scholarly journals Harmonization of medical products regulation: A key factor for improving regulatory capacity in the East African Community

2020 ◽  
Author(s):  
Margareth Ndomondo-Sigonda ◽  
Jacqueline Miot ◽  
Shan Naidoo ◽  
Nelson Enos Masota ◽  
Brian Ng'andu ◽  
...  
Keyword(s):  
Public Health ◽  
Monitoring And Evaluation ◽  
Good Manufacturing Practice ◽  
Structured Interviews ◽  
East African ◽  
East African Community ◽  
Medical Products ◽  
Inspection Systems ◽  
African Community ◽  
Regulatory Harmonization

Abstract Background: Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies, with a focus on registration and inspection systems. Methods: An exploratory mixed-method design using both qualitative and quantitative data, was employed. Data was collected from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat through a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11-2015/16 whereas 2010/11 data served as baseline. Interviews were conducted with heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer. A set of 14 indicators grouped into 6 categories were used to measure NMRAs performance. Results: Policy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites, reliance and cooperation are key factors for building trust and capacity among NMRAs. Five out of six of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with four NMRAs attaining ISO 9001:2015 certification.Conclusions: The EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.

scholarly journals Harmonization of medical products regulation: a key factor for improving regulatory capacity in the East African Community

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Margareth Ndomondo-Sigonda ◽  
Jacqueline Miot ◽  
Shan Naidoo ◽  
Nelson E. Masota ◽  
Brian Ng’andu ◽  
...  
Keyword(s):  
Public Health ◽  
Monitoring And Evaluation ◽  
Good Manufacturing Practice ◽  
Structured Interviews ◽  
East African ◽  
East African Community ◽  
Medical Products ◽  
Inspection Systems ◽  
African Community ◽  
Regulatory Harmonization

Abstract Background Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies, with a focus on registration and inspection systems. Methods An exploratory mixed-method design using both qualitative and quantitative data to access data from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat. Data was collected using a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11–2015/16 with 2010/11 data serving as baseline. Heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer were enrolled in the study. A set of 14 indicators grouped into 6 categories were used to assess NMRAs performance. Results Policy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites, reliance and cooperation are key factors for building trust and capacity among NMRAs. Five out of six of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with four NMRAs attaining ISO 9001:2015 certification. Conclusions The EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.

scholarly journals Harmonization of medical products regulation: A key factor for improving regulatory capacity in the East African Community

2020 ◽  
Author(s):  
Margareth Ndomondo-Sigonda ◽  
Jacqueline Miot ◽  
Shan Naidoo ◽  
Nelson Enos Masota ◽  
Brian Ng'andu ◽  
...  
Keyword(s):  
Public Health ◽  
Monitoring And Evaluation ◽  
Good Manufacturing Practice ◽  
Structured Interviews ◽  
East African ◽  
East African Community ◽  
Medical Products ◽  
Inspection Systems ◽  
African Community ◽  
Regulatory Harmonization

Abstract Background: Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies, with a focus on registration and inspection systems. Methods: An exploratory mixed-method design using both qualitative and quantitative data to access data from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat. Data was collected using a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11-2015/16 with 2010/11 data serving as baseline. Heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer were enrolled in the study. A set of 14 indicators grouped into 6 categories were used to assess NMRAs performance. Results: Policy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites, reliance and cooperation are key factors for building trust and capacity among NMRAs. Five out of six of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with four NMRAs attaining ISO 9001:2015 certification.Conclusions: The EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.

scholarly journals Harmonization of medical products regulation: A key factor for improving regulatory capacity in the East African Community

2020 ◽  
Author(s):  
Margareth Ndomondo-Sigonda ◽  
Jacqueline Miot ◽  
Shan Naidoo ◽  
Nelson Enos Masota ◽  
Brian Ng'andu ◽  
...  
Keyword(s):  
Public Health ◽  
Monitoring And Evaluation ◽  
Good Manufacturing Practice ◽  
Structured Interviews ◽  
East African ◽  
East African Community ◽  
Medical Products ◽  
Inspection Systems ◽  
African Community ◽  
Regulatory Harmonization

Abstract AbstractBackground: Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies, with a focus on registration and inspection systems. Methods: An exploratory mixed-method design using both qualitative and quantitative data was employed. Data was collected from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat through a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11-2015/16 whereas 2010/11 data served as baseline. Interviews were conducted with heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer. A set of 14 indicators grouped into 6 categories were used to measure NMRAs performance. Results: Policy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites, reliance and cooperation are key factors for building trust and capacity among NMRAs. Five out of six of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with four NMRAs attaining ISO 9001:2015 certification.Conclusions: The EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.

