Glossary
The Paul-Ehrlich-Institut has developed the definitions in this glossary to help users understand regulatory and biomedical terminology. Definitions may differ from those given in German and European Union legislation and medicine. Many definitions correspond to the glossary entries on the pages of the European Medicines Agency (EMA).
EDQM – European Directorate for the Quality of Medicines & HealthCare
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate of the Council of Europe responsible for the maintenance and development of the European Pharmacopoeia and the coordination of the Official Medicines Control Laboratories (OMCL) network. Experts from the Paul-Ehrlich-Institut work in various EDQM working groups.
EMA - European Medicines Agency
The European Medicines Agency (EMA) is a European Union agency based in Amsterdam, which is responsible for the scientific evaluation and monitoring of medicines.
EPAR - European Public Assessment Report
European Public Assessment Report (EPAR): A set of documents describing the evaluation of a medicine authorised by the centralised procedure and including the product information, published on the European Medicines Agency website. European public assessment reports include the product information.
EudraCT
A database that includes information on clinical trials taking place in the European Union and clinical studies conducted worldwide in accordance with a paediatric investigation plan. A subset of the data is publicly accessible via the European Clinical Trials Register.
Further Information:
European medicines regulatory network
A network of European centres in the fields of pharmacoepidemiology and pharmacovigilance, which aims to strengthen the post-authorisation monitoring of medicines by facilitating the conduct of multicentre, independent, post-authorisation studies focusing on the safety and on the risk/benefit balance. It is coordinated by the European Medicines Agency; abbreviated as ENCePP.