EMA sets out process to appoint next Executive Director
EMA’s September Management Board meeting advanced the process for appointing its next Executive Director while reviewing preparations for new EU pharmaceutical legislation
The European Medicines Agency has set out the procedure for choosing its next Executive Director, as its Management Board reviewed preparations for major changes to EU pharmaceutical legislation and the Biotech Act.
The process for appointing the next European Medicines Agency (EMA) Executive Director advanced at its September 2026 Management Board meeting, with members briefed on arrangements to nominate and appoint a successor to Emer Cooke.
The European Commission will first submit a shortlist of candidates, after which EMA will convene an extraordinary Management Board meeting to proceed with the nomination. EMA said it would publish a document setting out the arrangements shortly.
The succession comes as the regulator prepares to implement extensive legislative changes while taking on additional responsibilities.
Cooke, who has led EMA since 2020 and through the COVID pandemic, highlighted the growing workload while speaking to reporters on arrival in Dublin for the informal meeting of EU health ministers.
“We’re in full implementation mode at the moment,” Cooke said. “Most of our work at the moment is focusing on implementing the new pharmaceutical legislation, which streamlines a lot of our processes, helps us bring digitalisation [and] more streamlined methods.”
The management board noted that preparations for the EU’s new pharmaceutical legislation are well underway, with EMA working alongside the European Commission and European Medicines Regulatory Network.
Priority is being given to provisions expected to apply early, including transferable exclusivity vouchers for priority antibiotics, regulatory sandbox measures and the rules for avoiding medicine shortages.
The agency is also preparing for the Critical Medicines Act and measures to strengthen the availability and supply of critical medicines, as well as the Clinical Trials Information System (CTIS) and changes that could be required under the proposed EU Biotech Act.
Since its 2022 launch, CTIS has supported more than 14,000 clinical trials in Europe and receives more than 200 new trial applications each month.
According to information presented to the Board, proposed Biotech Act reforms affect around 70% of current CTIS functionality. Changes include faster trial assessments, greater flexibility for modifying ongoing trials, stronger cooperation between member states and more risk-based authorisation procedures.
The Board stressed the need to prepare ahead of adoption. Investment will be required in the existing CTIS, with work on a new platform incorporating the Biotech Act changes due to begin in early 2027. EMA will present a detailed roadmap to the Board in December.
“The Irish Presidency is working really hard on the Biotech Act,” Cooke said. “That’s all about faster clinical trials. That means more innovation, [getting medicines] faster to patients.”
With the proposal under discussion in the Council and European Parliament, the first changes to clinical trials rules could take effect in early 2028.
While there were some concerns that Donald Trump's “most-favored nation” policy would deter applications for market authorisations, EMA received 29 applications for new human medicines between January and June, maintaining 2025's high level. Requests for scientific advice for medicines have also increased, indicating sustained developer interest.