The European Commission and the European Medicines Agency (EMA) have agreed with the World Health Organization (WHO) to share 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 WHO.
This cooperation will strengthen communication between the respective organisations and make it easier and quicker to take action to protect public health. The arrangement is expected to accelerate patients’ access to new and innovative medicines in the EU, avoid duplication of assessments and improve the authorisation and safety of medicines by involving the best expertise from both sides.
The arrangement further strengthens the collaboration between WHO, the European Commission and EMA who have a long history of scientific and technical collaboration in the context of the International Conference on Harmonisation and the International Pharmaceutical Regulators Forum.
Under the confidentiality arrangement, the organisations involved may share information such as:
–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 strengthened cooperation started on 1 September 2015.
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