World Health Organization (WHO)

The European Medicines Agency (EMA) works together with the World Health Organization (WHO) on a wide range of initiatives related to medicine regulatory topics, scientific assessment of medicines and capacity building to advance global public health.

The EMA-WHO partnership is built on a shared commitment to advancing global public health. Its key priorities include:

• Achieving universal health coverage;
• Promoting global health equity;
• Following WHO's Sustainable Development Goals.

High-level strategic alignment between EMA, WHO, and the broader European medicines regulatory network is essential to their joint work. This alignment allows them to focus on:

• Accelerating access to safe, effective, quality-assured medicines and vaccines through joint scientific efforts and safety monitoring;
• Building local capacities to ensure continuous access to health technologies;
• Enhancing emergency response and crisis preparedness to protect vulnerable populations;
• Promoting regulatory harmonisation to strengthen national health systems;
• Encouraging reliance practices to streamline regulatory decisions and avoid duplication;
• Supporting prequalification opinions to ensure high-quality medicines;
• Engaging in multilateral initiatives to align actions on global health priorities and policies;
• Strengthening the resilience of health systems in low and medium-income countries.

The partnership with WHO also enables EMA to collaborate with authorities with whom it does not have a confidentiality agreement.

For more information, see:

• Multilateral coalitions and initiatives
• World Health Organization
• World Health Organization: Sustainable Development Goals

In this section

Medicines for use outside the European Union

Under the 'EU-M4all' procedure, EMA and WHO provide scientific opinions on high-priority medicines for use outside the EU

WHO collaborative procedure for registering medicines through reliance

This procedure allows marketing authorisation holders of centrally authorised medicines to make them available in participating countries

OPEN framework

EMA collaborates with non-EU regulators, including WHO, in the parallel scientific evaluation of selected medicines

Certification of medicinal products

As part of the WHO certification scheme, EMA issues certificates of medicinal products to confirm their marketing authorisation status to support the work of non-EU authorities

Transfer of data on suspected adverse reactions

EMA regularly transfers data on suspected adverse drug reactions in the EU to the WHO Uppsala Monitoring Centre

Accelerating Clinical Trials in the EU (ACT EU)

EMA manages the ACT EU initiative fostering collaboration with stakeholders, including WHO, to advance how clinical trials are initiated, designed and run

Public health threats

EMA works with WHO on addressing cross-border and emerging health threats, public health emergencies, vaccines, shortages and global health products

Compliance: Overview

EMA and WHO collaborate to strengthen global regulatory oversight and promote high standards for medicine quality and safety worldwide

Overview of EMA-WHO partnership

An overview of the many areas of collaboration between EMA and WHO is available, covering interactions and joint initiatives in areas such as:

• Public health priorities;
• Support of low- and middle-income countries assessing essential medicines and vaccines;
• Capacity building through training and convergence of standards.

EMA continues to strengthen its regulatory and scientific collaboration with WHO in areas of strategic importance to both the authorities and the network.

Read overview of EMA-WHO partnership

Confidentiality arrangement

A confidentiality arrangement between EMA, the European Commission's Directorate-General for Health and Food Safety (DG SANTE) and the World Health Organization (WHO) has been in place since 1 September 2015. This complements cooperation between these organisations in the context of global networks and initiatives.

The arrangement covers certain non-public information on the safety, quality and efficacy of medicines already authorised or under review in the European Union (EU), or pre-qualified or under review by the WHO.

Letter on the working arrangement to exchange non-public information on medical products between the European Commission's Directorate General for Health and Food Safety (DG SANTE), European Medicines Agency and the Worl...

World Health organization's (WHO) confirmation letter on the working arrangement to exchange non-public information on medical products between the European Commission's Directorate General for Health and Food Safety (DG...

Under the arrangement, EMA, the European Commission and the WHO may share a range of information including:

• post-authorisation pharmacovigilance data, particularly related to adverse drug reactions as well as safety concerns arising from periodic safety update reports, and post-authorisation obligations and commitments;
• information in applications for scientific advice, orphan medicine designation, marketing authorisation or post-authorisation activities of significant public health interest, and applications for agreement of paediatric investigation plans;
• data related to inspections, manufacturing facilities and clinical research activities and related reports.

This should accelerate patients' access to new and innovative medicines, avoid duplication of assessments and improve the authorisation and safety of medicines by involving the best expertise from both sides.

Designation of the European network as a WHO-Listed Authority

In May 2024, WHO designated the European medicines regulatory network, composed of the European Commission, EMA and the thirty-one national competent authorities of the European Economic Area Member States, as a WHO-Listed Authority.

This means that WHO officially recognises the European network as a global reference authority that meets the highest regulatory standards and operates at an advanced level of performance.

The European network is the first regional regulatory system to receive this designation.

The WHO-Listed Authority framework aims to: 

• Provide a transparent and evidence-based pathway for regulatory authorities to be globally recognised
• Promote global access and supply of safe, effective and high-quality medicines
• Facilitate reliance on the work and decisions of trusted regulatory authorities to ensure optimal use of limited regulatory resources

It replaces the Stringent Regulatory Authority designation mechanism.

For more information, see:

• WHO Listed Authorities (WLA)
• List of WHO Listed Authorities
• European medicines network designated as WHO listed authority (20/05/2024)