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 […]
EU regulatory news highlights March 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 rounded up a selection of highlights from the past month. EMA EMA drafts guidance for microbiome-based medicines development 2 March 2026The EMA has published a draft concept paper to support development […]
Nordic regulatory news highlights March 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 Companies urged to register under NIS2 cybersecurity requirements 4 March 2026Organisations covered by the Cybersecurity Act (NIS2) must register, regardless of sector, following the opening of the notification process in February. […]
Swissmedic news highlights March 2026
From the Swissmedic newsfeed, Arex Advisor has rounded up a selection of regulatory highlights from the past month. Swissmedic aligns biosimilar approach with evolving EU guidance 1 March 2026Swissmedic is aligning its approach to the authorisation of biosimilars with the latest scientific thinking reflected in the EMA draft reflection paper on tailored clinical development. The […]
MHRA regulatory news highlights March 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 clarifies GMP requirements for radiopharmaceuticals in clinical trials 9 March 2026The MHRA has issued guidance on Good Manufacturing Practice for radiopharmaceutical investigational medicinal products used in clinical trials. […]
FDA regulatory news highlights March 2026
From the press releases of the U.S Food and Drug Administration (FDA), Arex Advisor has rounded up a selection of regulatory highlights from the past month. FDA guidance aims to streamline biosimilar development and enable cost reductions 9 March 2026The FDA has issued draft guidance recommending reduced clinical pharmacokinetic testing for biosimilars where scientifically justified. […]