EMA Management Board: highlights of October 2024 meeting

4 October 2024

Board elects new vice-chair and endorses draft network strategy to 2028 for public consultation

Election of new vice-chair

The Management Board elected Rui Santos Ivo, President of the Portuguese National Authority of Medicines and Healthcare Products (INFARMED), as its new vice-chair, with a three-year mandate from October 2024. Professor Ivo is an Associate Professor of Medicines Regulation at the University of Lisbon Faculty of Pharmacy and holds a post graduate degree in Health Management, Health Law and Pharmaceutical Legislation from the University of Lisbon. He has held positions at EMA and the European Commission and was chair of the Heads of Medicines Agencies (HMA) Management Group from 2004 to 2005. He has been a member of the EMA Management Board since 2016.

European medicines agencies network strategy to 2028

The Board endorsed the updated European medicines agencies network strategy (EMANS) to 2028 for public consultation. This is a review and extension of the original five-year strategy, which was developed to cover the period 2021 to 2025 (EMANS 2025). Extending the timeframe to 2028, the update has been initiated now to take into account progress made to date and the technological advances, environmental challenges and other developments that are reshaping the regulatory landscape. This includes preparing the network for the implementation of the revised European Union (EU) pharmaceutical legislation when finalised. A separate news announcement will be published at the start of the two-month consultation next week.

Handling declarations of interests of scientific committee members and experts

The Board endorsed a draft revision to EMA’s policy on handling of competing interests of scientific committees’ members and experts (Policy 0044) for public consultation. EMA’s independence policies have provided a robust and balanced framework for managing possible competing interests over many years. The revision aims to reflect changes to this framework following recent court judgements (i.e. the appellate judgments of the Court of Justice in Joined Cases C-6/21 and C-16/21 P and Case C-291/22 P).

A news announcement with additional information will be published at the start of the public consultation in the coming days, together with the draft revised policy. The final revised policy is intended to be presented to the Board for adoption in December 2024.

Mid-year report 2024

EMA presented results and achievements of its and the regulatory network’s operations for the first half of 2024 to the Board. Between January and June, applications for new medicines (orphan and non-orphan) have for the second year in a row seen an increase of 20% (30 vs 25 applications in Q1-Q2 2023). Furthermore, applications for biosimilar products have more than tripled (25 in Q1-Q2 2024 compared with 8 in the same period last year). The total number of scientific advice and protocol assistance requests increased by 16% compared to the first half of 2023, with 402 requests received in Q1/Q2 2024 (348 in the same period in 2023).

EMA joined forces with the European Centre for Disease Prevention and Control (ECDC), the European Chemicals Agency (ECHA), the European Environment Agency (EEA) and the European Food Safety Authority (EFSA) to launch a joint framework to strengthen cooperation on the implementation of the One Health agenda in the EU, recognising the connection between the health of people and animals, and the environment. The mid-year report also highlights preparations for the ongoing revision of the EU pharmaceutical legislation.

The 2024 mid-year report will be published on the EMA website shortly.

Mandate of the new Network Data Steering Group

The Board endorsed the mandate of the new Network Data Steering Group (NDSG), a strategic advisory group set up to oversee data strategy and governance in the European medicines regulatory network. The group’s mandate will combine the scope of the current HMA-EMA Big Data Steering Group (BDSG) and the Network Data Board (NDB) into one data governance body established to maximise data interoperability, exchange and use across the network, access to data and generation of evidence, and the use of artificial intelligence.

The NDSG will also advise the HMA and the Management Board on the prioritisation, planning and monitoring of actions relevant to the EMANS to 2028, especially in the areas of leveraging data, digitalisation and AI. The group will be co-chaired by EMA and HMA. Its members will include representatives from national competent authorities, EMA and the European Commission, as well as representatives from stakeholder groups, including EU patient associations. The mandate of the group is published.

Clinical trials in the EU

EMA updated the Board on upcoming milestones for clinical trials in the EU. By 30 January 2025, all ongoing trials approved under the previous Clinical Trials Directive need to be transferred to the Clinical Trials Information System (CTIS) to adhere to the Clinical Trials Regulation. Around 3,000 clinical trials have already been transitioned to CTIS. Sponsors are strongly advised to submit the remaining applications as soon as possible considering the time necessary to complete the authorisation process, which can take up to three months.

With the implementation of the revised transparency rules, information and documents on over 6,100 trials are now available on CTIS. New features introduced in September allow users to search for specific trials more easily. In addition, changes have been made to the interface to improve the overall user experience. The Accelerating Clinical Trials in the EU (ACT EU) initiative is holding the annual meeting of its multi-stakeholder platform on 22 October 2024. The event will be broadcast and is open to all relevant stakeholders.

International activities

The Board was updated on international activities at EMA, including on the EC / EMA / European Food Safety Authority bilateral meeting with the United States Food and Drug Administration in April, which presented an opportunity to review ongoing initiatives, discuss strategic priorities and further strengthen continuous close collaboration. The Board was also updated on the Agency’s efforts to strengthen and expand global reliance in medicine regulation. Successful initiatives include the ‘Opening Procedures at EMA to Non-EU authorities’ (OPEN) framework, EMA’s leadership role in the International Coalition of Medicines Regulatory Authorities (ICMRA) and its role in the context of the global response to the mpox outbreak in the Democratic Republic of the Congo (DRC) and other countries. Other updates covered support for the African Medicines Agency and engagement with EU candidate countries and potential candidates including observer participation in selected working groups, training and twinning opportunities.