EMA Management Board: highlights of June 2026 meeting
EMA’s support to EU Ebola outbreak response; positive assessment of 2025 annual activity report
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Crisis preparedness and response
The Management Board welcomed EMA’s support to African regulators in the context of the Ebola outbreak in the Democratic Republic of Congo and Uganda caused by the Bundibugyo virus.
This is the first public health emergency where EMA’s Emergency Task Force (ETF) is engaging with the newly created African Medicines Agency (AMA) alongside participating African national regulatory authorities in its discussions with developers on possible clinical trial designs and medical countermeasures.
This engagement, grounded in the ongoing scientific collaboration between EMA and the AMA, is intended to support efficient, coordinated and timely regulatory responses to the outbreak. It also builds on the extensive experience gained through collaboration with African regulators during previous Ebola outbreaks, as well as the ongoing operationalisation of the AMA. The news announcement is available.
Positive assessment of EMA’s activities in 2025
The Board positively assessed the Executive Director’s 2025 annual activity report, which describes the implementation of the Agency’s work programme and the management and control systems in place.
The Board noted the work on marketing authorisations via the centralised procedure, both in human and veterinary medicines. EMA delivered 104 positive recommendations for new medicines for human use, including 38 containing a new active substance, many of them addressing unmet medical needs. The Agency issued 30 recommendations for new veterinary medicines - the highest number of recommendations for a second consecutive year. Of these, 13 had a new active substance.
The Board also acknowledged activities carried out to accelerate and optimise assessment processes, as well as the Agency’s continued role in addressing challenges related to the availability of medicines and security of supply.
The annual activity report will be published on the EMA website shortly. This complements EMA’s 2025 annual report that was published on 11 June.
Preparations for implementation of the new EU pharmaceutical legislation
Preparations for implementing the new EU pharmaceutical legislation (NPL) have progressed. The Board received a comprehensive overview of the activities under the NPL EMA Management Board governance structure. Planning is advancing across the delivery streams, aligned with the European Commission’s work on the delegated and implementing acts. The NPL Oversight Group has also endorsed a network collaboration model to ensure broad expert involvement from across the European medicines regulatory network in the preparations from the outset.
Update on collaboration with the African Medicines Agency (AMA)
As highlighted above regarding the Ebola outbreak, EMA and EU national authorities continue to support the operationalisation of the AMA, as well as technical training and exchanges at national and regional levels. Future activities include a joint training programme for Francophone regulators in October 2026, jointly organised by the AMA and EMA, as well as plans to launch new grants for national regulatory capacity building. A three-way memorandum of understanding between the AMA, DG SANTE and EMA to formalise cooperation and further strengthen cooperation in medicines regulation is also nearing completion.
Watch the video featuring Emer Cooke, EMA's Executive Director, and Delese Mimi Darko, Director-General of the AMA, sharing insights into their partnership.
Clinical trials in the EU
The Board was updated on progress with clinical trials in the EU. Between ‘go live’ in early 2022 and the end of May 2026, more than 14,000 clinical trial applications have been submitted under the Clinical Trials Regulation (CTR). In December 2025, the European Commission adopted its proposal for the Biotech Act, which foresees significant changes to the CTR, and consequently to the Clinical Trials Information System (CTIS) managed by the Agency. The Board noted the need to allocate resources to prepare for these changes to be ready as soon as possible and before the legislative process has been concluded.
The Board noted progress on the EU’s new clinical trial targets and was updated on recent initiatives aimed at strengthening clinical trials under the ACT EU programme as well as other network initiatives, for example, FAST EU, a pilot led by the Heads of Medicines Agencies (HMA).
Update from Network Data Steering Group
EMA, in collaboration with the national medicines agencies, is further developing the product management service (PMS) to support regulatory activities across the EU with structured and standardised medicinal product master data for all human medicines authorised in the EU. These data are routinely used by regulators and industry, e.g. pharmacovigilance and shortages activities, and other targeted regulatory procedures.
The Agency is now looking at enabling wider use beyond medicines development and regulation by the public. From 12 June 2026, PMS will make additional data publicly accessible through the release of a ‘beta’ version of an Application Programming Interface (API) for public use. PMS data are already available via a web interface, but the API will enable external access in a structured, machine-readable format. This is an important step towards greater transparency, improved accessibility and broader use of trusted EU medicinal product information. With the beta release, EMA and stakeholders can gain experience, test use cases and further refine the service. Release of a final API version is planned for early 2027.