EMA Management Board: highlights of December 2022 meeting

At its meeting of 14-15 December 2022 in Amsterdam, the European Medicines Agency (EMA) Management Board heard an update on the recent activities related to the response to COVID-19. Since the start of the pandemic, a total of seven vaccines, four adapted booster vaccines and eight treatments have been authorised for use in the European Union (EU).

EMA multiannual programming and 2023 budget

The Board adopted EMA’s multiannual programming document for 2023-2025, including the Agency’s work programme and budget for 2023. The document will be published on EMA’s website in the first quarter of 2023. The 2023 budget increased by 8.6% compared to 2022, to a total of 458 million euros. The Board also adopted a preliminary programming document for 2024-2026.

EMA’s work programme for 2023 foresees the gradual lifting of business continuity measures that were implemented in the course of the Agency’s relocation and had to be maintained since 2020 to cope with the COVID-19 pandemic and the initial waves of infection. By monitoring the evolution of the workload related to COVID-19 and based on resource availability, the Agency will seek opportunities to gradually reinitiate previously suspended or reduced activities, notably implementing a phased restart of clinical data publication (CDP) for centrally authorised medicines beyond the scope of COVID-19. The Board noted that, in case of significant changes to the business continuity status, the programming document will be amended accordingly.

Implementation of the Clinical Trials Regulation

On 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 system was launched on 31 January 2022, starting the clock for the one-year transition time for all sponsors of clinical trials. During the transition period clinical trial sponsors can still choose whether to submit an initial clinical trial application in line with the Clinical Trials Directive or under the Clinical Trials Regulation, via CTIS. On 31 January 2023, the use of CTIS will become mandatory for new clinical trial applications.

The Agency informed the Board that the system delivers the functionality required for new clinical trial applications which will continue to be developed and enhanced. The Board noted the progress towards further stabilisation of the system in preparation of compulsory use. This stabilisation will improve user experience. The Agency informed the Board about its delivery plan to ensure no blocking technical issues in the core processes by the legal deadline and its commitment to this plan.

The Board welcomed the 2023 CTIS workplan which focusses on enhancing the user experience by implementing improvements in the most impactful functional areas of the system, future proofing and minimising risks to the technical core of CTIS. The Board also agreed to review the current rules on disclosure of certain clinical trial documents and a review of CTIS transparency measures for 2023. As the initiation of this workplan is subject to the stabilisation of the system, the Agency committed to update the Board on a weekly basis on the progress towards stabilisation and full functionality of the system. This update will start on Friday 16 December and stakeholders will be kept regularly informed. 

The Agency informed the Board of the various potential risk scenarios and of the development of a business contingency plan.

Implementation of the Veterinary Medicinal Products Regulation

The Board noted the last regular report on the implementation of the Veterinary Medicinal Products Regulation since its coming into application in January 2022. The programme delivered the Union Product Database (UPD), an upgraded system for pharmacovigilance reporting and management of safety signals, as well as changes to a total of nine IT systems over the course of the last four years. The Board noted the efforts and collaboration between Member States and EMA to complete the data upload into the UPD and plans to focus on enriching these data over the next year. The Board welcomed the commitment to improve the systems in 2023 following the Agency’s agile governance model, as well as the plan of the Veterinary Division to work on the implementation of the EU Veterinary Big Data strategy over the next five years.

Committee for Advanced Therapies Report

The Chair of EMA’s Committee for Advanced Therapies (CAT) presented key highlights and achievements of the Committee from 2017-2022 to the Board. The CAT is responsible for assessing the quality, safety and efficacy of advanced therapy medicinal products (ATMPs). The Committee prepares a draft opinion on each ATMP application submitted to the Agency before the Committee for Medicinal Products for Human Use (CHMP) adopts a final opinion on the marketing authorisation of the medicine concerned.

Since 2017, the work of the Committee has led to the authorisation of 17 ATMPs, the majority being gene therapy medicinal products. These include six chimeric antigen receptor (CAR) T-cell medicines and gene therapies to treat orphan diseases such as spinal muscular atrophy and severe haemophilia A and haemophilia B in the EU. In 2020, the CAT advised against the use of unregulated cell-based therapies in response to the promotion of unproven cell-based therapies as cures for a broad range of conditions including for example cancer, cardiovascular diseases and autism by individuals, companies and hospitals.

The Board acknowledged the work of the Committee in the last six years and its continued efforts to support ATMP developers through the production of guidance documents and the organisation of workshops and training.

Audit strategy 2023-2025 and audit plan 2023

The board adopted the audit strategy 2023-2025 and the audit plan 2023. These documents outline the audit activities proposed to be undertaken at EMA in 2023 and the rolling audit plan related to 2024-2025. The audit strategy includes three objectives to be fulfilled between 2023 and 2025: sustainably adding value to the achievement of EMA’s mission and objectives; establishing and maintaining strong and fruitful collaborations with internal and external stakeholders; building new capabilities and embedding novel approaches into the agency’s operations. The Board welcomed EMA’s guiding principle of transparency and accountability and was informed that, in 2023, the Agency is foreseen to be subject to 14 audits.