Amsterdam: The European Medicines Agency (EMA) told its Management Board on 10-11 June 2026 that its Emergency Task Force is working with the new African Medicines Agency (AMA) and African national regulators to speed vaccines and treatments against an Ebola outbreak in the Democratic Republic of the Congo and Uganda, the first public-health emergency the two agencies have tackled together. The board, whose highlights were published on 15 June, welcomed the EMA Ebola response as a test of cross-continental regulatory cooperation.
An EMA Ebola response built on new partnerships
The outbreak is caused by the Bundibugyo virus, which the World Health Organization declared a Public Health Emergency of International Concern on 17 May 2026. Unlike the more common Zaire ebolavirus, Bundibugyo has no authorised vaccine or treatment, so existing countermeasures must be adapted and tested quickly.
Through horizon scanning and contact with developers and the WHO, EMA’s Emergency Task Force has flagged candidates now being discussed for clinical trials:
- Three vaccine candidates, including an rVSV-based vaccine, a ChAdOx1 adenovirus-platform vaccine and an mRNA vaccine.
- Three treatment candidates: the antibody combination MBP-134, the antiviral remdesivir and the monoclonal antibody maftivimab.
- One post-exposure option, the antiviral obeldesivir.
The European Centre for Disease Prevention and Control assesses the risk to people in the EU and EEA as very low.
What the WHO says
This outbreak is caused by the Bundibugyo virus, for which no licensed vaccine or treatment currently exists. But this is not without hope. — Tedros Adhanom Ghebreyesus, WHO Director-General, 30 May 2026.
The WHO declared the outbreak a Public Health Emergency of International Concern and has urged that promising candidates move quickly into well-designed trials. More detail is set out in the WHO expert advice on Ebola candidates.
A strong year for new medicines
The board also signed off on the agency’s 2025 results. EMA delivered 104 positive recommendations for new human medicines, including 38 with a new active substance, and 30 recommendations for new veterinary medicines, the highest annual tally for a second year running.
Preparing the new pharmaceutical rules
Work to implement the reform of the EU’s pharmaceutical legislation is advancing in step with the Commission’s delegated and implementing acts. The board noted that more than 14,000 clinical-trial applications have been filed under the Clinical Trials Regulation since early 2022, and that the agency must prepare its systems for changes flagged in the Commission’s December 2025 Biotech Act proposal.
Opening up medicines data
From 12 June 2026, EMA’s Product Management Service began releasing a public beta of an Application Programming Interface, giving researchers and the public machine-readable access to trusted master data on authorised EU medicines. A final version is planned for early 2027.
Background
The African Medicines Agency is a young continental regulator, and the Ebola collaboration marks the first emergency since it became operational. EMA has supported African regulators through previous Ebola outbreaks via the WHO-AFRO African Vaccines Regulatory Forum, and a memorandum of understanding between the AMA, the Commission’s health department and EMA is near completion. A joint training programme for Francophone regulators is planned for October 2026.




