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.

• 3 September – FDA Advances Rare Disease Drug Development with New Evidence Principles
• 4 September – FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch of 89
• 5 September – FDA Launches Green List to Protect Americans from Illegal Imported GLP-1 Drug Ingredients
• 5 September – FDA Approves Expanded Use of Vonvendi for von Willebrand Disease, Including for Certain Uses for Children
• 9 September – FDA Launches Crackdown on Deceptive Drug Advertising
• 10 September – FDA Issues New Guidance to Expand Non-Opioid Options for Chronic Pain, Curb Misuse
• 19 September – FDA Grants Accelerated Approval to First Treatment for Barth Syndrome
• 22 September – FDA Takes Action to Make a Treatment Available for Autism Symptoms
• 22 September – FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy
• 25 September – FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib)
• 25 September – FDA Authorizes Marketing of First Eyeglass Lenses to Slow Progression of Pediatric Myopia

• 3 September – Document summarising evidence supporting the legislative proposal for strengthening the availability, supply and production of critical medicines within the EU
• 3 September – Stakeholders’ Consultation on EudraLex Volume 4 – Good Manufacturing Practice Guidelines: Chapter 1
• 17 September – Commission authorises medicine to treat postpartum depression
• 22 September – Commission publishes new measures for the better lifecycle management of medicine authorisations

• 4 September – Increased risks identified with Profemur cobalt chrome modular neck hip replacements
• 16 September – Vorasidenib approved to treat patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation
• 16 September – Looking to our future: reflections on the strategic choices ahead for the MHR
• 17 September – MHRA and Department for Education embed medicine safety into school curriculum to empower young people
• 17 September – Professor Richard FitzGerald appointed to the Commission on Human Medicines
• 23 September – MHRA confirms taking paracetamol during pregnancy remains safe and there is no evidence it causes autism in children
• 25 September – Millions of vaccines to be made in Oxfordshire, and government unveils £50 million fund, in double boost for life sciences
• 26 September – New Commission to help accelerate NHS use of AI
• 26 September – MHRA and partners unite to reaffirm prescription weight-loss medicine advertising rules
• 29 September – MHRA crackdown on illegal ‘Botox’ after victims left seriously ill

• 3 September – HPRA detains almost 400,000 units of illegal medicines in first half of 2025
• 4 September – Warning about sharp rise in illegal medicines sold in the EU
• 15 September – European campaign promoting responsible use of over-the-counter medicines
• 17 September – HPRA publishes 2024 Annual Report
• 23 September – HPRA statement on use of paracetamol medicines during pregnancy

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