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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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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.
more
Malaria remains a significant public health concern in the SADC region, accounting for 20% of childhood deaths, as well as prompting numerous outpatient visits and hospitalisations. Around three-quarters of the population, including 35 million children under the age of five and 8.5 million pregnant
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women, are at risk. Transmission patterns vary from high and stable in the north to malaria-free in the south, with low, unstable and seasonal zones in between. Although interventions such as indoor residual spraying (IRS), insecticide-treated nets (ITNs/LLINs), intermittent preventive treatment in pregnancy (IPTp), rapid diagnostic tests (RDTs), and artemisinin-based combination therapies (ACTs) have reduced the malaria burden, challenges persist in terms of funding, human resources, surveillance, and cross-border coordination. Achieving malaria elimination in the SADC region requires harmonised regional standards, strengthened surveillance, and improved access to quality treatment and policy prioritisation.
Accessed on 27/08/2025.
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Public health challenges over the past decade have highlighted the importance of approaching health through a holistic lens of human, animal, and environmental sectors, recognizing the need for a collaborative response against shared threats. Zoonotic diseases, transmitted between humans and animals
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through their shared environment, are at the forefront of the threats requiring collaborations that span human health, natural ecosystems, and food systems.
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WHO guideline on balanced national controlled medicines policies to ensure medical access and safety
Access to medicines is essential for attainment of universal health coverage, which is central to achievement of the health-related Sustainable Development Goals. Controlled medicines include those such as opioids, benzodiazepines, barbiturates, amphetamines and others with identified or emergent cl
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inical indications. WHO recognizes that these medicines are necessary for pre- and post-operative care, for sedation, for the management of both acute and chronic pain, for palliative care, as anticonvulsants (anti-epileptics), for the management of anxiety disorders and for the management of substance use disorders, including as opioid agonist therapy (OAT).
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WHO, as the coordinating authority on international health, supports countries in protecting public health through evidence-based policies and actions. Considering the significant health burden and the multiple potential benefits of interventions, the WHO Air Quality, Energy and Health Unit aims to
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support countries by providing evidence, building institutional capacity and leveraging the “health argument” to convene sectors to tackle air pollution and accelerate energy access.
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The WHO handbook “Epidemiological Data Analysis for the Early Warning Alert and Response Network (EWARN) in Humanitarian Emergencies” explains how to collect, analyse, interpret, and share health data during crises such as conflicts or natural disasters. It is a practical guide for health and su
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rveillance officers to detect disease outbreaks early and guide quick public health responses. The document outlines steps for managing data at different levels (local, regional, national), analysing disease trends by time, place, and person, and using indicators to monitor outbreak risks. It also provides methods for interpreting and communicating results clearly to decision-makers to support effective health interventions in emergencies.
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Adolescents and young adults aged 10-24 remain underserved in the global response against HIV. Combination prevention, treatment and care programmes use a mix of evidence-based interventions to meet the current HIV prevention needs of adolescents and young adults. However, there needs to be a focus
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on priority interventions that are evidence-based, practical, contextual and sustainable. This document highlights interventions and recommendations that have passed through the evidence-based lens of the WHO.
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Strengthening global health security to protect the world against future epidemics and pandemics requires well-tested and decentralized capacities for the local detection and rapid containment of outbreaks of infectious disease. For such capacities to translate into effective response actions, ind
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ividuals and teams must be well connected and coordinated, despite differences in the size, geography, technical focus or constituency of their parent institution.
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The document provides a standardized protocol for evaluating the Early Warning Alert and Response Network (EWARN), a surveillance system used during humanitarian emergencies when regular national health surveillance may be disrupted. The purpose of EWARN is to detect outbreaks of communicable diseas
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es early and enable rapid public health response. The guidance explains how the system should be assessed in terms of its structure, implementation, effectiveness, and usefulness. It outlines the key steps of evaluation: preparation, system description, data collection, and post-evaluation reporting. The protocol highlights common challenges observed in previous EWARN implementations, such as delays in establishing the system, limited data quality, weak outbreak response, and lack of clear transition plans back to routine surveillance systems. It emphasizes the need to evaluate both weekly disease reporting and alert verification processes, and to review attributes such as simplicity, data quality, timeliness, sensitivity, and stability. The document also provides templates for interviews, data review forms, and laboratory assessment, as well as guidance on conducting remote evaluations when access is limited. The overall goal of the protocol is to ensure that EWARN functions effectively to detect and respond to outbreaks and that practical recommendations are developed to improve the system’s performance and sustainability in emergency settings.
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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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It is our hope and prayer that the guidance and multiple tools provided herein to manage
the entire lifecycle of a food security program are useful to our food security staff, our
local partners, and our fellow international Cooperating Sponsors throughout the world.
The Camp Managment Toolkit
recommended
Applicable to both IDP and refugee scenarios, the Toolkit incorporates a wide range of relevant information on managing displaced populations living in communal settings (collective centres, spontaneous sites, established camps, etc.). Large scale displacements caused by recent conflict and natural
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disaster events have created a high demand for the Toolkit, which has proven an invaluable resource for field practitioners, government actors and displaced populations since its original release in 2004.
Available in other languages
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Operational Guideline
Participatory Learning and Action Planning; A Facilitator's Guide
