Here is our regular summary of content of relevance to neurology from the Human Medicines Highlights – October 2026
The ACT EU pilot becomes permanent!
The ACT EU advice pilot, which helps prepare clinical trial applications, will become a permanent initiative from January 2027. The EAN has been represented within the group since its inception. Click here for more details: Clinical trial applications advice pilot becomes permanent | European Medicines Agency (EMA)
Other EMA News Updates:
- Women are missing from medicines development: EMA’s roadmap for change
A multistakeholder workshop identified 10 priority actions to improve how women’s health is addressed in medicines development and regulation. These will inform an EMA roadmap due by the end of 2026. Click here for more details: Women are missing from medicines development: EMA’s roadmap for change | European Medicines Agency (EMA)
- Executive Director speech at EMA women’s health multistakeholder workshop
Emer Cooke spoke about the EMA’s role in improving health outcomes for women at the workshop held on 28 September. Click here for more details: Executive Director speech at EMA women’s health multi-stakeholder workshop | European Medicines Agency (EMA)
- Global regulators call for advancing alternatives to animal testing across the medicine lifecycle
The EMA endorsed a joint statement by international regulators calling for continued progress in replacing animal testing throughout the medicines lifecycle. Click here for more details: Global regulators call for advancing alternatives to animal testing across the medicine lifecycle | European Medicines Agency (EMA)
- EMA Management Board: highlights of the September 2026 meeting
The Management Board discussed several topics, including the EMA’s mid-year report and implementation of the new pharmaceutical legislation. Click here for more details: https://ec.europa.eu/newsroom/ema/redirection/item/958981/en/3490
- Increasing transparency on patient experience data (PED) in regulatory assessments
The EMA’s assessment report for Imdylltra (tarlatamab) includes a dedicated section on patient experience data. Patient-reported outcomes were considered as part of the medicine’s efficacy evidence. Click here for more details: IMDYLLTRA, INN-tarlatamab
Medicines:
- Ocrevus (ocrelizumab) New risk of drug-induced liver injury - Hoffmann-La Roche Ltd and Genentech, in agreement with the EMA and national competent authorities, have issued a safety communication highlighting a new risk of drug-induced liver injury associated with ocrelizumab (Ocrevus), recommending liver function monitoring before and during treatment and discontinuation if liver injury is confirmed. Click here for more details: Ocrevus (ocrelizumab) New risk of drug-induced liver injury
