Pharmacogivilance

Real-World Evidence (RWE) can be leverage to bring new medications to market, evaluate the safety and effectiveness of existing medications for new uses, and assess the continued performance and safety of products once on the market, across the drug total life cycle. The FDA, Health Canada and the European Medicines Agency are starting to rely on RWE to support their regulatory decisions to help speed patient access to innovations that advance public health.

Regulatory bodies have a long history of using RWE to monitor and evaluate the safety of drug products after they are approved (post-market). However, there is significant interest in and gradual acceptance of a potentially broader role for RWE in regulatory decision-making. For example, the FDA has accepted RWE to support drug product approvals, primarily in the setting of oncology and rare disease, areas in which clinical trials are challenging to do.