How the European medicines network cooperates with other agencies and regulators
The European Medicines Agency (EMA) and the regulatory network around it work with regulators elsewhere, with the World Health Organization and with the other EU agencies: through a global coalition of regulators, WHO recognition of the network, support for a continental regulator in Africa, a joint One Health framework, and close work with European and international partners during health emergencies.
The global coalition of regulators
The International Coalition of Medicines Regulatory Authorities (ICMRA) was established in December 2013 by eight regulators to address a need for a global governance mechanism and stronger cooperation. In 2023, the year of its tenth anniversary, it had 38 members, with the WHO as an observer, and was chaired by EMA with co-chairs from ANVISA in Brazil and PMDA in Japan. The anniversary was celebrated at the coalition's annual summit and plenary in Melbourne on 13 to 16 November 2023, hosted by Australia's Therapeutic Goods Administration. There, members discussed the use of artificial intelligence and machine learning in medicine regulation, the evolution of clinical trials, and advanced medical products based on genes, cells or tissue engineering.
Over its first decade the coalition made significant progress in a range of areas at the heart of the work of many regulators worldwide, and its significant milestones included activities supporting the fight against antimicrobial resistance and the management of medicines shortages, as well as topics such as clinical trials, pharmacovigilance, regulatory convergence and reliance, innovation, real-world evidence, and alignment in the global COVID-19 response. Its major achievement is the leadership its members provided by working together during the COVID-19 pandemic. The coalition worked to expedite and streamline the development and approval of COVID-19 vaccines and treatments, helped to increase the efficiency and effectiveness of regulatory processes and decision-making, called for large, well-designed clinical trials so that regulators have solid evidence for decision-making, and organised workshops on the manufacturing, safety and efficacy of COVID-19 vaccines. In June 2023 it received the Global Award for Outstanding Contribution to Health at the Drug Information Association's Global Annual Meeting. The coalition will continue to address current and emerging regulatory and safety challenges for human medicines, strengthen collaboration and communication, and enhance the quality, safety and efficacy of medicines for the benefit of patients worldwide.
Collaboration with the WHO
A WHO Listed Authority is a regulatory authority or regional regulatory system judged to comply with all the indicators and requirements the WHO specifies. The WHO runs the WHO Listed Authority initiative to promote access to and supply of safe, effective and high-quality medical products, and the initiative ensures optimal use of limited global regulatory resources by facilitating reliance on the work and decisions of trusted regulatory authorities. The reliable and highly performing listed authorities can be used as a reference point by regulatory authorities that lack the resources to perform all necessary regulatory functions, or that have not yet reached higher maturity levels for medical product oversight. Overall, the WHO Listed Authority framework is expected to promote confidence and reliance while fostering regulatory convergence, harmonisation of approaches and international cooperation.
By 20 May 2024 the WHO had designated the European medicines regulatory network a WHO Listed Authority, recognising its members, the European Commission, EMA and the 30 national authorities of the European Economic Area Member States, as meeting international regulatory standards, guidelines and practices. The designation followed a comprehensive assessment by the WHO, facilitated by the Steering Group for Benchmarking of European Medicines Agencies. It covers each individual regulatory authority of the network as well as the network overall, which is recognised as a single entity and has also been designated a regional regulatory system. Collaboration with the WHO is specifically highlighted in the legislation establishing EMA, and the designation complements the two organisations' cooperation in global public health networks and initiatives.
On 1 September 2025 EMA and the WHO marked a decade of formal collaboration and shared commitment to address global health challenges. Since the signing of a confidentiality arrangement in September 2015, their partnership has focused on cooperation on scientific evaluation, capacity building and enhancing regulatory efficiency to contribute to public health worldwide. A key initiative for the collaboration is EMA's EU Medicines for all (EU-M4all) programme, which enables EMA, in cooperation with the WHO, to support global regulatory capacity building and contribute to the protection and promotion of public health beyond the EU. By September 2025 the latest example of this successful programme was EMA's July 2025 recommendation for Yeytuo (lenacapavir), a new medicine for pre-exposure prophylaxis against sexually acquired HIV-1 in adults and adolescents at high risk of becoming infected. Experts from Uganda, Zambia, Kenya, Nigeria, Zimbabwe, South Africa, Thailand and Vietnam took part in its evaluation, as did the WHO. This inclusive approach supports regulatory harmonisation and strengthens global capacity to protect public health. Since the confidentiality arrangement was signed, the WHO, the European Commission's Directorate-General for Health and Food Safety (DG SANTE) and EMA have worked closely together in areas strategically important to them and to the European medicines regulatory network. The partnership has enabled high-impact cooperation in these key areas:
- addressing existing and emerging public and animal health threats
- accelerating access to essential medicines through mechanisms such as the EU-M4all procedures, the OPEN framework, support to the clinical development of vaccines and contribution to disease areas
- encouraging good reliance practices to promote effective use of global regulatory resources
- ensuring the quality and safety of medicines through cooperation on pharmacovigilance and inspections
- establishing strategic partnerships, including WHO Listed Authority designation, global regulatory fora, regional engagements and financial support
- supporting research and development of medicines
- promoting capacity building and regulatory harmonisation
Support for the African Medicines Agency
The African Medicines Agency will be a specialised agency of the African Union dedicated to improving equitable access to quality, safe and effective medical products in Africa. By 26 January 2024, 27 countries had ratified its treaty, and more African Union members were expected to complete the process in the following months. Its creation is a unique opportunity to facilitate the regulation and oversight of key medicines at continental level, promoting collaboration among African countries and regions.
