EMA and WHO Celebrate 10-Year Collaboration

The European Medicines Agency (EMA) announced on Sept. 1, 2025 that the agency is celebrating its 10-year collaboration with the World Health Organization (WHO) (1). The two agencies signed a confidentiality arrangement in September 2015 (2) to focus on “scientific evaluation, capacity building, enhancing regulatory efficiency to contribute to public health worldwide.”

What has the collaboration fostered?

One specific initiative the two agencies have collaborated on is the EU Medicines for all (EU-M4all) program. This program enables EMA to support global regulatory capacity to protect and promote public health beyond the European Union. In July 2025, the HIV-1 pre-exposure prophylaxis (PrEP), Yeytuo (lenacapavir),was recommended by EMA’s Committee for Medicinal Products for Human Use (CHMP) for approvalfor adults and adolescents at high risk of becoming infected (3). The drug was not only evaluated by CHMP for use in the EU, but also by WHO, and experts from Uganda, Zambia, Kenya, Nigeria, Zimbabwe, South Africa, Thailand, and Vietnam. “This inclusive approach supports regulatory harmonization and strengthens global capacity to protect public health,” EMA stated in the press release (1).

“HIV-1 infection is of major public health significance. According to the WHO, in 2024 an estimated 1.3 million people became newly infected with HIV globally, including 160,000 new HIV infections in the European region and 650,000 in Africa, the region most affected by HIV,” the agency stated in the release at the time (3). “PrEP is a cornerstone of HIV-control efforts in Europe and worldwide and is very effective at preventing infections if taken as prescribed. However, uptake and adherence are often suboptimal because access to some medicines is limited, and other available medicines require strict daily intake. This means that many people at risk in the EU and globally remain underserved by existing PrEP options, highlighting an urgent need to develop additional PrEP modalities.”

Working together to harmonize efforts

Accelerating access to important medicines has also been done through support of clinical development of vaccines and the OPEN framework, where several regulators evaluate a drug parallel with EMA to share expertise, harmonize regulatory approaches, and increase transparency. The partnership between the two agencies has also addressed emerging public health threats, encouraged good reliance practices, ensured quality and safety of drugs through inspections, established strategic partnerships, and promoted regulatory harmonization.

"Global health relies on trusted partnerships. In a very unpredictable world where public health issues go beyond national borders, these partnerships are more necessary today than ever,” Emer Cooke, EMA’s executive director, stated in a press release (1). “Even though EMA’s mandate focuses on Europe, this partnership with the WHO shows that there is a societal value in sharing information, resources and collaborating, and that this can impact people’s lives. EMA remains committed to supporting global efforts and protecting public health with the WHO in the EU and beyond."

References

1. EMA. EMA and WHO Mark Ten Years of Collaboration to Advance Global Access to Medicines. Press Release. Sept. 1, 2025. https://www.ema.europa.eu/en/news/ema-who-mark-ten-years-collaboration-advance-global-access-medicines
2. EMA. Confidentiality Arrangement, World Health Organization (WHO). EMA.europa.eu. https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/world-health-organization-who#confidentiality-arrangement-11285 (accessed Sept. 2, 2025).
3. EMA. New Injection for Easier Prevention of HIV Infection in the EU and Worldwide. Press Release. July 25, 2025. https://www.ema.europa.eu/en/news/new-injection-easier-prevention-hiv-infection-eu-worldwide