EMA Management Board: highlights of June 2025 meeting

Management Board meets the African Medicines Agency Governing Board

The Management Board welcomed the African Medicines Agency (AMA) Governing Board and heads of African national agencies as observers in a first-of-its-kind meeting between the European and African regulatory network. The delegation was led by Dr Yossounon Chabi, Chair of the AMA Governing Board and Director-General of the Benin Agency for Medicines and Health Products, and included Dr Delese Mimi Darko, the newly elected AMA Director-General Designate and Chief Executive of the Ghana Food and Drugs Authority. Observing the meeting gave the delegation the opportunity to gain insights into the governance and supervisory role of the Management Board across a broad range of activities, including strategic, financial and operational matters. Representatives from the European Commission’s Directorate-General for International Partners (DG INTPA) and the World Health Organization (WHO) also participated.

The meeting is part of EMA and the European network’s commitment to supporting the AMA and strengthening of regulatory systems in Africa more broadly. Organised by EMA, the project is funded through the European Union (EU) Global Gateway Initiative.

Positive assessment of EMA activities in 2024

The Board positively assessed the Executive Director’s annual activity report for 2024. The report describes the implementation of the Agency’s work programme and the management and control systems in place.

The Board noted EMA’s continued work to address medicines shortages, highlighting the measures the Agency has taken to ensure the availability of medicines through the monitoring, management and prevention of critical shortages, carried out with Member States through the Medicine Shortages Single Point of Contact (SPOC) Working Party and the Medicine Shortages Steering Group (MSSG). In the area of antimicrobial resistance (AMR), the Board also noted that in 2024 EMA once again joined forces with the European Centre for Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA), publishing the fourth joint report on the analysis of the consumption of antimicrobial agents and occurrence of AMR in bacteria from humans and food-producing animals (JIACRA IV). This is part of EMA’s One Health approach.

The high number of medicines assessed for initial approval was positively noted by the Board, as were the Agency’s standard-setting practices for patient involvement and its increasing role as an enabler of global health.

The annual activity report will be published shortly.

Update from CHMP chair

Bruno Sepodes, chair of EMA’s human medicines committee (CHMP), presented an overview of recent achievements and challenges in the work of the CHMP.

“2025 is a year of great possibility, with innovative medicines and vaccines advancing through the pipeline,” said Professor Sepodes. “Our regulatory environment is evolving rapidly. The CHMP expects expanded responsibilities from the groundbreaking revision of the EU pharmaceutical legislation; at the same time, advances in science and technology are reshaping how we evaluate medicines, while digitalisation, automation and artificial intelligence will improve and streamline the way we work.”

Professor Sepodes reiterated the CHMP’s commitment to upholding the highest scientific standards of quality, safety and efficacy of medicines for patients in the EU, while promoting the use of emerging technologies and methodologies to enhance EU competitiveness. He also highlighted the ongoing concerns regarding quality and timeliness of some marketing authorisation applications which can impact regulatory efficiency. The CHMP is actively supporting EMA and the European medicines regulatory network’s ongoing initiatives to improve efficiency in the assessment and approval processes for new medicines in the EU.

Election of new vice-chair

The Board elected Aimad Torqui as its new vice-chair, with a three-year mandate from September 2025. Mr Torqui currently serves as Division Head and Deputy Director at the Medicines Evaluation Board (MEB) in the Netherlands and is a member of the MEB executive management team. In this capacity, he is responsible for national and European efforts in regulatory policy and regulatory science. He oversees the coordination of MEB’s participation in EMA scientific committees and working parties and holds responsibility for policies aimed at improving the better use of medicines. He also oversees MEB’s veterinary medicinal products unit, which is responsible for assessing and approving veterinary products. Mr Torqui has been the Netherlands’ alternate member on the EMA Management Board since October 2022 and a full member of the Board since April 2025.

Progress with clinical trials in the EU

The Board was updated on progress with clinical trials in the EU. Since its launch in 2022, the Clinical Trial Information System (CTIS) has received over 11,300 initial applications, with more than 9,300 authorised by EU Member States. Simplifying CTIS business rules remains a key priority, and a roadmap for modernising the system is currently under development.

The Accelerating Clinical Trials in the European Union (ACT EU) initiative continues to support the implementation of the Clinical Trials Regulation (CTR). Upcoming milestones include the finalisation of the redesign of CTIS/CTR training materials for trial sponsors and the planned publication of key performance indicators to assess the attractiveness of the EU for clinical research, as well as the speed and impact of clinical trials across the EU.

EMA code of conduct

The Board endorsed an update to EMA’s code of conduct, which sets out clear professional standards of integrity, impartiality and independence for everyone working at, or with, EMA, including staff members, Management Board members and scientific committee experts. The code consolidates existing legal provisions, rules and policies into a single, accessible document. It references the new rules on handling competing interests that were adopted by the Board in 2024. The document also draws attention to the whistleblowing protections for EMA staff, and the clear standards for public engagement, reflecting EMA’s dedication to transparency and accountability.

The updated code of conduct will be published shortly.