Here is our regular summary of content of relevance to neurology from the EMA Human Medicines Highlights – November 2025.
Key EMA News Updates:
- New EMA Booklet on How Medicine Safety Is Ensured in the EU
The EMA has released a booklet titled From laboratory to patients: how the safety of medicines is ensured in the European Union. It explains how the EMA and EU Member States oversee medicine safety at every stage of a product’s lifecycle. The booklet is available on a newly launched webpage dedicated to medicine safety. Click here for more details: Safety of medicines | European Medicines Agency (EMA) - EMA launches #ItTakesATeam campaign on medicine shortages
A new awareness campaign, co-created with partner organisations, highlights the shared responsibility of all actors in preventing and managing medicine shortages and supporting patients. Click here for more details: EMA partners with healthcare professionals and consumers for #ItTakesATeam medicine shortages campaign | European Medicines Agency (EMA) - EU clinical trial map now available in all EU languages
The multilingual clinical trial map provides real-time, patient-friendly information on ongoing clinical trials across the EU and allows queries in lay language. Click here for more details: New clinical trial map launched in the EU | European Medicines Agency (EMA) - Improved scientific advice for medicines targeting public health threats
The EMA’s Emergency Task Force has introduced a strengthened approach that integrates clinical trial and ethics expertise to accelerate development of medicines for emergencies, including those addressing antimicrobial resistance. Click here for more details: Improved scientific advice for medicines for public health threats including antimicrobial resistance | European Medicines Agency (EMA) - EMA completes two mandates as ICMRA chair
EMA Executive Director Emer Cooke concluded her term as chair of the International Coalition of Medicines Regulatory Authorities, passing the role to Anthony Lawler of Australia’s TGA. Click here for more details: ICMRA Summit 2025: EMA concludes its two mandates as chair | European Medicines Agency (EMA)
Public Consultations:
- Concept paper Alzheimer’s disease
The EMA has issued a concept paper outlining the need to update its guidelines on clinical investigations of medicines for Alzheimer’s disease. Comments are open until 28 Feb 2026. Click here for more details: Concept paper on the need for revision of the guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease
Medicines:
- Koselugo (selumetinib)
A new pharmaceutical form consisting of granules in capsules for opening, available in two strengths (5mg and 7.5mg), has been approved. This approval is linked to an extension of the existing indication and covers the treatment of inoperable plexiform neurofibromas in patients with neurofibromatosis type 1 aged 1 year to <7 years, as well as older patients with swallowing difficulties. Click here for more details: Koselugo – opinion on variation to marketing authorisation | European Medicines Agency (EMA) - Hetlioz (tasimelteon)
The CHMP issued a negative opinion on the extension of indication for Hetlioz, which is currently approved for blind patients with non-24-hour sleep–wake disorder. The proposed extension concerned the treatment of night-time sleep disturbances in adults with Smith–Magenis syndrome. Click here for more details: Hetlioz | European Medicines Agency (EMA) - Nurzigma (pridopidine)
The application for Nurzigma for the treatment of adults with Huntington’s disease has been withdrawn. Click here for more details: Nurzigma | European Medicines Agency (EMA) - Risperidone
Several prolonged-release risperidone suspension for injection products (Risperidone Teva, Risperdal Consta, and Sperizak) are currently in shortage across multiple EU Member States. Click here for more details: Risperidone – supply shortage | European Medicines Agency (EMA)
