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A key initiative for collaboration is EMA’s EU Medicines for all (EU-M4all) programme that 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. The latest example of this successful initiative is a recommendation issued by EMA in July 2025 for Yeytuo (lenacapavir), a new medicine for pre-exposure prophylaxis (PrEP) against sexually acquired human immunodeficiency virus type 1 (HIV-1) in adults and adolescents at high risk of becoming infected. In addition to WHO, experts from Uganda, Zambia, Kenya, Nigeria, Zimbabwe, South Africa, Thailand and Vietnam participated in the evaluation. This inclusive approach supports regulatory harmonisation and strengthens global capacity to protect public health.
Since signing their confidentiality arrangement, the WHO, the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) and EMA have worked closely together in areas that are strategically important for them as well as for the European medicines regulatory network. This partnership with the WHO has enabled high-impact cooperation in several key areas:
- Addressing existing and emerging public and animal health threats;
- Accelerating access to essential medicines through various mechanisms, such as the EU-M4All procedures, OPEN framework, support to clinical development of vaccines and contribution to disease areas;
- Encouraging good reliance practices to promote effective use of global regulatory resources;
- Ensuring quality and safety of medicines through cooperation on pharmacovigilance and inspections;
- Establishing strategic partnerships, including WHO Listed Authority (WLA) designation, global regulatory fora, regional engagements and financial support;
- Supporting research and development of medicines; and
- Promoting capacity building and regulatory harmonisation.
An overview of key interactions and joint initiatives is published today.
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