisions 1 October 2025Following a successful pilot launched on 1 June 2024, Swissmedic will formally introduce the Clarification Meeting procedure for human medicinal products on 1 October 2025. The […]
MHRA news highlights October 2025
6 November 2025 From the newsfeeds of the Medicines and Healthcare products Regulation Agency, Arex Advisor has rounded up a selection of highlights from October 2025. UK cuts clinical-trial approval timelines with AI and reforms 7 October 2025The Medicines and Healthcare products Regulatory Agency (MHRA) has reduced average approval times for clinical trials in the […]
FDA news highlights October 2025
6 November 2025 From the press releases of the U.S Food and Drug Administration, Arex Advisor has rounded up a selection of highlights from October 2025. FDA awards first-ever National Priority Vouchers to nine sponsors 16 October 2025The Food and Drug Administration (FDA) has announced the first recipients of its new Commissioner’s National Priority Voucher […]