EUDRANET

EUDRANET (pronounced: /juːdrənɛt/) is a secure network that facilitates the exchange of information between the European Medicines Agency (EMA), the European Commission, and the Competent Authorities in the Member States of the European Union (EU) and the European Economic Area (EEA).

The term "EUDRANET" is an acronym derived from "EU" (European Union) and "DRANET" (Drug Regulatory Authorities NETwork).

EUDRANET is used for the exchange of information related to the regulation of medicinal products in the EU and EEA. This includes information on pharmacovigilance, clinical trials, marketing authorisation and post-marketing surveillance. The network is designed to ensure the secure and confidential transmission of data.

European Medicines Agency (EMA): The agency responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
European Commission: The executive branch of the EU, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Competent Authorities: The national bodies responsible for the authorisation of medicines and the supervision of their safety in the Member States of the EU and EEA.
Pharmacovigilance: The science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
Clinical trials: Research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention.
Marketing authorisation: The approval to market a medicinal product in one or more countries.
Post-marketing surveillance: The practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market.

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