The European Medicines Agency’s (EMA) Good Pharmacovigilance Practices (GVPs) provide a framework for the monitoring and reporting of adverse drug reactions (ADRs) to ensure the safety and efficacy of medicines. In the context of real-world evidence, GVPs play an important role in ensuring the quality and reliability of data collected from real-world studies.

Real-world evidence refers to data collected from sources outside of traditional clinical trials, such as electronic health records, patient registries, and observational studies. This type of data is becoming increasingly important in drug development and regulatory decision-making, as it provides valuable insights into how medicines perform in real-world settings.

To ensure the quality and reliability of real-world evidence, GVPs require that data collection methods are standardized and that the data is collected in a manner that minimizes bias and confounding factors. GVPs also require that adverse events are reported in a timely and accurate manner, and that data is regularly monitored for safety signals.

In addition, GVPs require that all stakeholders involved in the collection and use of real-world evidence are trained (as appropriate) in pharmacovigilance principles and are aware of their responsibilities in ensuring the safety and efficacy of medicines.

By adhering to GVPs in the context of real-world evidence, researchers and regulatory agencies can ensure that the data collected is of high quality and can be used to inform decision-making related to the safety and efficacy of (approved) medicines.