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Technical specifications series for submission to WHO prequalification: diagnostic assessment;TSS-3
This template dossier complements and should be used after fulfilling the criteria and preconditions specified in the Process of validation of elimination of kala-azar as a public health problem in South-East Asia. The national kala-azar programme should be in the consolidation phase of elimination;
...
that is, the annual incidence of kala-azar in the implementation unit is maintained below 1 case (new plus relapse) per 10 000 population for a minimum of 3 consecutive years.
The template is designed to help national kala-azar elimination programmes prepare a dossier documenting the essential evidence supporting the request to the World Health Organization (WHO) to validate the status of kala-azar elimination as a public health problem in their country. The information presented in this document will help independent assessors understand the national programme’s specific context, achievements and relevant epidemiological data.
The dossier should be organized according to the following sections:
- Description of the country context and health system capabilities
- Historical data and delineation of endemic areas
- Surveillance and elimination activities
- Epidemiological data
- Vector control strategy and activities
- Post-validation surveillance plan
Once the dossier is prepared, it should be examined and duly endorsed by the National Task Force on kala-azar elimination and/or neglected tropical diseases, or a similar body, before submission to WHO.
more
Having established the goal of eliminating transmission of gambiense human African trypanosomiasis (g-HAT) to humans, the HAT-e-TAG considered which elements should be developed to assess this goal.
How to successfully apply for, administer, and manage the Zithromax® donation for trachoma elimination
Antimicrobial resistance (AMR) is a global public health crisis that resulted in 1.14 million deaths in 2021. According to the Institute for Health Metrics and Evaluation estimates, 96 416 of these deaths occurred in the World Health Organization (WHO) Eastern Mediterranean Region. All 22 countr
...
ies/territories in the Eastern Mediterranean Region are enrolled in the global AMR
surveillance system, and 17 countries/territories reported data in 2024 (for the year 2023). The total number of isolates reported to the system increased sixfold between 2017 and 2022, but the proportion of blood isolates is relatively very low. Most of the data come from public sector laboratories or hospitals, although the private sector has increased its participation in some countries/territories recently. Three pathogens account for three quarters of all the reported pathogens – Escherichia coli
(26%), Klebsiella pneumoniae (23%), and Staphylococcus aureus (22%).
more
Financing Global Health 2023: The Future of Health Financing in the Post-Pandemic Era
Apeagyei A.E., Dieleman J.L., Leach-Kemon K., et al.
Institute for Health Metrics and Evaluation (IHME)
(2024)
CC
IHME’s Financing Global Health report provides an overview of health spending around the world, with a special focus on investments in health in low- and middle-income countries. The report examines how this funding for health is changing each year and forecasts how it may change in the future. Fi
...
nancing Global Health examines where money for health originates and what health issues it funds.
This year, Financing Global Health 2023 looks at how interest payments on loans that many countries took out during the COVID-19 pandemic to keep their economies afloat and their people protected are now straining health budgets. It also details how development partners’ investments in health in low- and middle-income countries – development assistance for health – have changed since reaching historic levels during the COVID-19 pandemic, dropping by $19.4 billion between 2021 and 2023, from $84.0 billion to $64.6 billion.
more
Malaria in pregnancy is a significant health problem in malaria-endemic areas. It not only causes substantial childhood morbidity and mortality but also increases the risks of adverse events for pregnant women and their developing fetuses. Most of the burden in these areas is due to infection with P
...
lasmodium falciparum. Artemisinin-based combination therapy (ACT) has been recommended as first-line treatment for uncomplicated P. falciparum malaria in all populations, including pregnant women in their second and third trimesters, since 2006. However, for women in their first trimester of pregnancy, WHO recommended as first-line treatment a combination of quinine and clindamycin.
Based on a review of the evidence conducted in 2022, WHO now recommends artemether–lumefantrine, the ACT with the most human safety data available, as the preferred treatment for uncomplicated P. falciparum malaria in the first trimester of pregnancy. This document presents all relevant evidence on the effects and safety in early pregnancy of artemisinins and partner medicines used in ACTs from both studies in experimental animals and observational studies in humans.
more
The document outlines essential steps and provides guidance to countries on the adoption and deployment of c-IPTp so that it is integrated into the existing health system. It draws upon best practices and lessons learned from pilot implementation experiences in eight African countries and targets st
...
akeholders at the national level that are involved in the provision of maternal and child services, including national and local policymakers and implementers of malaria, maternal health, child health, reproductive health and community health programmes, and nongovernmental and other organizations.
more
A historic funding crisis is threatening to unravel decades of progress unless countries can make radical shifts to HIV programming and funding. The report highlights the impact that the sudden, large-scale funding cuts from international donors are having on countries most affected by HIV. Yet it a
...
lso showcases some inspiring examples of resilience, with countries and communities stepping up in the face of adversity to protect the gains made and drive the HIV response forward.
more
This global guidance was developed to support malaria-free countries and those that are close to malaria elimination to prevent re-establishment. The document outlines key concepts and principles for preventing re-establishment and provides guidance on strategies, interventions, planning and managem
...
ent. Country examples are included to highlight good practices and illustrate practical applications.
more
The National Strategic Plan on Malaria Prevention and Elimination Period 2021 – 2025 seeks to build on the previous national successes of the National Institute of Malariology, Parasitology, and Entomology (NIMPE) while addressing current challenges to reduce the overall burden of malaria in the S
...
