Implementation Science for Effective Risk Management of Medicines: A Call for Global Action

Published 30 July 2026

Author(s): Meredith Y. Smith, Priya Bahri, Delese Mimi Darko, Alex N. O. Dodoo, Adrien Inoubli, Elaine H. Morrato, Christine Perera & Shanti Pal

Abstract

Pharmaceutical risk minimization, as an essential element of pharmacovigilance, aims to reduce medicinal product risks in order to improve a product’s benefit-risk profile. However, to date the practical application of risk minimization has proved challenging. In particular, risk minimization standards developed by and for high-income countries have been shown to have limited suitability in low and middle income countries (LMICs) and high-income countries have struggled to deliver these programs with consistently high quality and demonstrable long-term impact. The World Health Organization’s new 2025 framework for pharmacovigilance—‘The Global Smart Pharmacovigilance Strategy’—calls for developing comprehensive and sustainable safety monitoring and risk management practices as integral components of healthcare and regulatory systems in all member countries globally. The field of implementation science offers a robust set of approaches to address current gaps and challenges in risk minimization, one that can help meet the needs of twenty-first century pharmacovigilance.