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

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.