World Health Organization (WHO)

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:

• 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.