Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,... which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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8th IAS Conference on HIV Pathogenesis 19-22 July 2015 Vancouver
Anita Sands Prequalification Team – Diagnostics Essential Medicines and Health Product
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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Since the introduction of penicillin in the early twentieth century, antimicrobial treatments have been utilized not only in human medicine but also in veterinary care – initially to ward off diseases, prevent post-surgery infections, and treat sick farm animals.Global food production... has intensified over the past 50 years due to economic expansion and popu-lation growth. The use of antimicrobials in agriculture – in livestock, fish farming, and even on crops – has grown as well. Antimicrobials are not only used as medicines, but are sometimes also added in low concentrations to animal feed as a way of stimulating growth.
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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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Issue Brief 31: Antimicrobial resistance (AMR) can occur when viruses, bacteria, parasites and fungi change over time. There is no longer a response to medicines, and the infection treatment gets really difficult which increases the risk of a disesase spread, which can lead to severe health problems.... AMR is an increasing threat to global public health worldwide that requires cross-sectional and cross-disciplinary action. It is present in every country and is spurred by several human-made factors, including over- and/or inadequate use of antibiotics, poor hygiene and infection prevention control, and excessive usage of antibiotics outside the health care sector e.g. in life stock production.
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Antimicrobial resistance has become one of the most eminent threats to global health and a rising concern for healthcare specialists. All around the world, many common infections are becoming resistant to the antimicrobial medicines used to treat them, resulting in high morbidity and mortality with ...serious social and economic implications. Additionally, there are few new antibiotics being developed but they are expensive and are not new classes. Antimicrobials are critical in the management of infectious diseases. They are also essential tools for protecting animal health and welfare, and contribute in production of safe food. Inappropriate use of antimicrobials can lead to resistance which is known as the antimicrobial resistance (AMR) resulting in high morbidity and mortality with serious social and economic implications.
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This document provides additional guidance for the responsible and prudent use of antimicrobials in food-producing animals, and should be read in conjunction with the Recommended International Code of Practice for Control of the Use of Veterinary Drugs CAC/RCP 38-1993. Its obj...ectives are to minimize the potential adverse impact on public health resulting from the use of antimicrobial agents in food-producing animals, in particular the development of antimicrobial resistance. It is also important to provide for the safe and effective use of veterinary antimicrobial drugs in veterinary medicine by maintaining their efficacy. This document defines the respective responsibilities of authorities and groups involved in the authorization, production, control, distribution and use of veterinary antimicrobials such as the national regulatory authorities, the veterinary pharmaceutical industry, veterinarians, distributors and producers of food-producing animals.
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In the face of rapid increases in the number of hospitalizations due to COVID-19 in Latin America and the Caribbean, coupled with shortages of human and material resources, including medical equipment and gases, there is a need to redesign models of care in the Region to optimize available resources... and ensure that more patients receive the quantity and quality of oxygen they need. Oxygen is included in the World Health Organization’s list of essential medicines and is used to care for patients at all levels of integrated health services networks. The efficacy of oxygen use in the treatment of patients with respiratory conditions caused by COVID-19 has been demonstrated, but there is great opportunity to improve the effectiveness of its use if it is used in a rational, sustainable, and safe way. Bearing in mind that the efficacy of a health technology is measured by its benefit under actual conditions of use, practical actions can be taken to improve the use of medical oxygen and avoid oxygen shortages. A drug is considered to be used rationally when patients receive it according to their clinical needs, in doses appropriate to their individual needs, for an appropriate period, and at a low cost to them and their community. By providing instruction on the rational use of oxygen and promoting it, negative repercussions can be avoided, such as loss of efficacy as a result of activities related to oxygen storage, distribution, and administration. Rational use of oxygen also involves controlling waste due to leaks in storage and distribution systems, use of gas at incorrect pressures, use of incorrectly adjusted flowmeters, and disconnections, among other problems. Another aspect to consider is the provision of adequate technical support for all oxygen production systems, in terms of maintenance and calibration, availability of electrical energy, and specific knowledge about these systems. For these reasons, a set of guidelines has been put together for the development of an efficient management system to deal with situations of oxygen scarcity, both now and in the future.
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dades infecciosas. Los antimicrobianos eficaces son imprescindibles para las medidas preventivas y curativas, para proteger a los pacientes frente a enfermedades potencialmente mortales y para garantizar que se puedan llevar a cabo procedimientos complejos, como la cirugía y la quimioterapia, con e...scasos riesgos. Sin embargo, el mal uso y el abuso sistemático de estos fármacos en la medicina y la producción de alimentos han puesto en riesgo a todas las naciones. Hay pocos productos de recambio en fase de investigación y desarrollo. Sin medidas armonizadas e inmediatas a escala mundial avanzamos hacia una era posantibiótica en la que infecciones comunes podrían volver a ser mortales.
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This report aims to support countries in the necessary transition toward healthier, more sustainable diets by integrating biodiversity in food-based interventions to support nutrition and health. It is intended to help guide decision-makers in the health, nutrition and other sectors, to:
Consider... the important role of biodiversity in food systems for the development of integrated interventions to support healthy, diverse and sustainable diets;
To focus investments and country support for more comprehensive, coordinated and cross-cutting public health and nutrition projects and policies; and
To strengthen the resilience of food systems, health systems, and societies, each of which are each increasingly compromised by widespread ecological degradation, biodiversity loss and climate change.
