EMA’s Management Board met on 5 October in Amsterdam.

Clinical trials in the EU

The Board adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS). The revision focuses on the early publication of clinical trial data and documents that are most relevant for the public, including patients and the researcher community. More details about the revised transparency rules are available in a news announcement published on EMA’s corporate website.

Support for the implementation of the Clinical Trials Regulation (CTR) remains a priority. EMA presented the operational experience and recent improvements implemented in CTIS. The monthly number of submissions of clinical trials through CTIS continues to increase. By the end of August 2023, over 2000 initial applications have been submitted through CTIS, since launch of the system at the end of January 2022. The Board welcomed EMA’s continued efforts to support stakeholders via workshops, trainings and regular communications.

The EMA, European Commission and Head of Medicines Agency-led Accelerating Clinical Trials in the EU (ACT EU) initiative seeks to transform how clinical trials are initiated, designed and run in Europe. The Board welcomed the agreed model for the ACT EU multi-stakeholder platform to ensure that the initiative is driven by the views of stakeholders. EMA recently launched a dedicated ACT EU website to facilitate dissemination of information about the initiative: https://accelerating-clinical-trials.europa.eu/ 

Mid-year report 2023 

EMA presented the report of results and achievements of the Agency for the first half of 2023 to the Board.

Compared to the mid-year figures in the previous year, many areas have seen comparable developments. It was noted, however, that scientific advice and protocol assistance requests were 26% lower than in the same period last year. The Agency will monitor this development to identify whether this is a trend or a normal fluctuation as applications are typically not spread out evenly over the year. In previous years the Agency had also received a significant number of COVID-19-related scientific advice requests, a trend which is no longer expected. The mid-year report also shows increases in several areas of the business. The number of applications for similar biological products, for example, more than doubled: by mid-2023, nine applications were submitted vs four in 2022.

The number of initial evaluation applications for veterinary medicines also increased, from nine applications in 2022 to 15 in 2023. Requests for classification as veterinary limited market remained stable in the first six months of the year with a total of nine  requests.

The 2023 mid-year report will be published on the EMA website shortly.

EMA HR Strategy

The Board endorsed a new human resources (HR) strategy for the Agency. The HR strategy builds on work carried out over the recent years and details further priority actions for implementation between 2023 and 2025 aimed at attracting, managing and developing the best talent while creating a sustainable organisation that meets the current and future needs of the agency and its staff.


The Board welcomed the approval of two adapted COVID-19 mRNA vaccines targeting the currently circulating strains of SARS-CoV-2 to support autumn and winter vaccination campaigns in the European Union.

Share this page