Overview
Trust in regulated medical products (medicines, vaccines and other health products)
to protect health, is mostly based on a number of principles: the evaluation before
marketing authorization, the permanent oversight of manufacturing facilities and a
permanent assessment of benefit/risk balance all through the products life cycle.
Science is at the forefront of this ecosystem, and the transparency of regulatory
procedures plays an essential role in building the much needed societal trust.
Behind every product lies a system that must safeguard not only its quality and
effectiveness but also its safety. Too often, pharmacovigilance and broader regulatory
functions are fragmented, underfunded or disconnected from the wider health
infrastructure, leaving millions – particularly in low- and middle-income countries –
exposed to avoidable risks. The COVID-19 pandemic served as a global stress test,
brutally exposing these vulnerabilities and underscoring the urgent need for resilient,
reliable, agile and responsible regulatory systems.
The present The global smart pharmacovigilance strategy was developed in response
to these challenges. It is built on a simple but powerful idea: safety systems do not
need to be complex to be effective – they need to be designed intelligently, to build
pharmacovigilance systems that are not only functional but also strategic, sustainable,
and tailored to national priorities. It is not a rigid checklist, but a practical framework to
help countries prioritize, build capacity, and embed sustainable pharmacovigilance into
regulatory systems as well as broader health systems shaped by real-world experience.
The vision is clear: to foster pharmacovigilance and regulatory systems that are strong,
adaptive and trusted – systems that guarantee equitable access to affordable, qualityassured health products for everyone everywhere. This is not only a technical priority
but also an ethical imperative, especially as disparities in access to essential health
products persist and global health challenges evolve.
From the recommendations at the 2018 International Conference of Drug Regulatory
Authorities (ICDRA) in Dublin (Ireland) up to today, successive forums have set the
sense of urgency for the proposed improvements.
The global smart pharmacovigilance strategy represents a comprehensive alignment,
moving the existing recommendations under an adaptive framework that establishes a
risk-based prioritization, meeting the need to address innovation and also to implement
reliance mechanisms, within global multilateral cooperation mechanisms.
More than an incremental change, the strategy focuses on the centrality of risk
management in a global system, building on multilateral cooperation, collectively
owned by regulators and stakeholders.