outhern and Central provinces and to initiate elimination activities in remaining focal areas of transmission throughout the country. The overall targets proposed to be reached by 2025 are:
Reduce malaria morbidity rate to below 0.015/1,000 population
Reduce malaria mortality rate to below 0.002/100,000 population
Eliminate malaria in 55 provinces
Ensure no malaria outbreaks
To address the urgent threat of drug resistance, Viet Nam has committed to accelerate efforts to eliminate locally-acquired P. falciparum by 2023.
more
Access to safe, effective and quality-assured health products and technologies is crucial for achieving universal health coverage and primary health care goals. The continued growth of the aging population; increasing burden of noncommunicable diseases; growing burden of mental health issues; climat
...
e change; shifting patterns of vector borne diseases, fungal disease and waterborne diseases; antimicrobial resistance; and new infectious hazards create an ongoing need for equitable access to safe, effective and quality-assured health products and technologies, and renewed investments in research and development for innovative health products and technologies.
The coronavirus pandemic exposed the inequalities in access to health products, highlighting the need for longer-term strategies to strengthen access to health products and technologies outside of and in emergency situations. While technological and scientific advances present an opportunity to increase access to health products and technologies, the risk of increasing inequality due to higher prices for new health products and technologies; the persisting problem of substandard and falsified medical products; a lack of skilled workforce in many low- and middle-income countries; and a lack of data for decisionmaking and for measuring progress present significant challenges.
more
The 2022 report reviews the global malaria diagnostics market and technological landscape to support Unitaid’s 2023–2027 strategy for quality malaria case management. The report highlights the stalled progress of malaria control efforts, the gaps in access to diagnostics and the public health im
...
plications of P. falciparum HRP2/3 gene deletions, which compromise the accuracy of the widely used HRP2-detecting rapid diagnostic tests (RDTs). The report analyses the malaria RDT market, noting supplier diversification, price trends and production shifts resulting from the pandemic. It also addresses the emerging point-of-care G6PD testing market, which is required to ensure the safe radical cure of P. vivax infections. It surveys technological innovation, including digital microscopy, hemozoin tests, nucleic acid detection and biosensors, while emphasising that RDTs and microscopy will remain the mainstay of case management in the near term. The report identifies market shortcomings, access barriers and opportunities to improve malaria case management and diagnostic coverage.
more
This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid diagnostic tests (RDTs) for symptomatic patients. It summarises the minimum performance requirements, includin
...
g analytical and clinical performance standards, and emphasises considerations relating to diverse specimen types, testing environments and user populations in low- and middle-income countries. The guidance is aligned with the criteria and prequalification processes of the WHO Global Malaria Programme, while clarifying that demonstration of clinical utility is outside the scope of prequalification.
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This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid diagnostic tests (RDTs) for symptomatic patients. It summarises the minimum performance requirements, includin
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g analytical and clinical performance standards, and emphasises considerations relating to diverse specimen types, testing environments and user populations in low- and middle-income countries. The guidance is aligned with the criteria and prequalification processes of the WHO Global Malaria Programme, while clarifying that demonstration of clinical utility is outside the scope of prequalification.
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These guidelines have been developed in simple, user-friendly language and they explain the procedures for patients’ access to and the safe management of Schedule I and II drugs that are necessary for the treatment and relief of moderate to severe pain. They provide both procedures for acquisition
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and information on records or documents that are necessary to ensure that these medicines are made available and accessible to patients across the entire health care delivery system (i.e. from tertiary institutions to primary level) and ensuring prevention of illicit non-medical use.
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This report was developed by the WHO TB Vaccine Accelerator Finance and Access working group, co-led by WHO, Gavi and the Government of South Africa. It sets out the working group’s shared vision for equitable access to novel TB vaccines and will advance a shared understanding of the current lands
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cape and its possible evolution in the future. It identifies six urgently needed solutions to accelerate access and financing and highlights the roles of different stakeholders to support the implementation of these solutions.
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The ILO has joined forces with Gallup to carry out a groundbreaking global survey covering 50 countries that sheds further light on the causes of the persistence of HIV-related stigma and discrimination in the world of work.
Building true health security in a global age. Findings and recommendations of the Global Council. In landmark findings based on two years of research and convenings around the world, the new report shows that high levels of inequality are linked to outbreaks becoming pandemics and that inequality i
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s undermining national and global responses, making pandemics more disruptive, deadly, and longer in duration. The report also shows that pandemics increase inequality, fuelling a cycle that research shows is visible not just for COVID-19, but also for AIDS, Ebola, Influenza, Mpox and beyond.
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Rwanda’s mountainous topography makes ground transportation of medical supplies unreliable — some roads stretching into rural areas remain uncared for and unpaved. Between 25 and 40 per cent of all temperature-sensitive medical supplies sent from urban centres to rural health clinics are wasted
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because of an unreliable cold-chain infrastructure. Rural clinics are also often subject to stockouts, and patients in need of specialized blood products, drugs and other supplies are unable to acquire them. Zipline, a US-based health logistics company, aims to address the issue of access to medical supplies, largely leapfrogging traditional modes of transportation and various obstacles. Zipline uses drones to deliver blood and other routine and emergency medical supplies from distribution centres to district hospitals and rural health centres.
Although the company has been celebrated in the media for its operations, there is little scholarly work on its operations and performance. This has led to some confusion over its scale. We aimed to gain insight into the details of Zipline’s business model, including the infrastructure, regulations and government support that make Zipline possible, and to understand its impact on health outcomes in Rwanda. Our work was entirely based on published materials since our research was conducted during the COVID-19 pandemic.
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