EMA Management Board: highlights of December 2023 meeting

Work programme and budget for 2024

The Board adopted EMA’s work programme for 2024, acknowledging that the Agency will continue to deliver on all its strategic priorities.

EMA and the Heads of Medicines Agencies (HMA) plan to review and update the European Medicines Agencies Network Strategy looking ahead to 2028, considering the implementation of EMA’s regulatory science strategy and the network strategy to 2025.

The 2024 budget increased by 4.5% compared to 2023, to a total of 478 million euros.

The final programming document for 2024-2026 will be published on EMA’s website towards the end of January 2024. The Board also adopted a preliminary programming document for 2025-2027.

Update on shortages of medicines

The Board acknowledged the progress made throughout 2023 to strengthen the existing framework for managing shortages of medicines in the European Union (EU). A range of tools and measures are now available, including a procedure for the solidarity mechanism, which allows Member States to support each other in the face of a critical medicine shortage, the EMA Medicines Shortages Steering Group (MSSG) Toolkit for tackling shortages of medicines, as well as the recommendations for actions to avoid shortages of key antibiotics used to treat respiratory infections during the winter season 2023/24. The first version of the Union list of critical medicines, published this week, was also welcomed by the Board.

Report from the chair of EMA’s safety committee (PRAC)

The chair of EMA’s safety committee, Dr Sabine Straus, gave an overview of the PRAC’s recent activities. The PRAC is the committee responsible for assessing and monitoring the safety of human medicines. In her presentation, Dr Straus shared her thoughts on how artificial intelligence (AI) will change the practice of pharmacovigilance, for example through real-time adverse event detection and more efficient data processing. Dr Straus also highlighted the key role that real-world evidence and patient engagement play in the work of the PRAC.

“The voice of the patient is critical during the whole life cycle of a medicine,” said Dr Straus. “The PRAC is looking to expand the use of real-world evidence, patient-reported outcomes and patient preferences for safety monitoring. The combination of various data sources and expertise will result in safer and more effective medicines for everyone.”

The Board acknowledged the work of the PRAC during the pandemic and its critical contribution to support the safety of medicines.

Veterinary Medicines Regulation

The Board welcomed the progress on the implementation of the Veterinary Medicines Regulation. In addition to many other activities, 35 guidance documents have now been drafted or updated to meet new legislative requirements, including three guidelines on data requirements for veterinary medicines for limited markets. The Union Product Database (UPD) data quality framework, which was launched in 2023, helps national competent authorities to identify opportunities for improving the information provided in the UPD. In addition, the public portal of the UPD, the Veterinary Medicines information website, was further improved in 2023 to make it easier for veterinary healthcare professionals and the public to use.

Clinical trials in the EU

The Board was updated on the progress of the Accelerating Clinical Trials in the EU (ACT EU) initiative and the operation of the Clinical Trials Information System (CTIS).

The ACT EU 2023-2026 workplan was published in November 2023 outlining the deliverables for the next four years, which aim to generate positive change in EU clinical research. Upcoming activities include a clinical trials analytics workshop in late January 2024 and the establishment of the multi-stakeholder platform advisory group.

Since 31 January 2023, the use of CTIS is mandatory for submission of initial clinical trial applications, with the number of submissions steadily increasing: from 100 new initial clinical trials in February 2023 to over 190 in October 2023. By 30 January 2025, ongoing trials approved before 31 January 2022, when the Clinical Trial Regulation became applicable, will need to be moved to CTIS. EMA and national authorities are preparing support programmes and communication campaigns to ensure that sponsors adhere to their responsibilities and promptly move information about all ongoing clinical trials to CTIS.

The Board noted the CTIS planning for 2024, which continues to focus on improving the performance of the system and enhancing user experience. A task force will be established to simplify business rules and a new public portal will be launched to ensure high levels of transparency, in accordance with the revised CTIS transparency rules.

Update from EMA’s Quality Innovation Group

The Board heard an update from the Quality Innovation Group (QIG) on its achievements in 2023 and plans for 2024. The QIG supports the translation of innovative approaches to the design, manufacture and quality control of medicines to deliver better quality of medicines and help support the resilience of supply chains and medicines availability. Key highlights from 2023 include two listen-and-learn focus groups with participation from industry, academia and international partners to discuss, amongst other topics, digitalisation and AI. The group also provided guidance and product-specific support. Looking to 2024, the QIG expects to continue its activities, share its learnings with the network and work closely with international partners on topics of mutual interest.

AI workplan

The Board endorsed the EMA / HMA Big Data Steering Group’s workplan on AI. The AI vision of the network is to create a medicines regulatory system that uses AI for personal productivity, automating processes and systems, increasing insights into data, and supporting more robust decision-making for the benefit of public and animal health. The AI workplan will be published on the EMA website shortly.