Here is our regular summary of content of relevance to neurology from the Human Medicines Highlights – June 2026
Key EMA News Updates:
- Political agreement reached on the Critical Medicines Act
The EMA welcomed the provisional agreement between the European Parliament and the Council of the European Union on the Critical Medicines Act, a key step towards strengthening the security of supply and availability of critical medicines across the EU. Click here for more details: EMA welcomes political agreement on Critical Medicines Act | European Medicines Agency (EMA)
- EMA supports Ebola outbreak response in Africa
The EMA’s Emergency Task Force is collaborating with the African Medicines Agency (AMA) and national regulatory authorities to discuss clinical trial designs and potential medical countermeasures in response to the Ebola outbreak. Click here for more details: EMA, AMA and African regulatory authorities join forces on Ebola outbreak response | European Medicines Agency (EMA)
- EMA monitoring hantavirus outbreak linked to cruise ship
The EMA is closely monitoring the Andes hantavirus outbreak in coordination with EU partners. Based on current evidence, the risk to the general European population is considered very low. Click here for more details: EMA actively monitoring cruise ship Hantavirus outbreak | European Medicines Agency (EMA)
- First report published on EU clinical trial targets
A new report tracks progress towards the EU’s 2030 clinical trial objectives, highlighting early advances in increasing multinational clinical trials and reducing recruitment timelines. Click here for more details: EU tracks progress towards 2030 clinical trial targets | European Medicines Agency (EMA)
- Improvements made to medicine overviews on the EMA website
Feedback from stakeholders has informed enhancements to the EMA’s medicine overview pages, making it easier for users to find relevant information about medicines. Click here for more details: EMA – Improving medicine overviews: what we learnt from our survey
- EMA participates in WorldPride 2026
Under the banner United for Health, the EMA will take part in WorldPride 2026 in Amsterdam, promoting inclusion and equitable access to science and health for all. Click here for more details: United for Health: EMA in WorldPride 2026 | European Medicines Agency (EMA)
Medicines:
- Ontozry (cenobamate)
New liver monitoring requirements for Ontozry (cenobamate) have been introduced by Angelini Pharma S.p.A. in agreement with the EMA, following reports of severe liver injury, including cases of hepatic failure, particularly in patients receiving concomitant antiseizure medications. Ontozry is indicated as adjunctive treatment for focal-onset seizures, with or without secondary generalisation, in adults with epilepsy inadequately controlled despite treatment with at least two antiseizure medications. Click here for more details: direct-healthcare-professional-communication-dhpc-ontozry-cenobamate-new-requirements-liver-monitoring-due-reports-severe-liver-injury_en.pdf
