WHO “SMART” pharmacovigilance strategy
The Committees were briefed on the WHO “Smart” Pharmacovigilance Strategy, which provides guidance to countries in developing robust pharmacovigilance systems. The strategy helps regulators and immunization programmes to prioritize limited resources through work-sharing, reliance, and collaboration with other countries and building national competence for activities that cannot be delegated.
WHO launched the Smart Safety Surveillance (3S) concepts in 2017 to guide countries with limited resources in building pharmacovigilance systems. The Global Smart Pharmacovigilance Strategy builds on prior work done between WHO and countries to apply the 3S concepts and their application by the African Union during the coronavirus disease 2019 (COVID-19) pandemic. Its aim is to develop sustainable pharmacovigilance systems in all Member States through 4 principles: 1) leveraging previous efforts, infrastructure and lessons learnt; 2) adopting a risk-based approach and prioritization; 3) work-sharing and reliance; and 4) strengthening regulatory systems.
The Committees strongly supported the new WHO pharmacovigilance strategy, which builds on existing infrastructure, experience and global work during past decades. The aim of the approach is to develop sustainable pharmacovigilance systems as part of broader regulatory strengthening.
The Committees were also updated on the revised WHO–International Society of Pharmacovigilance (ISoP) pharmacovigilance curriculum, which can be used to plan and conduct training courses in pharmacovigilance. The Committees supported the plan to extend the programme. The training curriculum will be extensive. It should provide potential trainees with guidance on the target audiences of specific training modules and prerequisites for specific modules where appropriate. Additional modules, such as on immunology and falsified and substandard medicines, were suggested.