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.

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:

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

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

Update: 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

For more information, see the exchange of letters:

Facilitating access to medicines in low- and middle-income countries

EMA cooperates with the WHO to provide scientific advice and/or scientific opinions on medicines intended for markets outside the EU under the 'Article 58' procedure. To be eligible, medicines must be intended for use to prevent or treat diseases of major public health interest, including vaccines used in the WHO Expanded Programme on Immunization. For more information, see Obtaining and maintaining a scientific opinion on a medicine for use outside the European Union.

Since November 2014, EMA participates in a pilot project led by the WHO to facilitate the registration of medicines in non-EU countries where regulatory resources may be limited. The pilot involves allowing marketing-authorisation holders of centrally authorised medicines, or holders of Article 58 opinions, to share the full assessment reports and inspection reports with the authorities in non-EU countries where they seek authorisation. The aim is to accelerate the approval process based on the EMA assessment, while allowing competent authorities which might have limited regulatory resources to fulfil their regulatory responsibilities and make their own decisions.

Initial results from the pilot, involving a medicine to treat HIV in children, resulted in successful registration in 5 out of 11 African countries where authorisation was sought, in under 7 months compared with average registration times of over 24 months.

Other areas of cooperation

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

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.

As part of the 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 Certificates of medicinal products.

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