EMA Management Board highlights — September 2026

Mid‑year report 2026

EMA presented its operational results for Jan–Jun 2026: 29 applications for new human medicines were received, and seven initial veterinary marketing authorisation applications were filed (compared with 12 in H1 2025). Requests for scientific advice for both human and veterinary medicines have risen. The Agency said the 2026 mid‑year report will be published shortly.

Preparations for the new EU pharmaceutical legislation

EMA is advancing implementation of the new pharmaceutical legislation jointly with the Commission and the European Medicines Regulatory Network. Work has prioritised early entry measures such as transferable exclusivity vouchers for priority antibiotics, the regulatory sandbox and shortage management. Stakeholders will be kept informed via EMA communication channels and the NPL hub page.

Nomination of the next Executive Director

The Management Board reviewed procedural arrangements for nominating and appointing the next Executive Director. An extraordinary Board meeting will be convened once the European Commission submits a shortlist of candidates; the arrangements document has been published.

CTIS and the proposed Biotech Act

Since its 2022 launch CTIS has supported over 14,000 trials and receives more than 200 new applications monthly. Modernisation began in 2025 and EMA plans to deliver Biotech Act‑related functionality via a new CTIS platform, with work starting in early 2027 and a detailed roadmap, including resource impacts, due to the Board in December 2026. The Biotech Act proposal (Commission, Dec 2025) could see first regulatory changes enter into force as early as early 2028 and affects roughly 70% of current CTIS functionality.