EB158.R5
EB158
EB158.R5
Advancing smart, efficient pharmacovigilance as an essential tool for robust, sustainable, resilient and responsive health systems, for everyone, everywhere1
The Executive Board,
Having considered the reports by the Director-General on universal health coverage,
RECOMMENDS to the Seventy-ninth World Health Assembly the adoption of the following resolution:
(Fourth meeting, 3 February 2026)
The Seventy-ninth World Health Assembly,
Having considered the report by the Director-General on universal health coverage;
Recalling resolution WHA16.36 (1963) urging the systematic reporting of serious adverse drug reactions and the establishment of international drug safety monitoring, including the WHO Programme for International Drug Monitoring and the designation of the Uppsala Monitoring Centre as the WHO Collaborating Centre for International Drug Monitoring;
Noting resolutions WHA60.20 (2007), WHA61.21 (2008), WHA62.16 (2009), WHA63.12 (2010), WHA65.17 (2012), WHA65.19 (2012), WHA66.22 (2013), WHA67.20 (2014), WHA67.21 (2014), WHA67.22 (2014), WHA68.7 (2015), WHA71.8 (2018) and WHA72.8 (2019), all of which encompass aspects of the need to promote access to quality, safe, effective and affordable medicines and other health technologies2 as appropriate;
Recalling resolution WHA73.1 (2020) on a comprehensive and coordinated response to the coronavirus disease (COVID-19) pandemic, which calls for intensified international cooperation and solidarity to contain, mitigate and overcome the pandemic and its consequences through responses that are people-centred and address gender inequalities;
Reaffirming the commitment to Sustainable Development Goal 3.8 to achieve universal health coverage, including access to safe, effective, quality and affordable essential medicines and vaccines for all;
Acknowledging the lessons from the coronavirus disease (COVID-19) pandemic and other public health emergencies, which highlighted the essential role of functional pharmacovigilance systems for the rapid detection and management of safety signals associated with novel health products, including vaccines and medical devices, and, equally, of timely, transparent and accurate risk communication as a way to inform the public, support informed decision-making and reinforce confidence in public health interventions;
Recognizing that pharmacovigilance data suggest distinct safety profiles across sexes and ages, where differences in reporting, outcomes and vulnerability to adverse events may exist;
Recognizing also that despite global progress, significant inequities persist in pharmacovigilance capacity, with many developing countries facing capacity and resource constraints and contributing a disproportionately small share of global safety data, resulting in populations being unequally protected against adverse events and limiting the quality and completeness of global safety data;
Acknowledging the emergence of a multitude of parallel safety monitoring systems in countries across various disease treatment programmes that often operate in silos, and may lead to inefficient use of resources and scattered data;
Recognizing the critical role of national and regional regulatory authorities and global institutions, their collaboration, the need for comprehensive and integrated pharmacovigilance systems that enable robust, timely evidence-based, benefit-risk assessment of medicines and other health technologies;
Recognizing also that collaboration between national and regional authorities and global institutions is also key to addressing capacity-building gaps;
Recognizing further that good vigilance practices, including in local production, are essential to foster access to safe, effective and quality assured medicines and other health technologies in a country;
Noting the transformative potential of digital technologies, real-world data and artificial intelligence to enhance safety surveillance, signal detection and regulatory decision‑making;
Stressing that smart, risk-based, integrated and collaborative pharmacovigilance strategies can maximize the impact of limited public health resources, enhance the timeliness of safety signal detection, avoid duplication, and foster reliance and work-sharing and harmonized decision-making among Member States and regions;
Acknowledging that misinformation and disinformation about the safety of medicines, vaccines and medical devices, and more broadly about science, can seriously undermine public confidence and trust in these life-saving products and public health programmes and cause harm;
Affirming that strengthening pharmacovigilance contributes to public trust in health systems and immunization programmes,7,8 improves patient safety and is an essential component for achievement of the goals of universal health coverage and preparedness for future health emergencies, including the uptake and impact of norms and standards on smart pharmacovigilance;
additionally, it has a significant economic impact, as it optimizes resource allocation and reduces the broader costs associated with adverse events;
Noting that Member States continue to access and benefit from all the resources and services that are already offered by WHO through the Uppsala Monitoring Centre as the WHO Collaborating Centre for International Drug Monitoring,
1.
