World Health Organization (WHO)

The World Health Organisation (WHO) is an important partner for contacts with regulatory authorities, particularly those with whom the European Medicines Agency (EMA) does not have a confidentiality arrangement. Collaboration with the WHO is specifically highlighted in the legislation establishing the Agency, with reference to scientific harmonisation, technical cooperation and international collaboration on pharmacovigilance.

Added on 1 July 2024:
'Designation of the European network as a WHO-Listed Authority' section

Updated on 1 July 2024:
'Facilitating access to medicines in non-EU countries'

Confidentiality arrangement

A confidentiality arrangement between the 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.

Transfer of data on suspected adverse reactions

As of 2017, EMA operates a regular transfer of data on suspected adverse drug reactions occurring in the EU to WHO's Uppsala Monitoring Centre (UMC). 

The data comes from the EudraVigilance system and contributes to WHO's global database of individual case safety reports, VigiBase. The UMC manages VigiBase on behalf of the WHO Programme on International Drug Monitoring.

EU Member States, EMA and other countries and stakeholders consult VigiBase when investigating risks with medicines.

The framework allowing EMA to make all suspected adverse reaction reports occurring in the EU promptly available to WHO is a legal requirement under Article 28c of Regulation (EC ) No 726/2004.

For more information, see:

• Uppsala Monitoring Centre
• EudraVigilance
• VigiBase
• WHO Programme on International Drug Monitoring
• Regulation (EC ) No 726/2004

EMA, WHO and the UMC updated the conditions for data transfer in 2020, in line with EU legislation on personal data protection and the EudraVigilance access policy. These conditions have been reviewed by EMA, WHO and UMC in 2022 and remain valid.

For more information, see the exchange of letters:

Letter from EMA on conditions for making available reports of suspected adverse reactions by EMA to WHO/UMC

Reference Number: EMA/308793/2020

Response from WHO to letter from EMA on conditions for making available reports of suspected adverse reactions by EMA to WHO/UMC

Response from UMC to letter from EMA on conditions for making available reports of suspected adverse reactions by EMA to WHO/UMC

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)

Facilitating access to medicines in non-EU countries

EMA cooperates with the WHO to provide scientific advice and / or scientific opinions on medicines for use outside the European Union under the 'EU-M4all' procedure. 

Eligible medicines must be intended for use to prevent or treat diseases of major public health interest, including vaccines used in the WHO Expander Programme on Immunization. 

For more information on this initiative, see:

• Medicines for use outside the European Union
• Obtaining and maintaining a scientific opinion on a medicine for use outside the European Union
• WHO Expanded Programme on Immunization

Since 2015, EMA participates in the WHO collaborative registration procedure based on reliance.

Marketing authorisation holders of centrally authorised products can use this mechanism to facilitate and expedite the assessment of their products in the participating countries.

National authorities of the participating countries can base their decisions on the evaluation already carried out by a trusted regulatory authority, such as EMA. WHO supports and monitors interactions between all parties.

For more information, see:

• WHO collaborative procedure for registering medicines through reliance

Other areas of cooperation

EMA and WHO regularly participate in a range of collaborative activities including:

• the development of International non-proprietary names;
• monitoring of the safety of medicines in cooperation with WHO's Uppsala Monitoring Centre and the WHO Programme on International Drug Monitoring;
• good clinical practice and good manufacturing practice inspections and guidance;
• strengthening of regulatory systems in WHO member countries;
• vaccines;
• pandemic and seasonal influenza activities;
• possible pathways for the development, evaluation and approval of medicines to fight Ebola.

For more information, see:

• International non-proprietary names
• WHO Programme on International Drug Monitoring
• Ebola

EMA, the European Commission and the WHO have a long history of multilateral scientific and technical collaboration including in the context of the International Council on Harmonisation and the International Pharmaceutical Regulators Forum.

EMA contributes to a number of WHO initiatives including Make Medicines Child Size and the Paediatric Medicines Regulators' Network. This is a network of national medicines regulatory authorities set up by the WHO in 2010, which promotes the quality and availability of medicines for children and contributes to capacity-building.

For more information, see:

• International Council on Harmonisation
• International Pharmaceutical Regulators Forum
• Paediatric Medicines Regulators' Network

As part of the WHO certification scheme, EMA issues certificates of medicinal products to confirm their marketing-authorisation status if they have been authorised through the centralised procedure, or to confirm that a centralised marketing-authorisation application has been submitted in accordance with the WHO certification scheme. The purpose of this certification scheme is to support the work of health authorities outside the European Union, in particular those in developing countries. 

For more information, see:

• Certification of medicinal products