Supporting Rwanda FDA to Strengthen its Regulatory Services

The Rwanda FDA, established in 2018, has been working towards improving its regulatory capacity since its inception. To achieve maturity level 3 (i.e., a stable, well-functioning, integrated regulatory system), as defined by the World Health Organization (WHO) Global Benchmarking Tool (GBT), the Rwanda FDA needed to establish a quality management system (QMS). When MTaPS started working in Rwanda, in 2019, it began supporting Rwanda FDA’s QMS establishment and implementation through providing technical assistance, building capacity, raising awareness on QMS, and supporting Rwanda FDA’s internal audits. This technical brief describes MTaPS’ achievements in supporting Rwanda FDA to complete all steps under Phase 1 of QMS implementation, paving the way for stronger regulation and medicines registration in-country.