E-Waste Management in East 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.

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

10.21203/rs.3.rs-35630/v3 ◽

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.

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

BMC Public Health ◽

10.1186/s12889-021-10169-1 ◽

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.

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

10.21203/rs.3.rs-35630/v5 ◽

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.

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

10.21203/rs.3.rs-35630/v4 ◽

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.

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

10.21203/rs.3.rs-35630/v2 ◽

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.

Download Full-text

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

10.21203/rs.3.rs-35630/v7 ◽

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.

Download Full-text

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

10.21203/rs.3.rs-35630/v1 ◽

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.

Download Full-text

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

10.21203/rs.3.rs-35630/v6 ◽

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.

Download Full-text