GVP

Origin

The GVP framework was formally established by the European Medicines Agency (EMA) in the European Union to harmonize and standardize pharmacovigilance activities across member states. Its creation was a direct response to the need for more robust, proactive, and globally aligned drug safety systems following earlier, less structured approaches. The core principles of GVP are rooted in the necessity for continuous risk-benefit assessment and the prompt communication of safety information to both healthcare professionals and the public. This structured approach has since influenced safety standards worldwide.

Mechanism

GVP operates by defining specific, auditable standards for key pharmacovigilance processes, including the establishment of a pharmacovigilance system master file, the systematic collection of individual case safety reports, and the production of periodic safety update reports. The mechanism requires companies to have qualified personnel and documented procedures to detect, analyze, and evaluate safety signals effectively. Regular inspections and audits ensure that these practices are consistently followed, thereby guaranteeing that safety data is handled with the scientific rigor required for accurate risk assessment.