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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,
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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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The document is structured into five sections. The first presents the key experiences and challenges that justify a renewal of the EPHFs. The second section updates the groundwork for the exercise of public health and provides a framework to inform the exercise of the new essential functions. The th
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ird section proposes a new integrated approach for implementing the EPHFs. The fourth section presents a new list of 11 EPHFs related to each stage of this integrated approach. Finally, in the last section, considerations are put forth to guide EPHF implementation as a means of strengthening the health sector.
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This publication summarizes the facilitators and barriers that will be encountered in the deinstitutionalization process and identifies useful and proven interventions in Latin American and Caribbean countries. Four areas of work are identified with the respective guidelines or suggestions for actio
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n, which should provide an operational guide for countries that are restructuring mental health services and moving toward the deinstitutionalization of psychiatric care.
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Member States have requested WHO policy guidance on how to facilitate the implementation of national AMS activities in an integrated and programmatic approach. This policy guidance responds to that demand from Member States and is anchored in public health guiding principles in the human health sect
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or. It aims to provide a set of evidence-based and pragmatic recommendations to drive comprehensive and integrated AMS activities under the purview of a central national coordination unit, National AMR steering or coordinating committees or other equivalent national authorities.
Available in English, French, Spanish, Russian, Arabic, Chinese
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Workplaces outside of healthcare facilities can be also settings for transmission of COVID-19. Outbreaks of COVID-19 has been reported in various types of workplaces and job categories.
All workers should be protected from acquiring COVID-19 because of their work. The prevention of COVID-19 in
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work settings should be combined with measures for protecting physical and mental health, safety and wellbeing of workers from other occupational hazards in the operation, closures and reopening of workplaces.
This joint WHO/ILO policy brief provides a summary of the evidence for transmission of COVID-19 in general workplaces and an overview of WHO and ILO recommendations for prevention and mitigation of COVID-19 and for protecting health and safety at work in the context of the pandemic.
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13 May 2021
To avoid a reversal of progress from the adverse impacts of the COVID-19 pandemic, new knowledge and lessons from successful programmatic innovations are urgently needed to improve TB prevention and care. Experience can provide evidence for innovative approaches and strategies to mainta
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in and scale up high-quality TB services. WHO therefore called for case studies on programmatic innovations that address emerging challenges in TB prevention and care during the pandemic in order to collect and disseminate the findings to the TB community. Between November 2020 and February 2021, a total of 23 case studies relevant to the call were accepted from 19 countries in the six regions of WHO. The lessons learnt from these country activities to ensure the continuity of essential services like TB care in the face of the crippling crisis may also inform strategies for minimizing the impact of future emerging pathogens on health services.
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This drill package is part of a broader COVID-19 simulation exercise package, including vaccine tabletop exercises(TTX). For exercises to be most effective, it is recommended they should be part of a comprehensive programme made up of progressively complex exercises, each exercise
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building on the previous one until they are as close to reality as possible
Available in English, Arabic, Chinese, French, Russian, Spanish and Portuguese
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Standard Operating Procedure (SOP) : Waste management of used COVID-19 vaccines vials and ancillary supply
recommended
The purpose of this Standard Operating Procedure (SOP) is to describe the detailed process on how to manage discarded COVID-19 vaccine vials and associated waste after COVID-19 vaccination activities end. The SOP provides clear instructions on how to perform the appropriate treatment and safe dispos
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al of these wastes to minimize any associated health risk with consideration to local context.
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Available in Arabic, Chinese, English, French, Russian and Spanish. You can download a summary of the main report and background documents!
The report demonstrates that the current system—at both national and international levels— was not adequate to protect people from COVID-19. The time it t
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ook from the reporting of a cluster of cases of pneumonia of unknown origin in mid-late December 2019 to a Public Health Emergency of International Concern being declared was too long. February 2020 was also a lost month when many more countries could have taken steps to contain the spread of SARS-CoV-2 and forestall the global health, social, and economic catastrophe that continues its grip. The Panel finds that the system as it stands now is clearly unfit to prevent another novel and highly infectious pathogen, which could emerge at any time, from developing into a pandemic.
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This case study takes a closer look at experiences in three countries and one sub-region, each with a unique profile, a specific set of challenges and opportunities, and differing levels of WASH competencies. Through the lens of the participating National Societies and the communities they serve, th
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is study captures rich layers of learning from multi-country implementation between 2016 to 2020.
The unfolding of the COVID-19 pandemic gives a glimpse of the resulting global restrictions that are testing aspects of National Society capacity and preparedness on the ground. It is an opportunity to take stock of progress and the outlook ahead - to celebrate achievements and share experiences with National Societies and partners contemplating capacity development in emergency WASH in the Asia Pacific region.
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A global hunger crisis -- fuelled by conflict, economic turbulence and climate-related shocks -- has been exacerbated by the COVID-19 pandemic. The number of people experiencing food insecurity and hunger has risen since the onset of the pandemic. The IRC estimates that the economic downturn alone w
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ill drive the number of hungry people up by an additional 35 million in 2021. Without drastic action, the economic downturn caused by COVID-19 will suspend global progress towards ending hunger by at least five years.
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Background paper 10
The Independent Panel for Pandemic Preparedness and Response
May 2021
In the context of the coronavirus disease (COVID-19) pandemic response, WHO identifies young people as a priority target audience with specific concerns, experiences and behaviours. This policy brief provides relevant insights from behavioural evidence and a set of behavioural considerations for tho
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se promoting COVID-19 preventive behaviours among young people. Designers of programmes and initiatives targeting youth may find it helpful to refer to the youth-specific barriers and drivers identified in this policy brief and to prioritize these for testing when planning initiatives targeted at young people.
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This brief summarizes current evidence and guidance for maintaining safe and effective care across the spectrum of maternal, newborn and infant care while protecting mother and child and health care providers during COVID-19. Furthermore, implications of the principle of “do no harm” are reviewe
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d for maternal, newborn and infant care delivery during COVID-19, so that this information is conveniently and readily available to clinical and health system policy leaders and stakeholders in countries and communities. Additionally, considerations for safe oxygen delivery as well as key Infection Prevention and Control (IPC) measures at home and in healthcare facilities for pregnant women, newborns and children are described in detail in the brief.
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A public health emergency operation center (PHEOC) serves as a hub for better coordinating the preparation, response, and recovery for public health emergencies. A functional PHEOC is critical for the implementation of the International Health Regulations (IHR 2005). The Framework for a Public Healt
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h Emergency Operations Centre provides high-level guidance for establishing or strengthening a PHEOC. To establish and/or strengthen a PHEOC, it is vital for Member States to align with standardized policies, guidelines, and tools.
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WHO list of priority medical devices for management of cardiovascular diseases and diabetes
recommended
This publication was developed in response to the need for a reference list of priority medical devices required for management of noncommunicable diseases (NCDs), focusing on cardiovascular diseases and diabetes, especially for low- and middle-income countries to support universal health coverage a
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ctions.
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Many African countries were amongst the most rapid to respond to the emerging threat of COVID-19, implementing large-scale interventions at very early stages of their epidemic. As demonstrated in this document using very simple models, this rapid mobilization and timeliness of implementing control m
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easures is likely to be an important determinant of their success. Indeed, as these measures were relaxed, subsequent waves of disease have been observed in many countries including South Africa, Kenya, Tunisia, Morocco, Sudan and the Democratic Republic of Congo (DRC) where such waves have severely impacted the health system by straining the supply of oxygen and ICU beds and inflicting a heavy toll on healthcare workers, often necessitating the re-imposition of control measures.
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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
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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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