Evidence map›Paper›PMID 33478421›Full record

ArticleBMC public health2021

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

Margareth Ndomondo-Sigonda, Jacqueline Miot, Shan Naidoo, Nelson E Masota, Brian Ng'andu, Nancy Ngum, Eliangiringa Kaale

Abstract read
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In one paragraph

Article in BMC public health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Margareth Ndomondo-SigondaPharmacology Division, Department of Pharmacy and Pharmacology, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa. 766425@students.wits.ac.za.ORCID 0000-0002-0395-063X
Jacqueline MiotHealth Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.
Shan NaidooPublic Health Medicine Department, School of Public Health, University of Witwatersrand, Johannesburg, South Africa.
Nelson E MasotaInstitute for Pharmacy and Food Chemistry, University of Wuerzburg, Wuerzburg, Germany.
Brian Ng'anduAfrican Union Development Agency -New Partnership for Africa's Development (AUDA-NEPAD), Midrand, South Africa.
Nancy NgumAfrican Union Development Agency -New Partnership for Africa's Development (AUDA-NEPAD), Midrand, South Africa.
Eliangiringa KaaleSchool of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLimited 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.

methodsAn 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.

resultsPolicy 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.

conclusionsThe 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.

Indexed as

Health ServicesLegislation, DrugGovernment AgenciesHumansAfrica regulatory harmonizationEast African communityEfficiencyGovernanceMedical products regulationRegistrationRegulatory capacityRegulatory inspection

Identifiers

PMID33478421
PMCPMC7818747

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.