EMA — European Medicines Agency
Overview
The European Medicines Agency (EMA) is the decentralised EU regulatory authority responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union. For clinical research and open data, EMA defines the data standards and submission formats required for regulatory approval, including mandatory use of CDISC standards (SDTM and ADaM) for electronic clinical trial data submissions. EMA operates EudraVigilance, the EU pharmacovigilance database, and interfaces with the CTIS clinical trials information system, which became mandatory for new EU clinical trial applications from January 2023. EMA’s policy on publication of clinical data and its clinical data transparency programme directly shapes the open data landscape for regulatory trials in the EU.
Connections
- relatedTo: CDISC (EMA mandates CDISC SDTM and ADaM standards for electronic regulatory clinical trial data submissions)
- relatedTo: CTIS (EMA operates the CTIS clinical trial information system, mandatory for EU trial registration since January 2023)