Our summary of neurological news items from the European Medicines Agency (EMA) January 2025 Human Medicines Newsletter.
The European Medicines Agency (EMA) released its January 2025 “Human Medicines Highlights” newsletter, covering several key developments:
Transparency and Data Protection: EMA, in collaboration with the Heads of Medicines Agencies (HMA), has updated its guidance on identifying commercially confidential information and personal data in marketing authorisation applications, reinforcing their commitment to transparency. Please click here for more information.
Health Technology Assessment (HTA): The EU regulation on HTA became applicable on 12 January 2025. EMA will support its implementation, focusing on joint clinical assessments, joint scientific consultations, and horizon scanning. Please click here for more information.
Competing Interests Policies: Revised policies on handling competing interests for scientific committee members, experts, and Management Board members have been published, effective from May 2025. Please click here for more information.
Electronic Product Information (ePI): A pilot project on ePI indicates that the EU regulatory system is prepared for its adoption, although further development is needed. Work to endorse this practice will continue throughout the year. Please click here for more information.
Medicinal Product Updates:
- Emcitate (tiratricol) has been recommended by the Committee for Medicinal Products for Human Use (CHMP) for marketing authorisation as the first treatment for MCT8 deficiency (Allan-Herndon-Dudley syndrome), a rare genetic disorder causing severe intellectual and motor disabilities due to impaired thyroid hormone transport.
- Keppra (levetiracetam) – dosing syringe updates for the solution formulation, with a 5mL syringe replacing the 3mL version for children with epilepsy aged 6 months to 4 years; caregivers should be advised on proper dosing and usage.
The EMA authorises medicines in the EU via the centralised procedure, granting EU-wide access after European Commission approval, or through national authorisation procedures like mutual recognition or decentralised processes, ensuring safety, efficacy, and quality standards. Please click here for more information.”
