WHO: The Global Smart Pharmacovigilance Strategy (7 November 2025)

Summary

The World Health Organization’s Global Smart Pharmacovigilance Strategy seeks guides countries in building and strengthening pharmacovigilance systems (activities related to detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems). It is intended as a reference document for national regulatory agencies, expanded programmes on immunization and pharmacovigilance partners in countries.

Content

This report sets out:

• How to implement the Global Smart Pharmacovigilance Strategy.
• How to approach measuring the uptake and impact of the Strategy.
• Examples of the application of its principles to case studies from Brazil, Egypt, Ethiopia, Indonesia and Japan.

The strategy focuses on four aspects that countries need to consider when building or strengthening their pharmacovigilance systems:

1. Previous efforts, lessons learnt and existing pharmacovigilance resources - pharmacovigilance has advanced significantly since the launch of the WHO Programme for International Drug Monitoring in 1968. It encourages building on this achievements.
2. Risk-based approach and prioritisation - in the context of limited resources, countries are encouraged to prioritize their pharmacovigilance efforts by focusing on: products of specific relevance to their settings (e.g. medicines for endemic conditions); safety data that are unlikely to be generated elsewhere; and active participation in global pharmacovigilance efforts for new products introduced simultaneously across high-, middle-, and low-income countries.
3. Work-sharing and reliance – encouraging countries to prioritise pharmacovigilance activities based on their available resources and regulatory capacity, and to tailor development plans accordingly. The principles of work-sharing and reliance are central to enabling this flexible, context-specific approach.
4. Anchoring pharmacovigilance in the overall regulatory system-strengthening efforts - for PV to be sustainable, the Strategy it must be integrated into the overall regulatory framework.