How effectively are regulatory authorities in Latin America implementing regulatory reliance in practice? This report presents findings from the first phase of a CIRS research project, showing that reliance is well established across the region but varies in how consistently it is operationalised, monitored and evaluated.

Introduction

The WHO Good Reliance Practices (Annex 10) provide essential principles and considerations for regulatory reliance implementation. However, it is not clear how well agencies have been incorporating these principles into their reliance mechanisms. To enable continuous improvement and alignment with good practice, a mechanism for systematic monitoring of reliance pathways is needed.

A CIRS research study initially focused on Latin America is assessing the extent to which current reliance practices reflect good practice, as stated by WHO Annex 10. The study covers 10 regulatory authorities and five key regulatory functions, with the objective of understanding not only whether reliance frameworks and pathways are in place, but also how reliance is being operationalised in practice, the factors that enable or constrain its use, and opportunities to strengthen implementation across the region.

Study objectives

  • Assess the implementation of reliance in 10 selected countries in Latin America
  • Identify barriers and enablers for effective implementation of reliance
  • Identify areas for improvement and alignment compared to Good Reliance Practices
  • Foster collaboration and knowledge exchange within the region to build capacity, enhance regulatory efficiency and support continuous improvement.

First phase – New marketing authorisations

The first phase of the study focused specifically on new marketing authorisations and combined desk-based research with insights from the participating regulatory authorities.

The report for the first phase is now available. Overall, the findings show that reliance is well established across Latin America, but that there remains variability in how consistently it is operationalised, monitored and evaluated.

Next steps

The next phases of the study will progressively extend the assessment to the other four regulatory functions: GMP inspections, biological and vaccine batch release, clinical trial/protocol approvals, and post-approval changes. The intention is to apply the established framework while considering targeted refinements where needed to capture function-specific aspects of reliance implementation.

This study represents a significant step toward systematic global reliance assessment, identifying current practices, barriers, and enablers for improvement whilst determining alignment with WHO Good Reliance Practices. There is interest to expand this study globally, which would enhance understanding of effective reliance implementation and support evidence-based improvements in regulatory cooperation worldwide.