Expert comment: European Biotech Act to strengthen biotechnology and manufacturing sectors
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 of these products […]
Expert comment: China’s strategic shift toward global biopharmaceutical innovation
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, strong advancements in […]
Expert comment: EMA recommendations for human medicines in 2025
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 slightly lower than […]
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 […]