The Medicines Risk-based Surveillance (MedRS) tool is a free web-based platform that automates the development of sampling protocols for post-marketing quality surveillance utilizing a risk-based approach. The tool applies risk management principles to evaluate multiple factors in several dimensions of risk for medicines, geographic locations and facilities/outlets within the supply chain. By using this tool, it is possible to identify the most susceptible medicines to be collected, prioritize collection at the most vulnerable locations and determine the number of samples required for a statistically significant assessment.

Subject area:
Regulatory System Strengthening

Objectives (If applicable):
na

Target Audience (If applicable):
National Medicines Regulatory Agencies; other organizations supporting PMS activities may also benefit.