EMA mid-year report 2025
EMA presented results and achievements of its operations for the first half of 2025. Between January and June, applications for new medicines (orphan and non-orphan) remain at the same high level as last year (29 vs 30 applications in Q1-Q2 2024). In veterinary medicines, the Board noted the same high level of applications as in 2024 (12 vs 11 applications in Q1-Q2 2024) and anticipates an increase above the initial forecast for the whole of 2025.
The Board welcomed the positive trend in reduction of company clock stop extensions in Q1-Q2 2025 – an average of 150 days compared to an average of 182 days in 2024 (an approximately 18% reduction). This was achieved thanks to EMA’s initiative to reinforce best practices for requests for clock stop extensions from companies. The overall objective of the initiative is to accelerate access to safe and effective treatments by reducing delays in the approval process.
The 2025 mid-year report will be published on EMA’s website shortly.
International collaboration
The Board was updated on the activities of the International Coalition of Medicines Regulatory Authorities (ICMRA) which has been chaired by EMA since 2019. Over the past six years, EMA has spearheaded global efforts to strengthen regulatory cooperation and ensure alignment on regulatory issues, such as antimicrobial resistance, supply chain integrity and responding to public health crises.
Public awareness of the role of ICMRA and its work, especially during the COVID-19 pandemic, has grown significantly over the past six years. EMA will pass the baton to the next chair of the coalition who will be elected during the upcoming ICMRA summit to be held in Amsterdam from 21-24 October.
In addition, the Board agreed to expand the scope of EMA’s OPEN Framework to include all medicines that target unmet medical needs and advanced therapy medicines products (ATMPs). The Board also agreed to allow the use of the OPEN framework for post-authorisation changes, including extensions of indication. A questions-and-answers document on this expanded scope will be published towards the end of the year.
The OPEN initiative was originally endorsed by the Board in December 2020 to allow medicine regulators from outside the EU and the World Health Organization to take part in EMA’s scientific evaluation of COVID-19 vaccines and therapeutics.
First network data strategy
The Board endorsed the first data strategy for the European medicines regulatory network. The strategy sets out principles and goals to ensure the network’s data assets are managed optimally, are of high quality and standardised where appropriate, and are easy to share and use for regulatory decision making.
The strategy focuses on data shared between medicines agencies, such as regulatory submissions data, master data and healthcare data. It is a key deliverable of the Network Data Steering Group workplan 2025-2028 and supports the European Medicines Agencies Regulatory Network Strategy (EMANS) to 2028 goal of leveraging data, digitalisation and artificial intelligence.
Other updates
The Board was updated on work ongoing within the Heads of Medicines Agencies (HMA) / EMA Strategic Resource Oversight Group, focusing on capacity and capability building at national competent authority (NCA) level. While this work is ongoing, actions to expand the pool of experts supporting the work of the network were agreed, including the possibility to also engage experts from outside the EU / EEA. The success of these activities will be reviewed within a two-year period.
