Nordic regulatory news highlights February 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 Proposals aim to ease patient access during medicine shortages 17 February 2026In its final report on measures to prevent and manage supply and shortage situations, the Swedish Medical Products Agency presents […]
Swissmedic news highlights February 2026
From the Swissmedic newsfeed, Arex Advisor has rounded up a selection of regulatory highlights from the past month. Swissmedic reports rise in illegal medicine imports in 2025 16 February 2026Swissmedic recorded a 17% increase in illegal medicinal product imports in 2025 compared with 2024, handling 6,647 consignments in collaboration with the Federal Office for Customs […]
MHRA regulatory news highlights February 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 pharmacovigilance expectations under updated CIR 520/2012 9 February 2026The MHRA has issued updated guidance for UK Marketing Authorisation Holders on the application of revised pharmacovigilance provisions set […]
FDA regulatory news highlights February 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 revises policy on ‘no artificial colors’ claims 5 February 2026The FDA has introduced a new approach allowing food companies to label products as containing ‘no artificial colors’ if […]
EU regulatory news highlights February 2026
5 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 CHMP sets priorities in 2026 workplan 2 February 2026The Committee for Medicinal Products for Human Use (CHMP) […]
EU regulatory news highlights January 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 and FDA agree principles for trustworthy AI in medicines 14 January 2026The European Medicines Agency and the U.S. Food […]
Nordic regulatory news highlights January 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 Swedish MPA launches a new operational area for medical devices 7 January 2026Since the turn of the year, the medical devices operational area has been established at the Swedish Medical Products […]
Swissmedic news highlights January 2026
From the Swissmedic newsfeed, Arex Advisor has rounded up a selection of regulatory highlights from the past month. Revised Annex 7 variation list takes effect from February 2026 6 January 2026An updated list of variations under Annex 7 of the TPLRO has entered into force as of 1 February 2026, reflecting changes adopted under Articles […]
MHRA regulatory news highlights January 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 explains how borderline products are classified as medicines 6 January 2026The MHRA has set out how it determines whether a product falls within the definition of a medicinal […]
FDA regulatory news highlights January 2026
From the press releases of the U.S Food and Drug Administration, Arex Advisor has rounded up a selection of regulatory highlights from the past month. FDA signals flexible CMC oversight for cell and gene therapies 11 January 2026The U.S. Food and Drug Administration has outlined a more flexible approach to chemistry, manufacturing and control requirements […]