Assessing the capacity of Rwanda FDA in ensuring the quality of medicines in Rwanda.

Abstract

Background- Several studies have shown that measures put in place to ensure the quality of medicines in the health supply chains of the low and middle-income countries (LMICs) are not sufficient. National Medicines Regulatory Authorities (NMRAs) in LMICs have limited capacity to prevent and detect the supply of poor-quality medicines. Therefore, this study was designed to assess the capacity of Rwanda FDA to ensure the quality of medicines in Rwanda.

The objective- This study aimed to assess the capacity of Rwanda FDA, (the national medicine regulatory authority in Rwanda) to identify gaps and existing opportunities for improving regulatory capacity and ensuring the quality of medicines in Rwanda.

Methods-The study design and approach used is descriptive and cross-sectional. Both quantitative and qualitative approaches were used. The Quantitative research used a selfadministered questionnaire while the qualitative research approach covered a desk review of key regulatory documents including policies, laws, regulations, guidelines, procedures, reports and lists of registered products, a list of published licensed premises. The data collection tool was developed based on the World Health Organization (WHO) Global Benchmarking Tool (GBT) for “Evaluation of National Regulatory System of Medical Products Revision VI”.

Results-The findings of this study showed that among 251 sub-indicators assessed; 179 subindicators (71%) were scored as implemented, 17 sub-indicators (7%) were scored as partially implemented, 9 sub-indicators (4%) were scored as ongoing implementation while 46 sub-indicators (18%) were scored as not implemented. The findings of the present study also showed the overall sub-indicators implementation percentage of 71% (179/251). 26 (96%) out of 27 sub-indicators implemented were at maturity level 1; 27 (93%) out of 29 sub-indicators implemented were at maturity level 2; 121 (86%) out of 141 sub-indicators implemented were at maturity level 3 and 5 (9%) out of 54 sub-indicators implemented were at maturity level 4. The findings of the study showed that the estimated maturity level at which Rwanda FDA operates is maturity level 2.

Conclusions-The results showed that all key regulatory functions which are Registration and Marketing Authorization, Vigilance, Market Surveillance and Control, Licensing Establishments, Regulatory Inspection, Laboratory Testing and Clinical Trials Oversight were addressed. The legal framework was in place to enable effective and efficient implementation of the key regulatory functions. The legal framework provides adequate powers to the Rwanda FDA to ensure the quality, safety and efficacy of medicines on the market. The scope of products to be regulated is well defined. However, the implementation of key regulatory functions faced challenges that need to be addressed. Therefore, recommendations implementation to address challenges are needed by each department/division/unit of the Rwanda FDA.