EU regulatory news highlights May 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 updates marketing authorisation assessment templates to improve efficiency 8 May 2026The European Medicines Agency is updating its marketing authorisation […]
Nordic regulatory news highlights May 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 Six per cent change medicines use following social media advice 4 May 2026A survey by Novus, commissioned by the Swedish Medical Products Agency, found that six per cent of people in […]
Swissmedic news highlights May 2026
From the Swissmedic newsfeed, Arex Advisor has selected the most important regulatory updates from the past month. Swissmedic launches FAST-Track pilot for faster clinical trial reviews 1 May 2026From May 2026, clinical trial applications for category B and C medicinal products approved for accelerated review by Swissmedic will also benefit from expedited assessment by the […]
MHRA regulatory news highlights May 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 consults on updating regulation of gene therapies 11 May 2026The MHRA has launched a consultation on the regulation of gene therapy medicinal products, reflecting advances that increasingly challenge […]
FDA regulatory news highlights May 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 pilots one-day assessments to enhance inspection efficiency 6 May 2026The FDA has launched a pilot programme using one-day inspectional assessments to complement its standard inspection activities. The shorter, targeted […]