EMA's involvement in the African Medicines Agency project officially started in December 2023, when it received a contribution from the European Commission to support the setting up of the African Medicines Agency. On 26 January 2024 EMA announced that it would harness its unique experience in coordinating intra-regional medicines regulation to support the strengthening of the African regulatory network. EMA had received a grant of ten million euros from the European Commission to support regulatory systems at national and regional level in Africa, and in particular the setting up of the African Medicines Agency, in collaboration with African, European and international actors. The Commission's Directorate-General for International Partnerships signed an agreement with EMA marking the project's official launch. The European medicines regulatory network will share with the African Medicines Agency its experience in pooling resources and coordinating work to regulate medicines efficiently and effectively, ensuring high-quality standards and use of the best available expertise, reducing administrative burden so that medicines reach patients faster, and accelerating the exchange of information on critical issues such as medicines safety. EMA committed to mobilising experts to support the African Medicines Agency, its technical committees and African regulators in setting up its governance and its scientific and administrative processes, and it would also offer training, together with experts from EU Member States, to reinforce scientific and regulatory expertise in the evaluation and supervision of medicines. EMA's part in the project falls within the EU's Global Gateway strategy and the Team Europe initiative on manufacturing and access to vaccines, medicines and health technologies in Africa (MAV+). The Commission launched the initiative in May 2021, and under the Global Gateway strategy it had mobilised 1.3 billion euros by 26 January 2024, including around 135 million euros in grants for regulatory strengthening. Working together with EU Member States, African partners such as the African Union Development Agency (AUDA-NEPAD) and the WHO, the EU will help to strengthen regulatory capacity in Africa with a comprehensive set of actions at continental, regional and national levels.
By 30 July 2024 EMA had awarded a grant to the African Medicines Regulatory Harmonisation (AMRH) initiative of AUDA-NEPAD to support a pilot testing procedures for the joint continental evaluation of medicines in Africa. By then AUDA-NEPAD had worked on harmonisation activities for a decade, paving the way for the creation of the African Medicines Agency. The continental pilot is one of these activities, which aim to validate procedures and processes before the African Medicines Agency is established. The pilot, co-funded with the Bill & Melinda Gates Foundation, was to run for a year. During the pilot, the AMRH Evaluation of Medicinal Products Technical Committee was to evaluate the quality, safety and efficacy of priority medicinal products with the support of the continental Good Manufacturing Practices Technical Committee. The learnings from the evaluations will help to develop continental processes and procedures, facilitate national authorisations of recommended medicines, and strengthen information sharing and reliance. The two AMRH technical committees visited EMA in June 2024 to share knowledge and gain insight into its regulatory procedures and processes, which could serve as a possible model for the African continental regulatory system. EMA and the European medicines regulatory network will continue to make their unique experience and expertise in continental medicines regulation available to support the establishment of the African Medicines Agency, providing technical expertise and training both online and in person.
One Health with the other EU agencies
One Health recognises the complex interplay between human, animal and plant health, food safety, the climate crisis and environmental sustainability. Implementing this approach across sectors will be key to making the EU and its Member States better equipped to prevent, predict, detect and respond to health threats. It will mitigate the impact and societal cost of such threats, or even prevent their emergence, while also helping to reduce human pressures on the environment and safeguarding key societal needs such as food security and access to clean air and water.
In November 2023 the European Centre for Disease Prevention and Control, the European Chemicals Agency, the European Environment Agency, the European Food Safety Authority and EMA, which provide scientific advice on the environment, public health and food safety, issued a joint statement expressing their shared commitment to supporting the One Health agenda in Europe. On 7 May 2024 the five agencies published a joint framework for action to strengthen their cooperation in support of the One Health agenda's implementation in the EU. At the framework's launch their Executive Directors reinforced their commitment to the One Health approach in a joint video statement. A cross-agency task force will work on implementing the framework over the three years from 2024 to 2026, focusing on five strategic objectives: strategic coordination, research coordination, capacity building, stakeholder engagement and joint inter-agency activities. This will ensure that the agencies' scientific advice is increasingly integrated, that the evidence base for One Health is strengthened, and that the agencies are able to contribute with a common voice to the One Health agenda in the EU.
Cooperation during health emergencies
During a health emergency such as the Zika virus outbreak, EMA works closely with European bodies, including the European Commission and the European Centre for Disease Prevention and Control, and with international partners such as the WHO and other international regulators from affected countries.