(1)
to drive the integration of vigilance systems in order to optimize the use of vigilance data and evidence, for a more comprehensive regulation of medicines and other health technologies and patient care;
(2)
to strengthen national pharmacovigilance systems including patient/consumer reporting systems so that patients and caregivers can easily report adverse events to health authorities/institutions and to support education and awareness efforts on how to identify and report such events;
(3)
to strengthen and modernize national pharmacovigilance systems as an integral part of regulatory systems where applicable, including where appropriate through adequate governance, domestic and international financing, and human resource capacity (in addition to the resources that are provided by WHO to Member States, free of cost, through the Uppsala Monitoring Centre);
(4)
to consider or strengthen the application of safety and vigilance principles beyond medicines and vaccines to include other relevant health products;
(5)
to adopt evidence-based, smart and effective approaches to pharmacovigilance, addressing the most significant risks and prioritizing high-impact activities and products, and to participate where appropriate in regional or global work and reliance mechanisms to optimize resource use;
(6)
to develop or strengthen relevant legal and regulatory frameworks, guidelines and manuals to support, where appropriate, good pharmacovigilance practices as an essential responsibility of manufacturers, including in local production, for quality assured essential medicines;
(7)
to leverage real-world data, digital platforms and innovative tools, including artificial intelligence and machine learning, in a safe, transparent and ethical manner to improve safety signal detection and response, while also maintaining public trust;
(8)
to promote the integration of sex- and age-related safety considerations throughout the development, regulation and use of medicines and to strengthen pharmacovigilance systems that routinely collect, analyse and use sex- and age‑disaggregated data on adverse events for diverse population groups;
(9)
to integrate pharmacovigilance within relevant strategies that advance universal health coverage, ensuring patient safety monitoring across all levels of care;
(10)
to integrate pharmacovigilance training in teaching institutions and strengthen regulatory capacity-building and workforce training in pharmacovigilance;
(11)
to collaborate with local, regional and global stakeholders, including public health programmes, academic institutions, the private sector where appropriate, and patients' organizations, to strengthen pharmacovigilance and knowledge sharing;
(12)
to establish or further utilize, where appropriate, pharmacovigilance coordination platforms with partners and stakeholders at the national, regional and global levels for resource optimization and timely decision-making;
2.
REQUESTS the Director-General:
(1)
to continue to update the existing or, if necessary, to develop global normative guidance and technical tools in consultation with Member States to support “smart pharmacovigilance”, taking into consideration real world evidence and the ethical use of artificial intelligence for pharmacovigilance purposes and align with existing initiatives in this area;
(2)
to consolidate performance metrics for pharmacovigilance systems and provide technical support to Member States, upon their request, in assessing and improving their pharmacovigilance systems, including the uptake and impact of norms and standards on smart pharmacovigilance;
(3)
to continue enhancing international collaboration and information sharing, reliance and work-sharing for effective pharmacovigilance among Member States and regions, and continue to take measures to strengthen health literacy on pharmacovigilance to counter disinformation and misinformation, including by facilitating access to evidence-based and science-based information;
(4)
to support data quality, interoperability and equitable participation of all Member States including developing countries, building on global databases10 while respecting data sovereignty and data security;
(5)
to promote capacity development through training programmes for workers in the healthcare and related sectors, including knowledge exchange, and the dissemination of best practices in pharmacovigilance system design and operation;
(6)
to report back to the Eighty-first, Eighty-third and Eighty-fifth World Health Assemblies in 2028, 2030 and 2032, respectively, on progress in implementing this resolution and on the state of global pharmacovigilance systems, including their contribution to universal health coverage and health emergency preparedness.
See ANNEX 5 for the financial and administrative implications for the Secretariat of this resolution.
Medicines and other health technologies includes pharmaceuticals, vaccines, biopharmaceuticals and medical devices.
Watson S, Caster O, Rochon PA, den Ruijter H. Reported adverse drug reactions in women and men: aggregated evidence from globally collected individual case reports during half a century. eClinicalmedicine.
2019 Dec;17:100188. doi: 10.1016/j.eclinm.2019.10.001.
Aurich B, Apele-Freimane D, Banaschewski T, Chouchana L, Day S, Kaguelidou F, et al. c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children – A c4c expert group white paper. British Journal of Clinical Pharmacology. 2021 Oct 26;88(12):4997-5016. doi: 10.1111/bcp.15119.
VigiBase data access conditions. Geneva: World Health Organization; 2025. (accessed 29 January 2026).
VigiAccess: frequently asked questions. Geneva: World Health Organization; 2026. (accessed 29 January 2026).
Iessa N, Sarinic VM, Ghazaryan L, Romanova N, Alemu A, Rungapiromnan W, et al. Smart Safety Surveillance (3S): Multi-Country Experience of Implementing the 3S Concepts and Principles. Drug Safety. 2021 Oct;44(10):1085–98. doi: 10.1007/s40264-021-01100-z.
Unmasking safety signals during a pandemic. Technical meeting report. Geneva: World Health Organization; 2022 (accessed 29 January 2026).
And, where applicable, regional economic integration organizations.
The global medicines safety database (accessed 30 January 2026).
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