EMA trials new data registry system
The reforms would also aid the establishment of new registries
A new initiative aimed at making better use of patient registries to source high-quality post-authorisation data has been launched by the European Medicines Agency (EMA). The reforms would also aid the establishment of new registries. Registries collect information on patients diagnosed with a particular disease or who receive particular treatments.
The Agency is assessing how best to use and unite existing registries to achieve these tasks. For instance, regulators sometimes require pharmaceutical companies to establish a registry obtaining information from clinical use of a medicine. Information is available from existing registries operated by physicians’ associations or national agencies.
An EMA note said: 'Companies and regulators sometimes face challenges in using existing registries, including differences in requirements for types and structure of data provided. In cases where no suitable registry is available, a new registry will need to be established...' The new initiative will over two years pilot ways of dealing with these challenges, working under a cross-committee task force.