Preferred product characteristics and clinical development considerations
Tropical Medicine and Health (2023) 51:29
The purpose of the guideline is to provide information to stakeholders on the necessary requirements for a complete prequalification dossier for insecticide-treated nets (ITNs). Its aim is to establish the baseline for dossier requirements which are necessary to assess ITN products for the purposes ...of prequalification, describe the data requirements for fulfilling each dossier module, and to provide standardized information for applicants and testing facilities generating data for ITN prequalification dossiers. The document is supported by implementation guidance documents which provide specific information and considerations for how applicants may approach the generation of supporting information and compilation of a complete product dossier.
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This guide provides strategic direction for host countries, event organizers, health authorities, and key stakeholders to effectively plan and conduct Simulation Exercises (SimEx) and After Action Reviews (AARs) for mass gathering events. Packed with practical tools, it empowers users to seamlessly ...integrate these activities into ongoing learning and emergency risk management processes. Aligned with the International Health Regulations (IHR, 2005), the guide serves as a critical resource for strengthening global and national health resilience, ensuring safer and more prepared mass gatherings.
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This operational guidance provides a structured approach to support countries in sustaining priority services for HIV, viral hepatitis and sexually transmitted infections in the context of reduced external funding. The guidance is intended for national governments, public health programmes, communit...y-led organizations, civil society, technical partners and donors working to safeguard priority services, support phased adaptation, protect health outcomes and preserve hard-won gains.
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The Multi-Hazard Early Warning System (MHEWS) Checklist is a practical tool consisting of major components and actions that national governments, community organizations and partners within
and across all sectors can refer when developing or evaluating early warning systems
Despite being a preventable and curable infectious disease, tuberculosis (TB) has continued to elude global controll efforts. In 2023, 8.2 milion people with TB were diagnosed and notified to the WHO, the hightest number ever reported since WHO began tracking.
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...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 guidance synthesizes current evidence on dengue laboratory testing and diagnostics and provides practical recommendations for laboratories, clinicians, public health officials, and programme managers involved in dengue diagnosis, surveillance, and control, in the context of the global emergency.... It includes a diagnostic algorithm for suspected cases, outlining appropriate testing methods based on days post symptom onset.
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The African Palliative Care Association is pleased to publish the first edition of Palliative Care Standards for Africa. The development of these standards was achieved through wide consultation with service beneficiaries and providers, and they have been developed to suit different levels of ... service delivery, from primary to tertiary. These standards are underpinned by the World Health Organization’s definition of palliative care, and recognise that scaling up palliative care requires a public health approach with four pillars: policy, education, drug availability and implementation. In addition, the increasing need to establish specific indicators of quality and effectiveness for palliative care has been a big driving force behind these comprehensive standards. It is APCA’s wish that they will provide a framework for the development of evaluation
and performance indicators that can facilitate programme improvement and development. The standards are designed to allow the development or improvement of palliative care across the different services levels, within the organisational capacity of various service providers. They describe a relationship between primary, intermediary and tertiary level service providers, with expectations for all providers articulated through detailed criteria for each standard. It is therefore expected that these standards will influence the planning and delivery of palliative care services at all levels of health care service delivery.
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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...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 ...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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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...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 Government recognizes the critical role of the built environment in addressing climate change and environmental degradation. To this end, it has identified and empowered the Kenya Building Research Centre to champion and coordinate the government’s green building agenda in relation to climate ...change mitigation and adaptation as stipulated in the Centre’s Strategic Plan (2017/2018 – 2021/2022)
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This adaptation and implementation guide is part of a five-part Caregiver skills training for families of children with developmental delays or disabilities (CST) package providing guidance on caregiver skills training for families of children aged 2–9 years with developmental delays or disabiliti...es.
This adaptation and implementation guide provides information on how to adapt caregiver skills training materials and delivery strategies to the local context. It includes guidance on development and implementation of contextual and cultural adaptation plans.
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In where under-five mortality is high and vitamin A deficiency is a public health problem, two high-dose supplements of vitamin A per year, spaced four to six months apart, can strengthen children’s immune systems and improve their chances of survival.
During much of early childhood – from... 6 months to 5years of age – two high doses of vitamin A every year can prevent blindness and hearing loss, boost children’s immunity against diseases like measles and diarrhoea and provide critical protection against death. Like all forms of malnutrition, vitamin A deficiency is a marker of inequality. In countries where diets are lacking in vitamin A and infections and deaths are prevalent, supplementation programmes give vulnerable children a better chance to survive, develop and thrive.
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The Strategy provides a high-level unifying framework to leverage existing capacities, address barriers and strengthen the use of genomic surveillance in the detection, monitoring and response to public health threats. Genomic surveillance is part of the broader surveillance and laboratory system, a...nd its implementation should reinforce end-to-end capacities including sample collection, diagnostics, data sharing and analysis. The strategy aims to facilitate the connectivity between different disease control programs and surveillance networks. This interoperability will strengthen the cross-cutting essential public health laboratory functions underpinning genomics holistically. The strategy articulates the overarching goal, objectives and strategic actions needed. These are dependent on commitments from countries, partners and WHO for their implementation.
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