EMA Management Board Advances New EU Pharmaceutical Legislation and Records 30 Veterinary Approvals in 2025

EMA's June 2026 Management Board meeting signals a regulatory environment in active transition, with manufacturers and QA leads facing converging timelines across new pharmaceutical legislation, clinical trial system changes, and expanded international cooperation frameworks.

The Board confirmed that preparations for implementing the new EU pharmaceutical legislation (NPL) are advancing across multiple delivery streams, aligned with the European Commission's work on delegated and implementing acts. An NPL Oversight Group has endorsed a network collaboration model drawing on expert involvement from across the European medicines regulatory network. For regulatory affairs leads building submission strategies into 2027, the pace of delegated act development will be the critical variable to track.

EMA's 2025 performance data, positively assessed by the Board, shows 104 positive recommendations for new human medicines under the centralised procedure, including 38 containing a new active substance. The Agency issued 30 recommendations for new veterinary medicines, the highest figure for a second consecutive year, with 13 involving a new active substance. The annual activity report will be published on the EMA website shortly, complementing the 2025 annual report released on 11 June.

On clinical trials, more than 14,000 applications have been submitted under the Clinical Trials Regulation (CTR) since the system went live in early 2022. The European Commission's December 2025 Biotech Act proposal introduces significant changes to the CTR and, by extension, to the Clinical Trials Information System (CTIS) managed by EMA. The Board noted the resource implications of those changes, a signal that sponsors and site teams should anticipate system and procedural updates within the CTIS workflow.

EMA's Emergency Task Force is also engaged with the newly created African Medicines Agency in response to the Bundibugyo virus Ebola outbreak in the Democratic Republic of Congo and Uganda, marking the first public health emergency in which EMA's ETF has coordinated with the AMA on clinical trial design and medical countermeasures. A three-way memorandum of understanding between the AMA, DG SANTE, and EMA is nearing completion, and a joint training programme for Francophone regulators is scheduled for October 2026.

The delegated and implementing acts underpinning the NPL remain the near-term milestone against which manufacturers should calibrate their regulatory readiness planning.

Source: European Medicines Agency via ema.europa.eu, 15 June 2026.