The formal collaboration between the European Medicines Agency (EMA) and the World Health Organisation (WHO) has reached its 10th anniversary in September 2025. It has been a long journey, during which the two organisations have shared their commitment to addressing global health challenges. The partnership began with the signing of a confidentiality agreement in September 2015, after which the focus shifted to cooperation in scientific evaluation, capacity building, and enhancing regulatory efficiency in order to contribute to public health worldwide.
One of the main joint initiatives is the EMA’s EU Medicines for all (EU-M4all) programme, which supports the development of global regulatory capacity and contributes to the protection and promotion of public health beyond the EU. Other key areas of high-impact cooperation include existing and emerging threats to public and animal health, and ensuring more rapid access to essential medicines through various mechanisms. Good reliance practices aim to promote the effective use of global regulatory resources. Other examples of collaboration include cooperation on pharmacovigilance and inspections, and strategic partnerships to ensure the quality and safety of medicines, including EMA’s WHO Listed Authority (WLA) designation.