Background Access to quality medicines is a global initiative to ensure universal health coverage. However, the limited capacity of National Medicines Regulatory Authorities (NMRAs) to prevent and detect the supply of poor-quality medicines led to the predominance of sub-standard and falsified (SF) medicines in the supply chains of many countries. Therefore, this study was designed to assess the capacity of a young NMRA to ensure the quality of medicines with Rwanda as a case study. Objective This study aimed to assess the capacity of the Rwanda FDA, a young NMRA, to identify gaps and existing opportunities for improving regulatory capacity and ensuring the quality of medicines. Methods This study used a descriptive cross-sectional design with both quantitative and qualitative approaches. The quantitative approach used a self-administered questionnaire to collect data from employees of Rwanda FDA who are involved in medicine regulatory practices based on their positions while the qualitative research approach covered a desk review of key regulatory documents. The data collection tool was developed from the World Health Organization (WHO) Global Benchmarking Tool (GBT) for “Evaluation of National Regulatory System of Medical Products Revision VI”. Results Of the 251 WHO sub-indicators assessed, 179 sub-indicators (71%) were fully implemented, 17 sub-indicators (7%) were partially implemented, 9 sub-indicators (4%) were ongoing and 46 sub-indicators (18%) were not implemented by the time of the study. The results of the study showed that the estimated maturity level at which Rwanda FDA operates is maturity level 2. The study reported the challenges hindering the implementation of key regulatory functions that need to be addressed. Challenges reported include but are not limited to understaffing, lack of automation system, poor implementation of the quality management system, lack of screening technologies for SF medicines, low capacity of the quality control laboratory to test all sampled medicines and lack of regulatory inspection tools/equipment. Conclusion Findings indicated that all key regulatory functions were operating and supported by the legal framework. However, the implementation of key regulatory functions faced challenges that need to be addressed for better organizational effectiveness and compliance with the requirements of a higher maturity level.

EThe oral quinine drops were prepared -Raman and NIR spectroscopy methods were developed and validated -The methods were applied for analysis the real and substandard drugs. Poor quality antimalarial drugs are one of the public's major health problems in Africa. The 14 depth of this problem may be explained in part by the lack of effective enforcement and the 15 lack of efficient local drug analysis laboratories. To tackle part of this issue, two 16 spectroscopic methods with the ability to detect and to quantify quinine dihydrochloride in 17 children's oral drops formulations were developed and validated. Raman and Near Infrared 18 (NIR) spectroscopy were selected for the drug analysis due to their low cost, non-destructive 19 and rapid characteristics. Both of the methods developed were successfully validated using 20 the total error approach in the range of 50-150% of the target concentration (20% W/V) 21 within the 10% acceptance limits. Samples collected on the Congolese pharmaceutical market 22 were analyzed by both techniques to detect potentially substandard drugs. After a comparison 23 of the analytical performance of both methods, it has been decided to implement the method 24 based on NIR spectroscopy to perform the routine analysis of quinine oral drop samples in the 25 Quality Introduction 31Malaria remains one of the most rampant illnesses worldwide and is one of the main 32 causes of child mortality in developing countries [1][2]. The treatment of uncomplicated 33 malaria is based on conventional antimalarial drugs (e.g. chloroquine, artemisinin derivatives, 34 atovaquone, etc.). These drugs are essentially used as combinations due to the growing 35 resistance observed with single-drug therapy [3]. However, quinine is still recommended 36 alone in the treatment of severe and/or cerebral malaria attacks as well as for chloroquine-37 resistant falciparum malaria [4]. Four quinine based dosage forms are found on the 38 pharmaceutical market in DRC: tablets (250 and 500 mg), ampuls (250 and 500 mg/2mL), 39 syrup (100 mg /mL) and oral drops (200 mg /mL). The last three dosage forms are the most 40 used with 0-5 year old children. In 2009, the Health Ministry of the DRC warned citizens 41 against quinine oral drops "Quinizen 20%" that were found to have been counterfeit and 42 substandard [5]. 43Poor quality (substandard, counterfeit and degraded) or substandard/spurious/falsely-44 labelled/falsified/counterfeit anti-malarial drugs constitute a major public health concern 45 especially in developing countries where the pharmaceutical market is poorly regulated and 46The use such drugs may lead to therapeutic failure, death and reinforce drug resistance [7, 8]. t vVibrational spectroscopic techniques, such as Near Infrared (NIR) and Raman 49 spectroscopies are frequently used techniques in the field of quantitative drug analysis [9-11] 50 and in the fight against counterfeit drugs [12][13][14][15]. These techniques have the advantages of 51 being non-destructive, fast, requiring little or no sample...

Liquid chromatographic methods in isocratic mode for the analysis of poor quality medicines are privileged due to their simplicity and facility in methods development. They are generally fast; do not need to be re-equilibrated between sample injections; have larger flexibility with acceptable changes on different column dimensions; and are applicable to LC systems equipped with simple or high developed pumps. In this study, we focused on developing simple isocratic methods using classical mobile phase composed by methanol and ammonium formate buffer for the analysis of most common antimalarial medicines marketed in malaria endemic countries and susceptible of being counterfeit/falsified, substandard and degraded. The selected medicines were quinine and related cinchona alkaloids in tablets and injectable forms; artemether/lumefantrine tablets; and artemisinin compounds (arteether, artemether, and artesunate) in injectable forms. The current methods were developed thanks to simple methodological approach consisting in sequential isocratic runs through adjustment or adaptation of existing methods to obtain optimal analytical conditions without complex design of experiments that might be long and costly. Then, the new methods presented shorter analysis time; allowed increase of sample analysis throughput; and obviously consumed little mobile phase solvents on classical analytical columns: 50-250 mm of length (L), 4.6 mm of internal diameter (I.D.), and 3.5-5.0 µm of particle size (dp).

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