CHAPTER 1: KEY ACHIEVEMENTS IN 2025
Enhancing the sustainability of the network
The European medicines regulatory network is the backbone of medicines regulation in Europe, connecting NCAs, EMA and expert bodies in a collaborative system that protects public health across the continent. The sustainability of the network remains a key priority as EMA navigates an increasingly complex regulatory landscape. In 2025, EMA made significant progress in strengthening the network's resilience through targeted initiatives focused on simplification of processes, capacity building through training and enhanced collaboration.
EU Medicines Agencies Network Strategy (EMANS) to 2028
A cornerstone achievement of 2025 was the publication of the EU Medicines Agencies Network Strategy (EMANS) to 2028, following its adoption by HMA and the EMA Management Board. The strategy, titled ‘Seizing opportunities in a changing medicines landscape’, is a comprehensive update of the five-year strategy, which was developed in consultation with stakeholders to cover the period 2021 to 2025 (EMANS 2025) . It will guide the network over the next few years to meet the challenges ahead, including preparing for, and responding to, public health emergencies and threats such as antimicrobial resistance. The final report of EMANS 2025 will be published in March 2026.
The six focus areas of the strategy to 2028 build upon those in the EMANS to 2025, with the updated strategy placing more emphasis on the competitiveness of the EU in the development and manufacture of medicines, as well as the use of AI throughout the medicines lifecycle.
Focus areas for EMANS 2028
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Accessibility
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Leveraging data, digitalisationand artificial intelligence
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Regulatory science, innovation and competitiveness
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Antimicrobial resistance and other health threats
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Availability and supply
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Sustainability of the network
With the strategy to 2028, our aim is to ensure a transparent, forward-looking and science-driven roadmap to managing the network's public health priorities. In the face of a new global framework, it is important that the European medicines regulatory agencies contribute to EU competitiveness. We are committed to catalysing the innovation of medicines and their manufacture by leveraging every opportunity to promote public and animal health.
Maria Lamas, Chair of the HMA Management Group
A key focus area of the strategy is the sustainability of the network - to ensure that it has available resources to support its scientific and regulatory decision-making, taking full advantage of technological advances. The strategy also highlights the need for simplicity in regulatory processes, recognising that administrative complexity drains valuable scientific resources which are better directed toward evaluating the safety and efficacy of medicines.
In these uncertain times, when our environment is evolving constantly, we need to be agile and able to anticipate transformative changes, as well as to better address supply chain security. This update to our network strategy enables us to seize opportunities across the entire medicines lifecycle – from innovation through to availability and access in the EU.
Emer Cooke, EMA’s Executive Director
The EMANS to 2028 and its implementation were presented during EMA’s 30th anniversary scientific conference in May: EMA’s 30th anniversary scientific conference - medicines, regulation and the future .
Implementation of the EMANS has already yielded tangible benefits, including improvements in the assessment procedure and strengthening of work-sharing arrangements, which have resulted in additional capacity being freed up for assessment teams. Through streamlined templates for common regulatory procedures, EMA has reduced duplication of effort and enabled rapporteurs and co-rapporteurs to focus on substantive scientific assessment rather than administrative formatting. Work-sharing arrangements have been strengthened, allowing centres of excellence within the network to lead on specific therapeutic areas or regulatory challenges, ensuring that appropriate expertise is applied to each evaluation while building capacity in participating authorities.
Capacity building through training
The sustainability of the network requires continuous investment in people and skills. In 2025, EMA continued to deliver coordinated training programmes through the EU Network Training Centre (EU NTC) to build regulatory expertise across Member States.
In 2025, EMA expanded its training programme in the area of Good Clinical Practice (GCP) inspections through targeted training initiatives for GCP inspectors. These included a specialised training day for GCP inspectors on ICH E6 (R3) implementation in June 2025 following the ACT EU workshop on ICH E6 (R3) (principles and Annex 1) in February 2025. In addition, in May 2025, the first online training course on GCP inspections for assessors of marketing authorisation applications submitted to the Agency was published.
These initiatives contributed to a significant increase in GCP inspections requested in 2025 (see section 3.1.2 GCP inspections) and have equipped GCP inspectors and assessors across the network with enhanced competencies in evaluating and inspecting clinical trials, ensuring the network can meet growing demands while maintaining the highest standards of scientific rigour.
EMA also pioneered innovative training methods. In October 2025, EMA hosted a data-integrity session for good manufacturing practice (GMP) inspectors, in collaboration with the EU4Health (EU4H) consortium. This was the first time the Agency offered a training session that incorporated virtual reality. The session was attended by inspectors from the EU network and, reflecting EMA’s efforts to strengthen regulatory systems in Africa and supporting the establishment of the African Medicines Agency (AMA), 20 participants from five different African Regional Economic Communities.
Assessors’ day @ EMA
In November 2025, EMA hosted an Assessors’ Day, organised by the EU NTC. This event brought together assessors from four key scientific disciplines — clinical, non-clinical, quality and pharmacovigilance — and from across the EU/EEA NCAs. The event offered EU assessors a unique opportunity to connect, network, and share knowledge and experiences face-to-face, developing a stronger sense of community and enhancing collaboration across the EU medicines regulatory network. The key theme was the benefit-risk evaluation of medicines, with sessions dedicated to the critical scientific and regulatory aspects that shape these decisions. Additionally, a session on communication explored how assessors can effectively convey their scientific work to different audiences.
Reinforcing network crisis preparedness through a major event simulation exercise
In December 2025, EMA coordinated a major event simulation exercise together with partners from the European medicines regulatory network (EMRN) and the European Commission, to test the EMRN incident management plan for medicines for human use , as well as key processes in place to deal with major events which could have a serious impact on public health. The plan aims to prevent incidents from becoming major events and, where needed, to escalate them to EMA’s MSSG. It was revised in November 2025 to include lessons learned from previous incidents and the COVID-19 pandemic. The revised plan also reflects the changes brought by the regulation reinforcing EMA’s role (Regulation 2022/123).
The simulation focused on a fictitious human medicine safety incident with a root cause in quality. Based on the findings, EMA will consolidate relevant procedures and guidance. Key highlights of the exercise, including main findings and next steps, will be published in the coming months.