Margareth Ndomondo Sigonda

Margareth Ndomondo Sigonda
University of the Witwatersrand | wits · Department of Pharmacy and Pharmacology

About

31
Publications
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Introduction
Margareth Ndomondo Sigonda currently a PhD student at the Department of Pharmacy and Pharmacology, University of the Witwatersrand. Margareth does research in Public Health, pharmacutical manufacturing and medical products regulation. The current project is 'medicines regulation in Africa'.

Publications

Publications (31)
Article
Full-text available
Background: For almost a decade, the East African Community has implemented the Medicines Regulatory Harmonization (EAC-MRH) programme among its member states to harmonise technical requirements and standards for medical products regulation, jointly conduct scientific review of medical product dossiers to assess safety, efficacy and quality, inspec...
Article
Sub-Saharan Africa, which has a population of more than 1 billion people, carries 24% of the global burden of disease and spends the least on health care of any region, relying heavily on international development assistance to deliver health care for HIV, tuberculosis, and malaria. The demographic and epidemiological transitions occurring in sub-S...
Article
Full-text available
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 capacit...
Article
Full-text available
Background: Access to quality-assured, safe and efficacious medical products is fundamental for Universal Health Coverage and attaining Sustainable Development Goal 3: Ensure Healthy Lives and Well-being for All. To guarantee this right, there is a need for robust and efficiently performing national regulatory systems for the regulation of medical...
Article
Full-text available
Substandard and/or falsified medical products may result in treatment failure and/or death. The capacity to regulate medical products is key for ensuring the quality, safety, and efficacy of medical products circulating in a market. The experience of the East African Community, during its piloting of the Medicines Regulatory Harmonization initiativ...
Article
Full-text available
Access to essential medicines is a key pillar of any health system seeking to deliver universal health coverage. Science-based, independent regulation of medical products is a critical part of ensuring that only quality essential medicines reach the patients who need them. • In this article, we explore the progress the East African Community's Medi...
Article
Full-text available
• The East African Community (EAC)’s Medicines Regulatory Harmonization (MRH) initiative was created to improve access to quality, safe medicines in the region by simplifying the regulatory process while maintaining a high level of rigor. Building on lessons learned since its launch in 2012, the EAC MRH initiative has created a Roadmap for the Futu...
Article
Full-text available
Independent, science-based regulation of medical products is a critical part of ensuring quality healthcare. When conducted in a transparent, science-based, efficient, accountable, and predictable manner, it can help ensure access to quality products that patients need. • Several factors determine access to medicines, including treatment policy, pr...
Article
Full-text available
Introduction Adequate and sustainable funding of national medicine regulatory agencies (NMRAs) is key for assurance of quality, safety and efficacy of medical products circulating in a market. The study aimed to determine factors affecting NMRAs funding in five East African Community (EAC) countries namely: Burundi, Kenya, Rwanda, Tanzania (Mainlan...
Preprint
Full-text available
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 capaci...
Preprint
Full-text available
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 capaci...
Preprint
Full-text available
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 capaci...
Preprint
Full-text available
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 capaci...
Preprint
Full-text available
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 capaci...
Preprint
Full-text available
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 capaci...
Preprint
Full-text available
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 capaci...
Article
Full-text available
Access to quality-assured medical products improves health and save lives. However, one third of the world's population lacks timely access to quality-assured medicines while estimates indicate that at least 10% of medicine in low- and middle-income countries (LMICs) are substandard or falsified (SF), costing approximately US$ 31 billion annually....
Article
Full-text available
The New Partnership for Africa’s Development (NEPAD) Agency recognizes that Africa is in a period of transition and that this demands exploring and harnessing safe advances made in science-based innovations including modern biotechnology. To advance the science of biotechnology in Africa effectively, while at the same time safeguarding human health...
Article
The African Union’s Pharmaceutical Manufacturing Plan for Africa was established to develop the African pharmaceutical industry, a sector with considerable promise for reducing the burden of disease in Africa. With a projected value of over US$40 billion by the next decade, the sector also has the potential to promote economic growth. Additionally,...
Article
Full-text available
Sound regulatory systems are critical for protecting public health against use of medical products which do not meet international standards of quality, safety and efficacy. This review provides a summary of the current status of National Medicines Regulatory Authorities (NMRAs) in Africa, and various initiatives that have been established to impro...
Technical Report
Full-text available
This report distils the key issues affecting African local pharmaceutical manufacturing and how research and innovation could respond to addressing such issues. It emanates from extensive research involving detailed interviews with key stakeholders including policymakers, manufacturers, pharmaceutical industry associations as well as civil society...
Article
Medicines regulation remains an important but neglected component of promotion and protection of public health because it helps to ensure that patients have access to quality, safe, and efficacious medicines. Investing in the African Medicines Regulatory Harmonization (AMRH) initiative provides an opportunity for strengthening regulatory capacity,...
Article
This paper presents the development and validation of an improved method for the simultaneous analysis of lamivudine (LVD), stavudine (STV) and nevirapine (NVP) using high-performance thin-layer chromatography (HPTLC) with densitometric detection. Separation was performed on silica gel 60F(254) plates. The mobile phase is comprised of ethylacetate,...
Article
In developing countries, the most accessible source of treatment for common conditions is often an informal drug shop, where drug sellers are untrained and operations are unmonitored. We sought to describe a public-private initiative in Tanzania that created a new class of provider in government-accredited drug outlets, which improved the quality o...
Article
This study determined maize-user practices that influence the presence of fumonisin and aflatoxin contamination of maize in food consumed in the rural areas of Tanzania. Samples of the 2005 maize harvest in Tanzania were collected from 120 households and examined for fumonisins and aflatoxins. Information on whether the maize was sorted to remove d...
Article
The Tanzania Food and Drugs Authority piloted the use of Minilab kits, a thin-layer-chromatographic based drug quality testing technique, in a two-tier quality assurance program. The program is intended to improve testing capacity with timely screening of the quality of medicines as they enter the market. After 1 week training of inspectors on Mini...
Article
Full-text available
Fumonisins contaminate maize worldwide resulting in unacceptable fumonisin exposures in people relying on maize as staple food. This study determined fumonisins B1 (FB1) and B2 (FB2) in maize from 120 rural households: 30 from each of four main maize producing regions of Tabora, Ruvuma, Iringa and Kilimanjaro in Tanzania in order to estimate total...
Article
Full-text available
The use of rapid and inexpensive nonlaboratory-based screening tests for drug quality assessments is recommended as a component of a drug quality assurance program in poor resource settings. We have established routine Minilab test procedures to screen product quality and a proficiency testing program to determine the competency of the inspectors a...

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Projects

Project (1)
Project
to provide current knowledge on medicines regulation in Africa to identify new research area on medicines regulation in Africa