This chronology of facts has challenged public health systems worldwide and regulatory bodies are no exception. Regulatory authorities with mechanisms in place to authorize the use of investigational products had to development guidelines and procedures, create task forces and alliances to maximize ...the efficiency of assessment, review and authorizations of medical products. Vaccines are undoubtedly the most complex medical products to develop, from concept to a stage where sufficient evidence of quality, safety and efficacy are collected to provide an assurance that their use will provide more benefits than risks when used in the context of a public health emergency.
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This publication is a companion document to the NDVP National Deployment and Vaccination Plans guidance, which provides a framework for countries to develop their national strategies. As countries face challenges with erratic vaccine supplies, use of multiple vaccine products with different charact...eristics, and the size of populations and their diversity, this document provides operational guidance and information to support planners and immunization programme managers at the national and sub-national levels on microplanning for COVID-19 vaccination implementation.
This Guide is available in English, French, Arabic, chinese, Portuguese, Spanish, Russian
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Following review of evidence and advice from the Technical Advisory Group (TAG) on Tuberculosis (TB) Diagnostics and Laboratory Strengthening, the World Health Organization (WHO) announces that current WHO recommendations for the use of interferon-gamma release assays (IGRA) are also valid for Beij...ing Wantai’s TB-IGRA and Qiagen QuantiFERON-TB Gold Plus products. This expands the range of tests available to detect TB infection. Full details are provided in this WHO policy statement.
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Self-care interventions are evidence-based, quality drugs, devices, diagnostics and/or digital products which can be provided fully or partially outside of formal health services and can be used with or without the direct supervision of health care personnel.
Where HPV tests are available as part o...f the national programme, HPV self-sampling offers an additional option to improve cervical cancer screening coverage.
Self-sampling can help reach a global target of 70% coverage of screening by 2030. Women may feel more comfortable taking their own samples, rather than going to see a health worker for cervical cancer screening.
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Many vaccines and drugs hold the promise of reducing mortality and morbidity among pregnant women and infants living in low- and middle-income countries (LMICs). However, sufficient information on the safety of drugs and vaccines in pregnant women is rarely available at the time of product licensure... or approval. To account for this, active safety surveillance efforts are needed during the post-licensure and post-approval
phase to assess the safety of drugs and vaccines in pregnant women and their offspring. Pregnancy exposure registries (PER) are used to monitor the safety of vaccines and drugs. PERs are observational studies that systematically collect health information on exposure to medical products such as drugs and vaccines during pregnancy. This review demonstrates that a number of resources presently exist in LMICs that perform active safety surveillance in pregnant populations. These results indicate such systems employ a wide variety of approaches, each with their own set of strengths and challenges, as summarized in the final section of the report.
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Diabetes is a serious, chronic disease that occurs either when the pancreas does not produce enough insulin (a hormone that regulates blood sugar, or glucose), or when the body cannot effectively use the insulin it produces. Diabetes is an important public health problem, one of four priority noncom...municable diseases (NCDs) targeted for action by world leaders. Both the number of cases and the prevalence of diabetes have been steadily increasing over the past few decades.
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For thousands of years, humans have been using wildlife for commercial and subsistence purposes. Wildlife trade takes place at local, national and international levels, with different forms of wildlife, such as live animals, partly processed products and finished products. Wildlife is a vital source... of safe and nutritious food, clothing, medicine, and other products, in addition to having religious and cultural value. Wildlife trade also contributes to livelihoods, income generation and overall economic development.
However, wildlife trade can have detrimental effects on species conservation, depleting natural resources, impoverishing biodiversity and degrading ecosystems (Morton et al., 2021). Wildlife trade, whether legal or illegal, regulated or unregulated, can pose threats to animal health and welfare. It also presents opportunities for zoonotic pathogens to spill over between wildlife and domestic animals, and for diseases to emerge with serious consequences for public or animal health and profound economic impacts (IPBES, 2020; Swift et al., 2007; Smith et al., 2009; Gortazar et al., 2014; Stephen, 2021; Stephen et al., 2022; FAO, 2020). The risk of pathogen spillover and disease emergence is amplified with increased interaction between humans, wildlife and domestic animals. The risk of pathogen spillover has also been exacerbated by climate change, intensified agriculture and livestock production, deforestation, and other land-use changes. Wildlife trade is also a risk to ecosystem biodiversity via the introduction of invasive species (Wikramanayake et al., 2021). Therefore, increased effort must be put into understanding the potential consequences of the wildlife trade, mapping and analysing the adjacent risks, and implementing strategies to manage those risks. Reducing wildlife-trade risks not only helps to limit disease but also minimises the negative effects of invasive species. Between 1960 and 2021, invasive alien species caused estimated cumulative damage of around 116 billion euros across 39 countries in the European Union alone, despite strict import regulations (Haubrock et al., 2021). The effect of invasive species is extremely apparent.
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In the context of limited resources, national malaria programmes may need to decide on how to prioritize all WHO-recommended interventions . This guidance document has been developed to support national malaria programmes in prioritization decisions, specifically on the deployment scope and product ...choice of insecticide-treated nets (ITNs). This guidance is to be
followed when programmes do not have sufficient budget to deploy the most effective ITNs to all populations at risk.
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This document summarizes several air quality measurement and modelling methods that can be used to estimate ground-level air pollutant concentrations and presents multiple approaches to monitoring ambient air pollution at different spatial and temporal scales. These methods are crucial for estimatin...g population exposures, which can be defined as the product of the pollutant concentration and the time over which a person is in contact with this pollutant.
