World Health Organization (WHO) Guidelines
The WHO provides global guidelines on pharmacovigilance, particularly for countries with developing regulatory frameworks.
- WHO Guidelines on Safety Monitoring of Medicinal Products
- Focuses on building and maintaining effective national pharmacovigilance systems, particularly in low- and middle-income countries.
- Emphasizes the importance of spontaneous reporting systems, signal detection, and international collaboration through the WHO’s Programme for International Drug Monitoring.
- WHO Pharmacovigilance Indicators
- Provides a set of indicators to assess the performance of national pharmacovigilance systems.
- Helps countries monitor and improve their pharmacovigilance practices to align with global standards.
Conclusion
These key regulatory pharmacovigilance guidelines establish the standards for monitoring and managing drug safety across different stages of a product's lifecycle. By adhering to these guidelines, pharmaceutical companies, healthcare professionals, and regulatory authorities can ensure the safe and effective use of medicines, ultimately protecting public health. These guidelines also foster international collaboration and harmonization, enabling more effective global pharmacovigilance efforts.
