Expert comment: Revision of GMP Annex 15 – What does it mean for manufacturers?
5 March 2026 The European Medicines Agency has released a concept paper for revision of GMP Annex 15. Annex 15 is currently intended for used by active substance manufacturers as an optional supplementary guidance to the requirements set out in EudraLex, Volume 4, Part II. However, in June 2020 the report “Lessons learnt from presence […]
Nordic regulatory news highlights February 2026
5 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 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 […]
Swissmedic news highlights February 2026
5 March 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 […]
MHRA regulatory news highlights February 2026
5 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 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 […]
FDA regulatory news highlights February 2026
5 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 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 […]
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) […]
Expert comment: European Biotech Act to strengthen biotechnology and manufacturing sectors
5 February 2026 On 16 December 2025 the European Commission published a proposal for a framework of measures to strengthen the Union’s biotechnology and biomanufacturing sectors particularly in the area of health; the so-called Biotech Act. Background EU has a strong scientific research base in biotechnology but is facing issues with taking the early-stage research […]
Expert comment: China’s strategic shift toward global biopharmaceutical innovation
5 February 2026 Chinese pharmaceutical and biotech companies are increasingly seeking to expand beyond domestic borders, with particular interest in entering European (EU/EEA) markets – an ambition further accelerated by U.S. tariff policies. Over the past two decades, China has rapidly evolved into a global leader in biopharmaceutical innovation, propelled by significant investments in research, […]
Expert comment: EMA recommendations for human medicines in 2025
5 February 2026 The European Medicines Agency has published statistics on human medicines approval from the past year. The full report can be accessed here. New approval recommendations In 2025, 104 new medicines were recommended for marketing authorisation with 38 of these having new active substances not previously authorised in the Union. These numbers are […]
EU regulatory news highlights January 2026
5 February 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 […]