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The capacity of young national medicine regulatory authorities to ensure the quality of medicines: case of Rwanda

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)...

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Autores principales: Shabani, Jean Baptiste B., Kayitare, Egide, Nyirimigabo, Eric, Habyalimana, Vedaste, Murindahabi, Marilyn M., Ntirenganya, Lazare, Irasabwa, Clarisse, Rutungwa, Eugene, Munyangaju, Jose Edouard, Hahirwa, Innocent
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9700871/
https://www.ncbi.nlm.nih.gov/pubmed/36434730
http://dx.doi.org/10.1186/s40545-022-00492-2
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author Shabani, Jean Baptiste B.
Kayitare, Egide
Nyirimigabo, Eric
Habyalimana, Vedaste
Murindahabi, Marilyn M.
Ntirenganya, Lazare
Irasabwa, Clarisse
Rutungwa, Eugene
Munyangaju, Jose Edouard
Hahirwa, Innocent
author_facet Shabani, Jean Baptiste B.
Kayitare, Egide
Nyirimigabo, Eric
Habyalimana, Vedaste
Murindahabi, Marilyn M.
Ntirenganya, Lazare
Irasabwa, Clarisse
Rutungwa, Eugene
Munyangaju, Jose Edouard
Hahirwa, Innocent
author_sort Shabani, Jean Baptiste B.
collection PubMed
description 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.
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spelling pubmed-97008712022-11-27 The capacity of young national medicine regulatory authorities to ensure the quality of medicines: case of Rwanda Shabani, Jean Baptiste B. Kayitare, Egide Nyirimigabo, Eric Habyalimana, Vedaste Murindahabi, Marilyn M. Ntirenganya, Lazare Irasabwa, Clarisse Rutungwa, Eugene Munyangaju, Jose Edouard Hahirwa, Innocent J Pharm Policy Pract Research 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. BioMed Central 2022-11-24 /pmc/articles/PMC9700871/ /pubmed/36434730 http://dx.doi.org/10.1186/s40545-022-00492-2 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Shabani, Jean Baptiste B.
Kayitare, Egide
Nyirimigabo, Eric
Habyalimana, Vedaste
Murindahabi, Marilyn M.
Ntirenganya, Lazare
Irasabwa, Clarisse
Rutungwa, Eugene
Munyangaju, Jose Edouard
Hahirwa, Innocent
The capacity of young national medicine regulatory authorities to ensure the quality of medicines: case of Rwanda
title The capacity of young national medicine regulatory authorities to ensure the quality of medicines: case of Rwanda
title_full The capacity of young national medicine regulatory authorities to ensure the quality of medicines: case of Rwanda
title_fullStr The capacity of young national medicine regulatory authorities to ensure the quality of medicines: case of Rwanda
title_full_unstemmed The capacity of young national medicine regulatory authorities to ensure the quality of medicines: case of Rwanda
title_short The capacity of young national medicine regulatory authorities to ensure the quality of medicines: case of Rwanda
title_sort capacity of young national medicine regulatory authorities to ensure the quality of medicines: case of rwanda
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9700871/
https://www.ncbi.nlm.nih.gov/pubmed/36434730
http://dx.doi.org/10.1186/s40545-022-00492-2
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