scholarly journals Harmonization of medical products regulation: A key factor for improving regulatory capacity in the East African Community

2020 ◽  
Author(s):  
Margareth Ndomondo-Sigonda ◽  
Jacqueline Miot ◽  
Shan Naidoo ◽  
Nelson Masota ◽  
Brian Ng'andu ◽  
...  
Keyword(s):  
Public Health ◽  
Monitoring And Evaluation ◽  
Good Manufacturing Practice ◽  
Structured Interviews ◽  
East African ◽  
East African Community ◽  
Medical Products ◽  
Inspection Systems ◽  
African Community ◽  
Regulatory Harmonization

Abstract Background: Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies with focus on registration and inspection systems as part of the African Union medicines regulatory harmonization initiative. Methods: An exploratory mixed-method design using both qualitative and quantitative data, was employed. Data was collected from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat through a combination of semi-structured interviews, questionnaires, and checklists for the period 2011/12-2014/15 while 2010/11 data served as baseline. Interviews were conducted with heads of NMRAs; regulatory and monitoring and evaluation experts; and the EAC Secretariat Project Officer. A set of 29 indicators grouped into 9 categories were used to measure NMRAs performance. Results: policy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites; reliance and cooperation are key factors for building trust and capacity among NMRAs. 83.3% of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with 80% attaining ISO 9001:2015 certification. Efficiency of registration processes improved by 66.6%. Conclusions: The EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.

scholarly journals Harmonization of medical products regulation: A key factor for improving regulatory capacity in the East African Community

2021 ◽  
Author(s):  
Margareth Ndomondo-Sigonda ◽  
Jacqueline Miot ◽  
Shan Naidoo ◽  
Nelson Enos Masota ◽  
Brian Ng'andu ◽  
...  
Keyword(s):  
Public Health ◽  
Monitoring And Evaluation ◽  
Good Manufacturing Practice ◽  
Structured Interviews ◽  
East African ◽  
East African Community ◽  
Medical Products ◽  
Inspection Systems ◽  
African Community ◽  
Regulatory Harmonization

Abstract Background: Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies, with a focus on registration and inspection systems. Methods: An exploratory mixed-method design using both qualitative and quantitative data to access data from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat. Data was collected using a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11-2015/16 with 2010/11 data serving as baseline. Heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer were enrolled in the study. A set of 14 indicators grouped into 6 categories were used to assess NMRAs performance. Results: Policy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites, reliance and cooperation are key factors for building trust and capacity among NMRAs. Five out of six of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with four NMRAs attaining ISO 9001:2015 certification.Conclusions: The EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.

scholarly journals Harmonization of medical products regulation: A key factor for improving regulatory capacity in the East African Community

2020 ◽  
Author(s):  
Margareth Ndomondo-Sigonda ◽  
Jacqueline Miot ◽  
Shan Naidoo ◽  
Nelson Masota ◽  
Brian Ng'andu ◽  
...  
Keyword(s):  
Public Health ◽  
Monitoring And Evaluation ◽  
Good Manufacturing Practice ◽  
Structured Interviews ◽  
East African ◽  
East African Community ◽  
Medical Products ◽  
Inspection Systems ◽  
African Community ◽  
Regulatory Harmonization

Abstract Background: Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies with focus on registration and inspection systems as part of the African Union medicines regulatory harmonization initiative. Methods: An exploratory mixed-method design using both qualitative and quantitative data, was employed. Data was collected from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat through a combination of semi-structured interviews, questionnaires, and checklists for the period 2011/12-2014/15 while 2010/11 data served as baseline. Interviews were conducted with heads of NMRAs; regulatory and monitoring and evaluation experts; and the EAC Secretariat Project Officer. A set of 29 indicators grouped into 9 categories were used to measure NMRAs performance. Results: policy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites; reliance and cooperation are key factors for building trust and capacity among NMRAs. 83.3% of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with 80% attaining ISO 9001:2015 certification. Efficiency of registration processes improved by 66.6%. Conclusions: The EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.

scholarly journals Harmonization of medical products regulation: A key factor for improving regulatory capacity in the East African Community

2020 ◽  
Author(s):  
Margareth Ndomondo-Sigonda ◽  
Jacqueline Miot ◽  
Shan Naidoo ◽  
Nelson Enos Masota ◽  
Brian Ng'andu ◽  
...  
Keyword(s):  
Public Health ◽  
Monitoring And Evaluation ◽  
Good Manufacturing Practice ◽  
Structured Interviews ◽  
East African ◽  
East African Community ◽  
Medical Products ◽  
Inspection Systems ◽  
African Community ◽  
Regulatory Harmonization