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Diabetes is a serious, chronic disease that occurs either when the pancreas does not produce enough insulin (a hormone that regulates blood sugar, or glucose), or when the body cannot effectively use the insulin it produces. Diabetes is an important public health problem, one of four priority noncom...municable diseases (NCDs) targeted for action by world leaders. Both the number of cases and the prevalence of diabetes have been steadily increasing over the past few decades.
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Diabetes is a serious, chronic disease that occurs either when the pancreas does not produce enough insulin (a hormone that regulates blood sugar, or glucose), or when the body cannot effectively use the insulin it produces. Diabetes is an important public health problem, one of four priority noncom...municable diseases (NCDs) targeted for action by world leaders. Both the number of cases and the prevalence of diabetes have been steadily increasing over the past few decades.
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Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Insulin is a hormone that regulates blood glucose. Hyperglycaemia, also called raised blood glucose or raised blood sugar, is a common e...ffect of uncontrolled diabetes and over time leads to serious damage to many of the body's systems, especially the nerves and blood vessels.
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Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Insulin is a hormone that regulates blood glucose. Hyperglycaemia, also called raised blood glucose or raised blood sugar, is a common e...ffect of uncontrolled diabetes and over time leads to serious damage to many of the body's systems, especially the nerves and blood vessels.
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Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Insulin is a hormone that regulates blood glucose. Hyperglycaemia, also called raised blood glucose or raised blood sugar, is a common e...ffect of uncontrolled diabetes and over time leads to serious damage to many of the body's systems, especially the nerves and blood vessels.
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The purpose of these guidelines is to help health workers to participate in the process of continuous surveillance of safety and efficacy of the pharmaceutical products which are used in clinical practice, thus help to achieve the ultimate goal to make safer and more effective treatment available to... patients. This guideline addresses specifically the issues on what to report, why to report, when to report, where to report and how to report.
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WHO, in partnership with the International Society for Prosthetics and Orthotics (ISPO) and the United States Agency for International Development (USAID), has published global standards for prosthetics and orthotics. Its aim is to ensure that prosthetics and orthotics services are people-centred an...d responsive to every individual’s personal and environmental needs. The standards advocate for the integration of prosthetics and orthotics services into health services, under universal health coverage. Implementation of these standards will support countries to fulfil their obligations under the Convention on the Rights of Persons with Disabilities and towards the Sustainable Development Goals, in particular Goal 3: Ensure healthy lives and promote well-being for all at all ages.
The standards provide guidance on the development of national policies, plans and programmes for prosthetics and orthotics services of the highest standard. The standards are divided into two documents: the standards and an implementation manual. Both documents cover four areas of the health system:
policy (governance, financing and information);
products (prostheses and orthoses);
personnel (workforce);
and provision of services.
The Standards have been developed through consultation with experts from around the globe via a steering group, development group and external review group.
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WHO, in partnership with the International Society for Prosthetics and Orthotics (ISPO) and the United States Agency for International Development (USAID), has published global standards for prosthetics and orthotics. Its aim is to ensure that prosthetics and orthotics services are people-centred an...d responsive to every individual’s personal and environmental needs. The standards advocate for the integration of prosthetics and orthotics services into health services, under universal health coverage. Implementation of these standards will support countries to fulfil their obligations under the Convention on the Rights of Persons with Disabilities and towards the Sustainable Development Goals, in particular Goal 3: Ensure healthy lives and promote well-being for all at all ages.
The standards provide guidance on the development of national policies, plans and programmes for prosthetics and orthotics services of the highest standard. The standards are divided into two documents: the standards and an implementation manual. Both documents cover four areas of the health system:
policy (governance, financing and information);
products (prostheses and orthoses);
personnel (workforce);
and provision of services.
The Standards have been developed through consultation with experts from around the globe via a steering group, development group and external review group.
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Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to... understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
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Fact Book on WHO Level I and Level II monitoring indicators - To monitor the progress of efforts to improve the global medicines situation, WHO has developed a system of indicators that measure important aspects of a country’s pharmaceutical situation. Level 1 indicators measure the existence and ...performance of key national pharmaceutical structures and processes. Level II indicators measure key outcomes of these structures and processes in the areas of access, product quality and rational use. These indicators can be used to assess progress over time; to compare situations between countries; and to reassess and prioritize efforts based on the results.
This Fact Book gives the results of the assessment of Level I indicators conducted in 2003 and of Level II indicator surveys conducted between 2002 and 2004
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Noncommunicable diseases (NCDs) such as cancer, cardiovascular disease, diabetes and chronic respiratory diseases and their risk factors are an increasing public health and development challenge in Kazakhstan. This report provides evidence through three analyses that NCDs reduce economic output and ...discusses potential options in response, outlining details of their relative returns on investment. An economic burden analysis shows that economic losses from NCDs (direct and indirect costs) comprise 2.3 trillion tenge, equivalent to 4.5% of gross domestic product in 2017. An intervention costing analysis provides an estimate of the funding required to implement a set of policy interventions for prevention and clinical interventions. A cost–benefit analysis compares these implementation costs with the estimated health gains and identifies which policy packages would give the greatest returns on investment. For example, the salt policy package achieved a benefit-to-cost ratio of 118.4 over 15 years, a return of more than 118 tenge for every 1 tenge invested.
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