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.
Other areas of cooperation
EMA and WHO regularly participate in a range of collaborative activities including:
- provision of scientific advice and/or scientific opinions on 'Article 58' medicines, which are intended for markets outside the European Union. Medicines eligible for the procedure are used 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.
- the development of International non-proprietary names;
- monitoring of the safety of medicines in cooperation with of WHO's Uppsala Monitoring Centre and the WHO programme for 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 Conference 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.
How useful is this page?
Average rating:Based on 13 ratings
Add your rating:
- See all ratings
9 ratings0 ratings0 ratings2 ratings2 ratings
- World Health Organization (WHO)
- Report on the Eastern Mediterranean Drug Regulatory Authorities Conference 2014
- International Conference on Harmonisation
- International Pharmaceutical Regulators Forum
- International non-proprietary names
- Make Medicines Child Size
- Paediatric Medicines Regulators' Network
- Uppsala Monitoring Centre