Abstract Background: Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies, with a focus on registration and inspection systems. Methods: An exploratory mixed-method design using both qualitative and quantitative data to access data from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat. Data was collected using a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11-2015/16 with 2010/11 data serving as baseline. Heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer were enrolled in the study. A set of 14 indicators grouped into 6 categories were used to assess NMRAs performance. Results: Policy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites, reliance and cooperation are key factors for building trust and capacity among NMRAs. Five out of six of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with four NMRAs attaining ISO 9001:2015 certification.Conclusions: The EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.

scholarly journals E-Waste Management in East African Community

2012 ◽  
pp. 307-327 ◽  
Author(s):  
Edgar Napoleon Asiimwe ◽  
Grönlund Åke
Keyword(s):  
Adverse Effects ◽  
Waste Management ◽  
Negative Impact ◽  
Information And Communications Technologies ◽  
Structured Interviews ◽  
East African ◽  
East African Community ◽  
Fast Pace ◽  
High Government ◽  
African Community

The rapidly increased use of Information and Communications Technologies (ICTs) has increased demand for electronic equipment such as mobile phones and computers. Individuals and government institutions worldwide are adopting ICTs at a fast pace. Increased consumption has resulted in huge amounts of e-Waste generated from scrapped electronics. E-Waste contains chemical substances that have adverse effects on the environment and human health. Consequently, handling of e-Waste needs to be organized in ways that minimize the adverse effects. This chapter investigates how the East African Community (EAC) governments, i.e., Kenya, Uganda, Tanzania, Rwanda, and Burundi, conceive their role in combating negative impact of e-Waste and how their views and current actions compare to the current state of the art practices in e-Waste management. As data on e-Waste handling in EAC countries is not publicly available, semi-structured interviews with high government officials and a literature review were conducted. The results show that EAC governments consider e-Waste to be an emerging problem. Despite this awareness and attempts to mitigate the problem in some of the countries, there are currently no solid solutions that have been crafted to rectify or mitigate this problem. The study suggests practical solutions for resolving e-Waste challenges in EAC.

scholarly journals Improving access to quality medicines in East Africa: An independent perspective on the East African Community Medicines Regulatory Harmonization initiative

PLoS Medicine ◽  
2020 ◽  
Vol 17 (8) ◽  
pp. e1003092
Author(s):  
Alexander R. Giaquinto ◽  
Alberto Grignolo ◽  
Lawrence Liberti ◽  
John C. W. Lim ◽  
Tomas Salmonson ◽  
...  
Keyword(s):  
East Africa ◽  
East African ◽  
East African Community ◽  
African Community ◽  
Regulatory Harmonization

scholarly journals Commentary: mobile laboratories for SARS-CoV-2 diagnostics: what Europe could learn from the East African Community to assure trade in times of border closures

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Florian Gehre ◽  
Hakim Lagu ◽  
Emmanuel Achol ◽  
Michael Katende ◽  
Jürgen May ◽  
...  
Keyword(s):  
Public Health ◽  
East Africa ◽  
Economic Losses ◽  
Main Body ◽  
Mobile Laboratory ◽  
East African ◽  
East African Community ◽  
Laboratory Network ◽  
National Public Health ◽  
African Community

Abstract Background The emergence of SARS-CoV-2 mutants might lead to European border closures, which impact on trade and result in serious economic losses. In April 2020, similar border closures were observed during the first SARS-CoV-2 wave in East Africa. Main body Since 2017 the East African Community EAC together with the Bernhard-Nocht-Institute for Tropical Medicine BNITM established a mobile laboratory network integrated into the National Public Health Laboratories of the six Partner States for molecular diagnosis of viral haemorrhagic fevers and SARS-CoV-2. Since May 2020, the National Public Health Laboratories of Kenya, Rwanda, Burundi, Uganda and South Sudan deployed these mobile laboratories to their respective borders, issuing a newly developed “Electronic EAC COVID-19 Digital Certificate” to SARS-CoV-2 PCR-negative truck drivers, thus assuring regional trade. Conclusion Considering the large financial damages of border closures, such a mobile laboratory network as demonstrated in East Africa is cost-effective, easy to implement and feasible. The East African Community mobile laboratory network could serve as a blueprint for Europe and other countries around the globe.

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