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.
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 DG SANTE, EMA and the WHO
- WHO confirmation letter on the working arrangement to exchange non-public information on medical products between the European Commission's DG SANTE, EMA and the WHO
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
In December 2015, EMA agreed the conditions for direct transfer of data on suspected adverse reactions occurring in the EU to the Uppsala Monitoring Centre (UMC) that had been developed through close collaboration between EMA, WHO and the UMC. More information on the agreements is available in the letter from EMA , together with the response from WHO and the response from the UMC .
The data contribute to VigiBase, the WHO global database of individual case safety reports, which the UMC manages 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.
Following technical development and testing of the data transfer system between EMA and the UMC from 2016-2017, a successful independent audit confirmed that the system meets the requirements. EMA operates regular data transfer from the new EudraVigilance system to VigiBase as of 22 November 2017.
EMA and the UMC will monitor the data transfer through regular teleconferences. EMA, the UMC and WHO will review the agreed conditions for a possible update in November 2019.
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. The conditions are in line with EU legislation on personal data protection and reflected in the revised EudraVigilance access policy .
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 Article 58 applications: Regulatory and procedural guidance.
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:
- 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;
- pandemic and seasonal influenza activities;
- possible pathways for the development, evaluation and approval of medicines to fight 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.
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.