Biodiversity at every level (genetic, species and ecosystem level) is a foundational pillar for food security, nutrition, and dietary quality. It is the basic source of variety in essential foods, nutrients, vitamins and minerals, and medicines, and underpins life-sustaining ecosystem services. It is a core environmental determinant of health, often a vital ingredient of healthy nutritional outcomes and livelihoods, gender equality, social equity, and other health determinants.
Biodiversity can play a more prominent role in planning for nutritional outcomes in various ways, e.g. by facilitating the production of nutritious fruits and plant products, sustaining livelihoods through more efficient production and increasing the diversity of products available in markets. This Guidance presents and expands on six core building blocks for mainstreaming biodiversity for nutrition and health:
Cross-sectoral knowledge development and knowledge co-production;
Enabling environments;
Integration;
Conservation and the wider use of biodiversity;
Education and awareness-raising;
Monitoring and evaluation;
This WHO report builds on an unprecedented opportunity to mainstream biodiversity in order to support healthy and sustainable diets, and offers the necessary technical guidance to catalyze and support a transformation of the global food system and transition to healthier, more sustainable diets.
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Antimicrobial resistance (AMR) is a global human, animal, plant and environment health threat that needs to be addressed by every country. The impacts of AMR are wide-ranging in terms of human health, animal health, food security and safety, environmental effects on ecosystems and biodiversity, and ...socioeconomic development. Just like the climate crisis, AMR poses a significant threat to the delivery of the 2030 Agenda for Sustainable Development. The response to the AMR crisis has been spearheaded through the global action plan on antimicrobial resistance (GAP-AMR), developed by the World Health Organization (WHO) in 2015, in close collaboration with the Food and Agriculture Organization of the United Nations (FAO) and the World Organisation for Animal Health (WOAH), and formally endorsed by the three organizations’ governing bodies and by the Political Declaration of the high-level meeting of the United Nations General Assembly on AMR in 2016. In 2022, the three organizations officially became the Quadripartite by welcoming the United Nations Environment Programme (UNEP) into the alliance “to accelerate coordination strategy on human, animal and ecosystem health”.
The aim of the GAP-AMR is to ensure the continuity of successful treatment with effective and safe medicines.
Its strategic objectives include:
• improving the awareness and understanding of AMR;
• strengthening the knowledge and evidence base through surveillance and research;
• reducing the incidence of infection through effective sanitation, hygiene and infection prevention measures; optimizing the use of antimicrobial medicines in human and animal health; and
• developing the economic case for sustainable investment that takes account of the needs of all countries and increasing investment in new medicines, diagnostic tools, vaccines and other interventions.
With the adoption of the GAP-AMR, countries agreed to develop national action plans (NAPs) aligned with the GAP-AMR to mainstream AMR interventions nationally. Individually, the Quadripartite took action to advance AMR interventions in their respective sectors. FAO adopted a resolution on AMR recognizing that it poses an increasingly serious threat to public health and sustainable food production, and developed an AMR action plan to support the resolution’s implementation. For its part, WOAH developed a strategy on AMR aligned with the GAP-AMR, acknowledging the importance of a One Health approach to AMR. Similarly, more recently, UNEP’s governing body, the United Nations Environment Assembly, recognized that AMR is a current and increasing threat and a challenge to global health, food security and the sustainable development of all countries, and welcomed the GAP-AMR and the NAPs developed in accordance with its five overarching strategic objectives
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This Medical Product Alert relates to the recent circulation of two confirmed falsified versions of Quinine
Sulphate circulating in Cameroon and the Democratic Republic of the Congo, containing zero active
pharmaceutical ingredient
Antimicrobials are used in veterinary medicine to treat infectious diseases in animals caused or complicated by microorganisms, mainly bacteria, or to prevent the development or spread of infection in healthy animals.
The GEHM series is an evidence-informed normative product of the WHO
Health and Migration Programme to inform policy-makers on migrationrelated public health priorities. These reviews aim to respond to policy questions identified as priorities by summarizing the best available evidence worldwide an...d proposing policy considerations. By addressing data gaps on the health status of refugees and migrants, the GEHM series aims to support evidenceinformed policy-making and targeted interventions that are impactful and make a difference in the lives of these populations.
This Report, the fourth in the GEHM series reviews the available evidence on barriers to antibiotic access and appropriate use in refugees and migrants. It finds that the available evidence on refugees’ and migrants’ access to and use of antibiotics is scarce and is largely constrained to high-income contexts.
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Le présent document donne des indications supplémentaires pour un usage responsable et prudent des
antimicrobiens chez les animaux élevés pour l’alimentation humaine. II convient de le lire en conjonction
avec le Code d’usages international recommandé pour le contrôle de l'utilisation de...s médicaments
vétérinaires (CAC/RCP 38-1993). Les objectifs visés sont la réduction au minimum de l'incidence
potentiellement défavorable sur la santé publique de l'usage d'agents antimicrobiens chez les animaux
élevés pour l’alimentation humaine et, en particulier, du développement d'une résistance aux antimicrobiens. II importe également d'assurer l'usage sûr et utile des médicaments vétérinaires antimicrobiens en médecine vétérinaire en en maintenant l'efficacité
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STATUTORY INSTRUMENTS | SUPPLEMENT No. 8 28th March, 2014 | STATUTORY INSTRUMENTS SUPPLEMENT | to The Uganda Gazette No. 18 Volume CVII dated 28th March, 2014 | Printed by UPPC, Entebbe, by Order of the Government. | STATUTORY INSTRUMENTS | 2014 No. 29.