Europe – HMA-EMA plans real-world metadata framework for regulatory decision-making

Officials at the Heads of Medicines Agencies – European Medicines Agency (HMA-EMA) are moving forward with an effort to create a usable catalogue of metadata to aid the scientific community in identifying real-world evidence that can inform regulatory decisions.

Metadata is defined generally as “a set of data that describes and gives information about other data” and can be further subcategorized by generation, location, ownership, and governance of the data; processes for storing, handling, and accessing the data; the origin and time span of data; data format; and descriptions of other variables captured in the data, such as quality measures.

In April 2021, HMA-EMA held a virtual technical workshop to review a preliminary list of metadata that could be used for characterizing real-world evidence, metadata definitions, regulatory use cases, and proposed options to collect and maintain a metadata catalogue…