The Management Board of the European Medicines Agency (EMA) met on 14 and 15 December in Amsterdam. It adopted the Agency’s multiannual programming document for the period 2023-2025, which includes the EMA’s work programme for 2023 and its budget for 2023. The Agency has announced a budget increase of 8.6% compared to 2022 (€458 million). A preliminary programming document for 2024-2026 was also adopted.
After the Covid-19 phase, the EMA plans to lift the business continuity measures put in place since 2020 in the context of the pandemic. Depending on the capacity available, the Agency will restart activities that were suspended or reduced in this framework.
In addition, from 31 January 2023, the Clinical Trials Information System (CTIS) will become the single-entry point for sponsors and regulators for the submission and assessment of all new clinical trials. The EMA Management Board was informed of the CTIS 2023 work plan and also agreed to review the current rules on disclosure of certain clinical trial documents and a review of the CTIS transparency measures for 2023.
The Board discussed the implementation report on the Veterinary Medicinal Products Regulation (EU/2019/6) and the pharmacovigilance elements. It welcomed commitments for improvements in the year 2023.
The Chair of EMA’s Committee for Advanced Therapies (CAT) presented key highlights and achievements of the Committee from 2017-2022 to the Board.
Finally, the Board adopted the Audit Strategy 2023-2025 and the Audit Plan 2023.
The audit strategy includes three objectives to be achieved between 2023 and 2025: - adding value to the achievement of the EMA’s mission and objectives in a sustainable way; - establishing and maintaining strong collaborations with internal and external stakeholders; - building new capabilities and embedding novel approaches into EMA’s operations.
According to the 2023 audit plan, the EMA announces that it will be subject to 14 audits next year. (Original version in French by Émilie Vanderhulst)