Landscape Analysis of Existing Policies, Laws and Regulations on Antimicrobial Stewardship in 10 Low- and...

Background/Objectives: Effective antimicrobial stewardship (AMS) is vital for containing antimicrobial resistance (AMR), yet evidence regarding existing regulatory frameworks in low- and middle-income countries (LMICs) remains scarce. This study conducted a landscape analysis of policies, laws, and regulations governing AMS across human and animal health sectors in ten LMICs to identify gaps and inform national action plans. Methods: Between October 2019 and September 2022, data were collected through desk reviews of national documents and a standardized, structured questionnaire administered to key national informants in ten countries: Bangladesh, Burkina Faso, Cameroon, Côte d'Ivoire, Mali, Mozambique, Nigeria, Senegal, Tanzania, and Uganda. Results: Findings were analyzed across five core regulatory domains. While all countries maintained national medicine policies and regulatory authorities, antimicrobial-specific measures were often insufficient, particularly in the animal health sector. Human health frameworks were generally more advanced; however, overarching regulations for marketing authorization, post-marketing surveillance, and pharmacovigilance frequently lacked the necessary specificity for antimicrobials. Conclusions: Addressing these gaps requires strengthening One Health legal frameworks, particularly through targeted animal health policies and multisectoral coordination. Enhanced investments in capacity-building and systematic enforcement are essential to optimize antimicrobial use and strengthen the AMR response.