EU regulatory news highlights April 2026
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 selected the most important regulatory updates from the past month. EMA EMA and Health Canada align clinical data publication through work-share initiative 20 April 2026The EMA and Health Canada have introduced […]
Nordic regulatory news highlights April 2026
From the regulatory newsfeeds of the Nordic medical product agencies, Arex Advisor has selected the most important regulatory updates from the past month. SWEDEN Updated AI guidance for Swedish healthcare published 8 April 2026The Swedish MPA has released an updated version of its AI guidance for healthcare, with new content focusing on considerations and risks […]
Swissmedic news highlights April 2026
From the Swissmedic newsfeed, Arex Advisor has selected the most important regulatory updates from the past month. Swissmedic publishes FAQs on risk management for medicines 1 April 2026Swissmedic has introduced a new set of frequently asked questions covering key requirements and procedures for the risk management of human medicinal products. The resource complements existing guidance, […]
MHRA regulatory news highlights April 2026
From the regulatory newsfeed of the Medicines and Healthcare products Regulatory Agency (MHRA), Arex Advisor has selected the most important regulatory updates from the past month. MHRA sets expectations for environmental risk assessments of medicines 1 April 2026The MHRA has published guidance outlining requirements for environmental risk assessments for medicinal products in the UK. The […]
FDA regulatory news highlights April 2026
From the press releases of the U.S Food and Drug Administration (FDA), Arex Advisor has selected the most important regulatory updates from the past month. FDA urges sponsors to disclose missing clinical trial results 13 April 2026The FDA has reminded more than 2,200 sponsors and researchers of their obligation to submit clinical trial results to […]