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Research article
Margareth Ndomondo-Sigonda
Pharmacology Division, Department of Pharmacy and Pharmacology, Faculty of Health Sciences, University of Witwatersrand 2. African Union Development Agency -New Partnership for Africa’s Development
Corresponding Author
ORCiD: https://orcid.org/0000-0002-0395-063X
License:
This work is licensed under a CC BY 4.0 License. Read Full License
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.
Keywords
East African Community, medical products regulation, regulatory capacity, Africa regulatory harmonization, registration, regulatory inspection, efficiency, governance
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On 03 Jan, 2021
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Submission checks complete
On 16 Dec, 2020
Editorial decision: Minor revision
On 14 Dec, 2020
No comments provided
Submission checks complete
On 05 Dec, 2020
Editorial decision: Minor revision
On 03 Dec, 2020
No comments provided
Editorial decision: Minor revision
On 24 Nov, 2020
Editor assigned
On 01 Nov, 2020
Submission checks complete
On 01 Nov, 2020
Editor invited
On 01 Nov, 2020
No comments provided
Review #1 received
Received 29 Oct, 2020
Editorial decision: Minor revision
On 29 Oct, 2020
Reviewer #2 agreed
On 06 Oct, 2020
Review #2 received
Received 06 Oct, 2020
Reviewer #1 agreed
On 05 Oct, 2020
Editor assigned
On 30 Sep, 2020
Reviewers invited
Invitations sent on 30 Sep, 2020
Submission checks complete
On 29 Sep, 2020
Editor invited
On 29 Sep, 2020
Version 2
Posted 09 Sep, 2020
No comments provided
Editorial decision: Minor revision
On 15 Sep, 2020
Review #1 received
Received 07 Sep, 2020
Review #2 received
Received 07 Sep, 2020
Reviewer #2 agreed
On 06 Sep, 2020
Reviewer #1 agreed
On 05 Sep, 2020
Reviewers invited
Invitations sent on 04 Sep, 2020
Editor assigned
On 31 Aug, 2020
Submission checks complete
On 30 Aug, 2020
Editor invited
On 30 Aug, 2020
No comments provided
Editorial decision: Minor revision
On 16 Aug, 2020
Reviewer #2 agreed
On 16 Aug, 2020
Review #2 received
Received 16 Aug, 2020
Review #1 received
Received 05 Aug, 2020
Reviewers invited
Invitations sent on 04 Aug, 2020
Reviewer #1 agreed
On 04 Aug, 2020
Editor assigned
On 23 Jun, 2020
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On 22 Jun, 2020
Editor invited
On 22 Jun, 2020
First submitted
On 19 Jun, 2020
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at BMC Public Health.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Margareth Ndomondo-Sigonda
Pharmacology Division, Department of Pharmacy and Pharmacology, Faculty of Health Sciences, University of Witwatersrand 2. African Union Development Agency -New Partnership for Africa’s Development
Corresponding Author
ORCiD: https://orcid.org/0000-0002-0395-063X
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at BMC Public Health.
No community comments so far
Submission checks complete
On 06 Jan, 2021
Editorial decision: Accept
On 03 Jan, 2021
No comments provided
Submission checks complete
On 16 Dec, 2020
Editorial decision: Minor revision
On 14 Dec, 2020
No comments provided
Submission checks complete
On 05 Dec, 2020
Editorial decision: Minor revision
On 03 Dec, 2020
No comments provided
Editorial decision: Minor revision
On 24 Nov, 2020
Editor assigned
On 01 Nov, 2020
Submission checks complete
On 01 Nov, 2020
Editor invited
On 01 Nov, 2020
No comments provided
Review #1 received
Received 29 Oct, 2020
Editorial decision: Minor revision
On 29 Oct, 2020
Reviewer #2 agreed
On 06 Oct, 2020
Review #2 received
Received 06 Oct, 2020
Reviewer #1 agreed
On 05 Oct, 2020
Editor assigned
On 30 Sep, 2020
Reviewers invited
Invitations sent on 30 Sep, 2020
Submission checks complete
On 29 Sep, 2020
Editor invited
On 29 Sep, 2020
Version 2
Posted 09 Sep, 2020
No comments provided
Editorial decision: Minor revision
On 15 Sep, 2020
Review #1 received
Received 07 Sep, 2020
Review #2 received
Received 07 Sep, 2020
Reviewer #2 agreed
On 06 Sep, 2020
Reviewer #1 agreed
On 05 Sep, 2020
Reviewers invited
Invitations sent on 04 Sep, 2020
Editor assigned
On 31 Aug, 2020
Submission checks complete
On 30 Aug, 2020
Editor invited
On 30 Aug, 2020
No comments provided
Editorial decision: Minor revision
On 16 Aug, 2020
Reviewer #2 agreed
On 16 Aug, 2020
Review #2 received
Received 16 Aug, 2020
Review #1 received
Received 05 Aug, 2020
Reviewers invited
Invitations sent on 04 Aug, 2020
Reviewer #1 agreed
On 04 Aug, 2020
Editor assigned
On 23 Jun, 2020
Submission checks complete
On 22 Jun, 2020
Editor invited
On 22 Jun, 2020
First submitted
On 19 Jun, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at BMC Public Health.
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.
Figure 1
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
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