The EC and the EMA have agreed with the World Health Organisation (WHO) to share certain non-public information on the safety, quality and efficacy of medicines already authorised or under review in the European Union, or pre-qualified or under review by WHO. This cooperation will strengthen communication between the respective organisations and make it easier to protect public health. 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 cooperation between the organisations started on 01 September 2015. http://tinyurl.com/ngmwhcf