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DARWIN EU

Data Analysis and Real World Interrogation Network

Basic data

Field

International

Date

01/02/2022 - 31/01/2027

Industry

Salud

Budget

Funded by

EU and EMA

Website

Video

PROJECT INFORMATION

DESCRIPTION

DARWIN EU® is an initiative of the European Medicines Agency (EMA) to provide reliable evidence on the use, safety and efficacy of medicines for human use (including vaccines) from real healthcare databases across the European Union (EU). The DARWIN EU® Coordination Center will support the EMA in building a distributed data network ("DARWIN EU® Data Partners Network"); conduct studies that answer research questions that support regulatory decision-making by the EMA's scientific committees and the European drug regulatory network; and maintain a catalog of data sources for use in the regulatory context and their metadata.

DARWIN EU® is an initiative of the European Medicines Agency (EMA) to provide reliable evidence on the use, safety and efficacy of medicines for human use (including vaccines) from real healthcare databases across the European Union (EU). The DARWIN EU® Coordination Center will support the EMA in building a distributed data network (“DARWIN EU® Data Partners Network”); conduct studies that answer research questions that support regulatory decision-making by the EMA’s scientific committees and the European drug regulatory network; and maintain a catalog of data sources for use in the regulatory context and their metadata.

Impact

The DARWIN database will include diseases, population groups, drug or vaccine use, efficacy, outcomes and safety of treatments. And it will do so over time. Sharing this data between countries will allow the conclusions to be open and transparent. What is good for Germany will be good for Italy or Spain, and vice versa.

But it will also allow us to know the differences and to be able to look for an explanation. In this way, when a rule is not met, it will allow finding why the expected result in a country or region may differ, if that is the case. This means that, indirectly, we will be measuring how the customs and habits of a population influence the results of treatments and vaccines.