Pharmaceutical Regulatory Authorities – News & Updates (2025)

Every month we check 4 pharmaceutical industry regulatory bodies (the FDA, European Commission, MHRA, and HPRA) and bring together their news into one handy update.

• 16 October – FDA Awards First-Ever National Priority Vouchers to Nine Sponsors
• 23 October – FDA Publishes Filing Checklists to Prevent Submission Delays
• 29 October – FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs
• 31 October – FDA Acts to Protect Children from Unapproved Fluoride Drug Products

• 19 October – Statement by Commissioner Várhelyi ahead of the 30th anniversary of EU medicines approval
• 30 October – New and updated documents – EudraLex Volume 10: Clinical trials guidelines

• 2 October – Sir David Spiegelhalter: Regulation in an age of personalised medicine
• 7 October – UK clinical trial approval times twice as fast with AI and reforms
• 8 October – Patients to benefit as UK and US regulators forge new collaboration on medical technologies and AI
• 10 October – MHRA and NICE invite early adopters to trial accelerated aligned pathway – six months ahead of schedule
• 13 October – Dr Nicola Rose: A new antibiotic is positive news – but it will take more to stay ahead of superbugs
• 14 October –100 years of protecting patients through biological standards for medicines
• 15 October – The new Innovative Licensing and Access Pathway welcomes first investigational products
• 16 October – Professor James Levine: When policy becomes medicine
• 16 October – AI tools that could detect diseases earlier selected for next phase of MHRA’s ‘AI Airlock’ programme
• 22 October – Side effects from drug interactions to be predicted by AI before reaching patients
• 22 October – Government cuts red tape to revolutionise public services with cutting-edge tech
• 24 October – MHRA smashes major illicit weight loss medicine production facility in record seizure
• 24 October – Concizumab approved to prevent or reduce the frequency of bleeding episodes in people aged 12 years and older with haemophilia A or B with inhibitors

• 6 October – Public consultation on proposed fees for 2026: Human Medicines, Compliance Activities, Blood, Tissue Establishments, Organs and Medical Devices
• 6 October – Public consultation on proposed fees for 2026: Veterinary Medicinal Products
  
• 10 October – HPRA health warning after detention of counterfeit tirzepatide pens containing insulin
• 10 October – Prepraring for SoHo – updates on implementation
• 15 October – EU Biotech Act public consultation opens for input
• 15 October – Human Tissues Act – review existing procedures

European Commission – https://health.ec.europa.eu/medicinal-products/latest-updates_en

FDA – https://www.fda.gov/news-events/fda-newsroom/press-announcements

HPRA – https://www.hpra.ie/news-events/news

MHRA – https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency