Regulatory cooperation to improve global health

EMA's operating environment in 2024 was characterised by technological advances and evolving healthcare needs. Multiple challenges shaped the regulatory landscape, from public health threats, such as antimicrobial resistance and new variants of viral diseases such as COVID-19 and mpox, to the transformative potential of AI in medicines development and advance in medical innovations. These developments reinforced the critical importance of a collaborative approach to medicines regulation and global health, both at EU level and internationally.

Throughout the year, EMA intensified its efforts to address these challenges by building on its strong partnerships across the EMRN and with its global partners and stakeholders.

EMA at the heartof the EU network

The EMRN remains the cornerstone of EMA's work and success. Operating at the heart of this network, EMA coordinates and supports interactions between NCAs for human and veterinary medicines across Europe, ensuring a harmonised approach to medicines regulation.

Advancing the European medicines agencies network strategy to 2028

A significant milestone in 2024 was the publication of the draft joint EU medicines agencies network strategy to 2028 (EMANS 2028) by EMA and the HMA for a two-month public consultation. The strategy, 'Seizing opportunities in a changing medicines landscape', represents a comprehensive update to the original EMANS to 2025 framework, responding to changes in the regulatory and technological landscape, some more rapidly than anticipated.

The overarching theme of our updated strategy to 2028 is that of change – rapid, somewhat unpredictable but nonetheless full of promise. It will guide the network as it seizes opportunities and meets the challenges of the near future, including preparing for and responding to public health emergencies and threats such as antimicrobial resistance.

Emer Cooke, EMA's Executive Director

The EMANS 2028 also aligns with the EU's ongoing extensive revision of its pharmaceutical legislation, and lays the groundwork for the most significant reform of the EU medicines regulation in decades.

The six focus areas have been carefully chosen to support the network's core work of evaluating medicines as we take strides to promote the development of medicines and ensure that they reach those who need them.

Maria Lamas, Chair of the HMA Management Group

EMA and the HMA aim to finalise the strategy in the first quarter of 2025 with the final adoption expected by March 2025. Once finalised, the strategy will guide the work of EMA and the network until 2028.

Collaboration on digitalisation

Throughout 2024, EMA worked with its partners in the EU to accelerate and strengthen the digitalisation of services and operations.

The HMA/EMA Regulatory Optimisation Group (ROG) represents a key initiative in advancing the EMRN's digital transformation. Its focus is on aligning the NCA's IT strategies with IT systems and services managed by EMA, the so-called Network Portfolio. It does so by providing a platform for dialogue between EMA, the HMA, the NCAs and external stakeholders of the network.

A notable success in 2024 was the development of a stepwise model for the integration of the NCAs in the data qualification process, a vital step toward establishing Product Management Services (PMS) as a single source of medicinal product information.

As the network continues to evolve, it will need to take into account the diverse level of digitalisation across the EU Member States, as well as ensuring a more comprehensive digital interface to optimise interaction with our stakeholders and EU citizens more widely.

EMANS 2028

EMA and several EU partner agencies have joined forces to contribute insights on the use of trustworthy, human-centric artificial intelligence in the workplace to foster greater collaboration among EU agencies and Member States.

In 2024, the network of EU agencies (EUAN) elevated the AI virtual community to the EUAN Working Group on AI, building on its established governance frameworks and collaborative culture. The group is chaired by EMA.

With participation from 39 EU organisations, the Working Group achieved several strategic objectives, including assessing AI maturity levels, mapping use cases and developing actionable plans to advance AI integration across the EUAN. Key deliverables, such as the EU AI Innovation Fund Implementation Plan, the AI Maturity Assessment, and guidance on co-pilot implementation, provided a robust framework for future growth and collaboration.

The Working Group hosted numerous knowledge-sharing events through in-person and virtual workshops, fostering engagement, expanding the AI ecosystem, and establishing collective vision for 2025 to 2027. Through the development of shared services and solutions, coupled with the recognition of common challenges, the Working Group has emerged as a leading forum for advancing AI capabilities within the network.

The EU Network Training Centre– a decade of excellence

The post-pandemic era has accelerated technological advancement, introducing new ways of working and innovative digital solutions for adult learning. To keep pace with rapid developments in medicines regulation, the continuous enhancement of skills and sharing of expertise between EMA and national regulators remains essential.

The EU Network Training Centre (EU NTC), a strategic collaborative endeavour between EMA and EU Member States, promotes and ensures the sharing of best scientific and regulatory practices across the EMRN through the EU NTC Learning Management System (LMS).

The year 2024 marked a decade since the launch of the EU NTC. Key achievements over the last ten years include:

• implementation of the Learning Management System;
• development of a learning and development toolkit;
• launch of the EU NTC portal, an online platform offering scientific, regulatory and digital training for experts involved in EU regulatory procedures;
• monthly online newsletter with training offers;
• launch of the remuneration scheme for the development and delivery of training aimed at fulfilling a critical unmet learning need;
• extending access to the training catalogue to members of the Healthcare Professionals' Working Party (HCPWP) and the Patients' and Consumers' Working Party (PCWP);
• providing access to the EU NTC LMS to EU candidate countries in the context of the Instrument for Pre-accession Assistance (IPA);
• expansion of the training catalogue to include digital skills through the Digital Academy.

Looking ahead, the EU NTC plans to professionalise its training curricula, expand to new target audiences and pioneer digital approaches incorporating AI and immersive learning technologies.

EMA in the world

EMA and European medicines agencies network designated as a WHO Listed Authority

In 2024, WHO designated the EMRN as a WHO Listed Authority (WLA). This is the first regional regulatory system to receive this designation. It is recognition and a significant achievement for those involved in medicines regulation in the EU: the European Commission, EMA and the 31 national authorities of all EU Member States. This prestigious designation is recognition that the network meets international regulatory standards, guidelines and practices, which reinforces the EMRN's position as a global leader in medicines regulation.

I am delighted that the EU medicines network has now been officially recognised by WHO as a global reference authority, operating at the highest regulatory standards. This acknowledgement provides a formal basis for the important work that EMA and the EU are already doing to promote reliance practices globally. We will continue our commitment to ensuring that available medicines are safe, effective and of high quality, and look forward to our work with WHO and other regulatory authorities around the world to improve global public health.

Emer Cooke, EMA's Executive Director

Supporting the establishment of the African Medicines Agency: building global regulatory capacity

International collaboration is crucial for protecting public health beyond European borders. In 2024, EMA launched a five-year partnership to support the establishment of the African Medicines Agency (AMA), a specialised agency of the African Union (AU). The goal is to strengthen regulatory systems across Africa to improve patient access to safe and effective medicines while preventing substandard or falsified medicines from reaching the market and harming people. Throughout 2024, EMA and the EMRN shared its unique experience and regulatory model for continental medicines regulation to support the development of the AMA. Actions focused on:

• providing expertise to make the AMA operational and strengthening cooperation between European, African and international partners;
• capacity building for the African regulatory network;
• coordination of initiatives across the European network and partner organisations.

A key milestone in 2024 was EMA's grant to the African Medicines Regulatory Harmonisation (AMRH) initiative, led by the African Union Development Agency (AUDA-NEPAD). The grant funds a one-year pilot to test continent-wide procedures for medicines evaluation and inspections. It will help to develop processes, facilitate national authorisations of medicines and enhance information sharing.

Sharing knowledge and building capacity are at the heart of our collaboration. In June, EMA hosted two AMRH technical committees to share knowledge and provide insights into EMA's regulatory procedures that could inform the development of Africa's regulatory system.

Together with African partners and WHO, EMA identified key training areas and mapped expertise within the European network. Based on the insights, we invited national competent authorities in the EU to apply for grants to strengthen the scientific and regulatory expertise of national authorities in Sub-Saharan Africa.

EMA's efforts are part of a broader ‘Team Europe' initiative on manufacturing and access to vaccines, medicines and health technologies in Africa (MAV+), launched by the European Commission in 2021.

