RWE in Europe is ‘evolving’ with the launch of new DARWIN EU® institution

The European Medicines Agency (EMA, Amsterdam, The Netherlands) has launched a new Coordination Centre as part of continuous efforts to utilize real-world evidence (RWE) in regulatory processes. The institution forms part of the Data Analysis and Real World Interrogation Network (DARWIN EU®). It is hoped that the Coordination Centre will develop and manage real-world data (RWD) and execute research requested by regulators and stakeholders.  The Coordination Centre will provide the EMA and European Union members with access to reliable RWE. Types of RWD included in the institution include disease instance and burden, alongside the safety and efficacy of medicines and...