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…