As African Medicines Regulatory Harmonisation (AMRH) lays the foundation for the AMA, our collaboration with EMA marks a crucial stride towards the realisation of the AMA's mission. Together, the AMRH and EMA will expedite the establishment of the AMA, fostering greater collaboration among African nations. This partnership not only signifies a shared commitment but also accelerates AMA's journey to becoming a beacon for regulatory efficiency and healthcare advancement in Africa.

Chimwemwe Chamdimba, Head of the AMRH initiative at AUDA-NEPAD

Leading the International Coalitionof Medicines Regulatory Authorities

As chair of the International Coalition of Medicines Regulatory Authorities (ICMRA), EMA spearheaded global efforts to strengthen regulatory cooperation on critical global health issues in 2024. Under EMA's leadership, ICMRA advanced strategic initiatives and projects to address common global challenges and harmonise regulatory standards. Key initiatives led by EMA focused on addressing:

• antimicrobial resistance;
• emerging public health threats, particularly mpox;
• mis- and disinformation on public health topics; and
• collaboration in pharmaceutical quality knowledge management.

Supporting the international fight against antimicrobial resistance

Since its inception, ICMRA has provided a platform for international regulators and other key stakeholders to develop strategic responses to antimicrobial resistance. At the 11th ICMRA Summit in November 2024, EMA co-chaired a crucial panel discussion on this topic where international regulators shared feedback and insights. This led to the publication of a statement reiterating the critical importance of preserving the effectiveness of antimicrobials and the crucial role regulators play in addressing the challenge collaboratively.

I cannot stress enough that we need a multidimensional approach. From the regulatory perspective, we can focus on the prudent use of existing treatments, enabling the development of novel antimicrobials, better use of vaccines, research on alternatives, and better diagnostic tools at the point of care.

Emer Cooke, EMA's Executive Director and Chair of ICMRA

Coordinating a global response to public health threats

Following WHO's August 2024 declaration of mpox as a public health emergency of international concern (PHEIC), ICMRA worked to align the global regulatory response. On 2 October 2024, EMA convened international regulators and WHO experts to discuss available knowledge supporting mpox medicine development and support measures to improve access to mpox medicines in the most affected countries during the ongoing outbreak.

EMA co-chaired the ICMRA working group on public health emergency clinical trials, and in this role the Agency led the development of a reflection paper in 2024 that outlines key opportunities, challenges and regulatory considerations for planning and conducting platform trials.

Addressing mis- and disinformation is high on the agenda of many regulators. In 2024 EMA led a project aiming to map the landscape of mis- and disinformation management and to identify effective response strategies among ICMRA members. Twenty-three regulatory authorities from different countries and regions (Europe, Asia, North and South America, Middle East and Australia) contributed to the project and provided information on their approaches, tools, challenges and successful initiatives to combat mis- and disinformation. The ICMRA Communications Group, which is chaired by EMA, is planning to facilitate the regular information sharing and exchange between ICMRA members to further foster collaboration to counter false narratives.

Pharmaceutical quality knowledge management system

ICMRA has been active in exploring a common Pharmaceutical Quality Knowledge Management System (PQKMS) facilitating collaboration and reliance with the aim to achieve faster changes in supply chains and thus improve the availability of medicines. In 2024, EMA, the US FDA and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) collaborated with several other regulatory authorities, including Health Canada (HC), Swissmedic, the UK Medicines & Healthcare products Regulatory Agency (MHRA), in two pilot programmes on:

• collaborative assessments of changes related to the supply of key medicines, which aim to enable greater cross-regional access to high-quality, critical medicines through parallel assessments and approvals in different regions; and
• hybrid inspections of manufacturing sites that allow multiple regulators to participate in a single inspection, either on-site or remotely, and take one joint regulatory decision, to maximise the use of limited resources.

The ICMRA PQKM project reached a major milestone in May 2024, when the initial phase of both pilots was completed. All collaborative assessments and hybrid inspections were finished within the agreed timelines and showed productive collaborations between regulators and industry. ICMRA published summary reports on each of the pilots in early 2025.